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TITLE: A randomized, double-blind trial evaluating the efficacy of palonosetron with total intravenous anesthesia using propofol and remifentanil for the prevention of postoperative nausea and vomiting after gynecologic surgery.ABSTRACT: Palonosetron has potent and long-acting antiemetic effects for postoperative nausea and vomiting (PONV). The aim of this study was to prospectively evaluate the efficacy of palonosetron when used with total intravenous anesthesia (TIVA) using propofol and remifentanil for the prevention of PONV in patients undergoing laparoscopic gynecologic surgery.This prospective double-blind study comprised 100 female American Society of Anesthesiologist physical status I and II patients who were undergoing laparoscopic gynecologic surgery under TIVA. The patients were randomly assigned to two groups-the palonosetron plus TIVA group (palonosetron 0.075 mg i.v., n = 50) and the TIVA group (normal saline 1.5 ml i.v., n = 50). The treatments were given before the induction of anesthesia. The incidence of PONV, severity, number of rescue antiemetics, adverse effects, and patient satisfaction during the first 24 h after surgery were evaluated.The demographic profiles of the patients in the two groups were comparable. The overall incidence of PONV (0-24 h) was significantly lower in the TIVA plus palonosetron group than in the TIVA group (34 vs 58 %, p = 0.027). In particular, during the 6-24 h after surgery, the incidence of PONV (14 vs 30 %, p = 0.03) and the incidence of moderate to severe nausea (6 vs 22 %, p = 0.041) were significantly lower in the TIVA plus palonosetron group than in the TIVA group. There were no significant differences in adverse effects, use of rescue antiemetics or patient satisfaction.Combining palonosetron with TIVA can be considered as a good method to prevent PONV, not only during the short postoperative period but also especially during the 6-24-h period after anesthesia.

TITLE: Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part II: clinical data evaluation.ABSTRACT: White spot lesions (WSL) frequently occur as side-effect of multibracket appliance treatment. The clinical effects of local fluoridation on post-orthodontic WSL and oral health development are however inconclusive.In vivo monitoring of clinical WSL and oral health changes in response to weekly 1.25 per cent fluoride gel application after multibracket appliance treatment.Randomized, single-centre, double-blind, parallel-group, placebo-controlled study.Patients with not less than 1 WSL (modified score 1 or 2) on not less than 1 upper front teeth after debonding.Professional fluoride/placebo gel application during weeks 1-2; self-administered home application (weeks 3-24).Clinical evaluation of WSL index, lesion activity, plaque index, gingival bleeding index, and decayed, missing, and filled teeth index as well as saliva buffer capacity and stimulated salivary flow rate (T0-T5).Random assignment to test (n = 23) or placebo group (n = 23) using a sequentially numbered list (random allocation sequence generated for 50 subjects in 25 blocks of 2 subjects each).The clinical study duration lasted from March 2011 to September 2013.Unblinding was performed after complete data evaluation.Intention-to-treat analysis set comprised 39 participants (test: n = 21, placebo: n = 18).No clinical parameter except stimulated salivary flow rate (fluoride group: 1.1ml/min, placebo group: 0.74ml/min; P = 0.022) showed a statistically significant group difference after 24 weeks.Several adverse events occurred similarly frequent in both groups; none was classified as possibly related to the study product.The number of dropouts was higher than expected and the socio-economic status was not assessed. Furthermore, the unknown level of compliance during the home application phase must be considered as limitation.Based on the results of this study, no clinical effect of post-orthodontic high-dose fluoride treatment on WSL and oral health changes could be detected.The study was registered with ClinicalTrials.gov (Identifier: NCT01329731).The protocol wasn't published before trial commencement.

TITLE: Regular Exercise to Prevent the Recurrence of Gestational Diabetes Mellitus: A Randomized Controlled Trial.ABSTRACT: To investigate the effect of a supervised home-based exercise program on the recurrence and severity of gestational diabetes mellitus (GDM) together with other aspects of maternal health and obstetric and neonatal outcomes.This randomized controlled trial allocated women with a history of GDM to an exercise intervention (14-week supervised home-based stationary cycling program) or to a control group (standard care) at 13±1 weeks of gestation. The primary outcome was a diagnosis of GDM. Secondary outcomes included maternal fitness, psychological well-being, and obstetric and neonatal outcomes. A sample size of 180 (90 in each group) was required to attain 80% power to detect a 40% reduction in the incidence of GDM.Between June 2011 and July 2014, 205 women provided written consent and completed baseline assessments. Of these, 33 (16%) were subsequently excluded as a result of an elevated baseline oral glucose tolerance test (OGTT), leaving 172 randomized to exercise (n=85) or control (n=87). Three women miscarried before the assessment of outcome measures (control=2; exercise=1). All remaining women completed the postintervention OGTT. The recurrence rate of GDM was similar between groups (control 40% [n=34]; exercise 40.5% [n=34]; P=.95) and the severity of GDM at diagnosis was unaffected by the exercise program with similar glucose and insulin responses to the OGTT (glucose 2 hours post-OGTT 7.7±1.5 compared with 7.6±1.6 mmol/L; P>.05). Maternal fitness was improved by the exercise program (P<.01) and psychological distress was reduced (P=.02). There were no differences in obstetric and neonatal outcomes between groups (P>.05).Supervised home-based exercise started at 14 weeks of gestation did not prevent the recurrence of GDM; however, it was associated with important benefits for maternal fitness and psychological well-being.ClinicalTrials.gov, https://clinicaltrials.gov, NCT01283854.

TITLE: Vaginal misoprostol for cervical priming before hysteroscopy in perimenopausal and postmenopausal women.ABSTRACT: To evaluate the effectiveness and possible adverse effects of vaginal misoprostol for cervical priming before hysteroscopy in perimenopausal and postmenopausal women.A total of 105 women scheduled for hysteroscopy were randomly assigned to 2 groups. The study group (n=51) received 400 microg of vaginal misoprostol at least 12 h before the procedure and the control group (n=54) received no cervical priming agent. The primary outcome measure was the number of women who required cervical dilation. Secondary outcomes were cervical width (the largest size of Hegar dilator inserted without resistance) as well as complications and adverse effects.In the misoprostol group 27 women (52.9%) required cervical dilation vs. 53 (98.1%) in the control group (P<0.0001). The largest size of Hegar dilator inserted without resistance was 7.6+/-1.4 mm in the misoprostol group vs. 5.0+/-1.1 mm in the control group (P<0.0001). A similar effect of misoprostol on cervical dilation was also found in the subgroup of treated postmenopausal women. Only 2 women (3.9%) experienced mild lower abdominal pain after misoprostol application.Vaginal misoprostol applied before hysteroscopy reduced cervical resistance and the need for cervical dilation in perimenopausal and postmenopausal women, with only mild adverse effects.

TITLE: Comparative study between clipless laparoscopic cholecystectomy by harmonic scalpel versus conventional method: a prospective randomized study.ABSTRACT: This study was planned to compare the traditional method of laparoscopic cholecystectomy (LC) versus LC using harmonic as regard the safety and efficacy.This study included group A (70 patients) in whom LC was conducted using the traditional method (TM) by clipping both cystic duct and artery and dissection of gallbladder from liver bed by diathermy, and group B (70 patients) LC was conducted using harmonic scalpel (HS) closure and division of both cystic duct and artery and dissection of gallbladder from liver bed by HS. The intraoperative and postoperative parameters were collected including duration of operation, postoperative pain, and complications.HS provides a shorter operative duration than TM (33.21 + 9.6 vs. 51.7 + 13.79, respectively, p = 0.001), with a significant less incidence of gallbladder peroration (7.1% vs. 18.6, p = 0.04) and less rate of conversion to open cholecystectomy but not reach a statistical significance. The amount of postoperative drainage is significantly less in HS (29 + 30 vs. 47.7 + 31, p = 0.001). No postoperative bile leak was encountered in HS, but it occurred in 2.9% of patients in TM. VAS in HS at 12 h postoperative was 3.25 + 1.84 vs 5.01 + 1.2 (p = 0.001) and at 24 h postoperative was 3.12 + 1.64 vs. 4.48 + 1.89 (p = 0.001).HS provides a complete hemobiliary stasis and is a safe alternative to stander clip of cystic duct and artery. It provides a shorter operative duration, less incidence of gallbladder perforation, less postoperative pain, and less rate of conversion to open cholecystectomy.

TITLE: Effects of metabolic modulation by trimetazidine on left ventricular function and phosphocreatine/adenosine triphosphate ratio in patients with heart failure.ABSTRACT: The addition of trimetazidine to standard treatment has been shown to improve left ventricular (LV) function in patients with heart failure. The aim of this study is to non-invasively assess, by means of in vivo 31P-magnetic resonance spectroscopy (31P-MRS), the effects of trimetazidine on LV cardiac phosphocreatine and adenosine triphosphate (PCr/ATP) ratio in patients with heart failure.Twelve heart failure patients were randomized in a double-blind, cross-over study to placebo or trimetazidine (20 mg t.i.d.) for two periods of 90 days. At the end of each period, all patients underwent exercise testing, 2D echocardiography, and MRS. New York Heart Association (NYHA) class, ejection fraction (EF), maximal rate-pressure product, and metabolic equivalent system (METS) were evaluated. Relative concentrations of PCr and ATP were determined by cardiac 31P-MRS. On trimetazidine, NYHA class decreased from 3.04+/-0.26 to 2.45+/-0.52 (P = 0.005), whereas EF (34+/-10 vs. 39+/-10%, P = 0.03) and METS (from 7.44+/-1.84 to 8.78+/-2.72, P = 0.03) increased. The mean cardiac PCr/ATP ratio was 1.35+/-0.33 with placebo, but was increased by 33% to 1.80+/-0.50 (P = 0.03) with trimetazidine.Trimetazidine improves functional class and LV function in patients with heart failure. These effects are associated to the observed trimetazidine-induced increase in the PCr/ATP ratio, indicating preservation of the myocardial high-energy phosphate levels.

TITLE: Electronic monitoring-based counseling to enhance adherence among HIV-infected patients: a randomized controlled trial.ABSTRACT: To investigated the effectiveness of an adherence intervention (AIMS) designed to fit HIV-clinics' routine care procedures.Through block randomization, patients were allocated to the intervention or control group. The study included 2 months baseline measurement, 3 months intervention, and 4 months follow-up. HIV-nurses delivered a minimal intervention ("adherence sustaining") to patients scoring >95% adherence at baseline, and an intensive intervention ("adherence improving") to patients with <95% adherence. Control participants received high-quality usual care.Electronically monitored adherence and viral load.133 patients were included (67 control, 66 intervention), 60% had <95% adherence at baseline, and 87% (116/133) completed the trial. Intent-to-treat analyses showed that adherence improved significantly in the complete intervention sample. Subgroup analyses showed that this effect was caused by participants scoring <95% at baseline (mean difference = 15.20%; p < .001). These effects remained stable during follow-up. The number of patients with an undetectable viral load increased in the intervention group compared to the control group (OR = 2.96, p < .05). Treatments effects on viral load were mediated by the improvements in adherence.The AIMS-intervention was effective and can be integrated in routine clinical care for HIV-infected patients. Future research should study its (cost)effectiveness among more heterogeneous samples and in settings with variable levels of standard care.

TITLE: The effect of low-volume high-intensity interval training on cardiovascular health outcomes in type 2 diabetes: A randomised controlled trial.ABSTRACT: Low-volume high-intensity interval training (HIIT) may be a time-efficient strategy that leads to similar or superior improvements in cardiorespiratory fitness (CRF) and cardiovascular disease (CVD) risk factors when compared with moderate-intensity continuous training (MICT). Our study investigated the effect of low-volume HIIT or MICT versus sham placebo-control (PLA) on central arterial stiffness, hemodynamic responses, and CVD risk factors in adults with obesity and type 2 diabetes (T2D).Eligible participants were previously inactive adults with obesity and T2D. Individuals were randomly allocated to: i) HIIT (1 × 4 min cycling at 90% peak oxygen consumption [V̇O]); ii) MICT (45 min of cycling at 60% VO); or PLA. Training groups exercised thrice weekly for 12 weeks. Central arterial stiffness, hemodynamics and CVD risk factors were assessed at baseline and post-intervention. Analysis of covariance (ANCOVA) was used to examine changes following HIIT, MICT and PLA.Thirty-five participants (age: 55.1 ± 1.4 years, BMI: 36.1 ± 0.8 kg/m) completed the study. A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .03), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s). There was a significant intervention effect for changes in V̇O (p < .01), glycosylated hemoglobin (p = .03), systolic blood pressure (p < .01), and waist circumference (p = .03), which all improved following MICT or HIIT but not PLA; there was no difference between MICT and HIIT.Twelve minutes of low-volume HIIT per week leads to improvements in central arterial stiffness and cardiovascular health in inactive individuals with obesity and T2D.

TITLE: Efficacy of a topical gel containing chitosan, chlorhexidine, allantoin and dexpanthenol for pain and inflammation control after third molar surgery: A randomized and placebo-controlled clinical trial.ABSTRACT: The aim of this study was to evaluate and compare the postoperative effect of a topic gel containing chlorhexidine, chitosan, allantoine and dexpanthenol versus a placebo for pain and inflammation control after third molar surgery.A gel combining 0.2% chlorhexdine, 0.5% chitosan, 5% dexpanthenol, 0.15% allantoin and 0.01% sodium saccharin was selected for this split mouth randomized controlled and double-blind trial including 36 patients with bilaterally and symmetrically impacted lower third molars. The teeth (n=72) were randomly divided into two groups before surgical removal: control group (CG; in which a placebo was given) and experimental group (EG). Swelling, trismus, postoperative pain, wound healing and complications were measured and recorded in order to evaluate differences between the placebo and experimental product.Five patients suffered from an alveolitis in the CG (13.9%), and none in the study group (0%), but no statistically significant difference was found (p=0.063). From day 0 to day 7, trismus and swelling were significantly less pronounced in the EG, and wound healing was considered 'good' in 22.2% for the CG and 97.2% for the EG (p<0.001). Mean VAS scores during the seven postoperative days were statistically lower in the study (2.56±1,19) compared to the placebo group (3.25±1.6) (p=0.002). The mean consumption of analgesic pills during the first 92 hours was also statistically lower in the EG (0.26±0.51) in comparison to the CG (0.56±0.67) (p=0.003).The use of an experimental gel containing chlorhexidine, chitosan, allantoine and dexpanthenol seems to significantly reduce postoperative pain, trismus and signs of inflammation. Future studies should further evaluate, if the gel is effective in dry socket preventing after third molar removal.

TITLE: Capsaicin Supplementation during High-intensity Continuous Exercise: A Double-blind Study.ABSTRACT: To investigate the effect of acute capsaicin (CAP) supplementation on time to exhaustion, physiological responses and energy systems contribution during continuous high-intensity exercise session in runners. Fifteen recreationally-trained runners completed two randomized, double-blind continuous high-intensity exercises at the speed eliciting 90% V̇O (90% s V̇O), 45 minutes after consuming capsaicin or an isocaloric placebo. Time to exhaustion, blood lactate concentration, oxygen consumption during and 20-min post-exercise, energy systems contribution, time to reach V̇O, heart rate and the rate of perceived exertion (RPE) were evaluated. There was no significant difference between conditions for time to reach V̇O (CAP:391.71±221.8 vs. PLA:298.20±174.5 sec, ES:0.58, p=0.872), peak lactate (CAP:7.98±2.11 vs. PLA:8.58±2.15 µmol, ES:-0.28, p=0.257), time to exhaustion (CAP:654.28±195.44 vs. PLA:709.20±208.44 sec, ES:-0.28, p=0.462, end-of-exercise heart rate (CAP:177.6±14.9 vs. PLA:177.5±17.9 bpm, ES:-0.10, p=0.979) and end-of-exercise RPE (CAP: 19±0.8 vs. PLA: 18±2.4, ES: 0.89, p=0.623). In conclusion, acute CAP supplementation did not increase time to exhaustion during high-intensity continuous exercise nor alter physiological responses in runners.

TITLE: Pharmacological Prophylaxis of Atrial Fibrillation After Surgical Myocardial Revascularization.ABSTRACT: Postoperative Atrial Fibrillation (POAF) is associated with a higher rate of postoperative complications and mortality, as well as with longer hospitalization and increased treatment costs. We have designed and performed a randomized, trial of pharmacological prophylaxis in which the event of interest is POAF.The aim of this study is to reduce the risk of postoperative, complications associated with this arrhythmia.We included 240 stable patients with a coronary heart disease, who were referred to elective surgical revascularization of the myocardium. The patients were assigned into three groups of 80 patients each: group A (BB, beta blocker, comparator), group B (BB+ Amiodarone) and group C (BB + Rosuvastatin). The goal was to establish whether intervention by combination therapy was more useful than a comparator.An event of interest (POAF) has occurred in 66 of the total 240 patients. Number of new POAF cases is the lowest in Group B, 14 (17.5%) compared to 25 (31.25%) new cases in the comparator group, and 27 new cases (33.75%) in group C. Absolute risk reduction was 13.75%, ≈14% less POAF in group B compared to comparator. Relative risk reduction was 56% (RR 0.56, p = 0.04). Number Needed to Treat was 7.27. In group C, 33.75% of patients developed POAF. Absolute risk was insignificantly higher in group C (2.5%, NS) compared to the comparator .The number needed to harm was high, 40.The results of our research show that prophylaxis of POAF with combined therapy BB + Amiodarone was the most efficient one.

TITLE: Treatment with carvedilol improves survival of patients with acute-on-chronic liver failure: a randomized controlled trial.ABSTRACT: In addition to the portal pressure reducing effect, non-selective beta blockers (NSBBs) have possible immunomodulatory and effect in reducing bacterial translocation. Recently, it has been shown that patients who are already on NSBBs should be continued on them (if feasible), if acute-on-chronic liver failure (ACLF) develops. It, however, remains unknown if patients with ACLF and no or small esophageal varices at presentation will benefit from the use of NSBBs. We studied the efficacy and safety of carvedilol in patients with ACLF in reducing mortality, variceal bleeding and non-bleeding complications.136 patients with ACLF (with no or small esophageal varices and HVPG ≥ 12 mmHg) were randomized to either carvedilol (n = 66) or placebo arms (n = 70).Within 28 days, 7 (10.6%) of 66 patients in the carvedilol group and 17 (24.3%) of 70 in the placebo group died (p= 0.044). Fewer patients in the carvedilol compared to placebo group developed acute kidney injury (AKI) (13.6% vs 35.7%, p = 0.003 and spontaneous bacterial peritonitis (SBP) (6.1% vs 21.4%, p= 0.013). Significantly, more patients in the placebo group had increase in APASL ACLF Research Consortium-ACLF grade (22.9% vs 6.1%, p= 0.007). There was no significant difference in the 90-day transplant-free survival rate and development of AKI, SBP, non-SBP infections (including pneumonia) and variceal bleed within 90 days, between the two groups.In ACLF patients with either no or small esophageal varices and HVPG ≥ 12 mmHg, carvedilol leads to improved survival and fewer AKI and SBP events up to 28 days. CLINICALTRIALS.NCT02583698.

TITLE: Spontaneous alveolar bone loss after 4NQO exposure in Wistar rats.ABSTRACT: This study evaluated the effect of an experimental carcinogenic, 4-Nitroquinoline 1-oxide (4NQO), in the spontaneous alveolar bone loss (ABL) in an animal model.Twenty-two male Wistar rats were included in this study. They were randomly divided into two groups: the control group (n = 10) received food and water ad libitum, and the test group (n = 12) receive the same food; however, 25 ppm of 4NQO was diluted in the drinking water. All animals were euthanized after 20 weeks, and the tongues were removed and analyzed macroscopically to determine the presence of oral mucosal lesions. All specimens were paraffin-embedded and histological sections were obtained. The microscopic analysis was based on routine procedure (haematoxylin and eosin stain). The analysis of spontaneous ABL was performed by a calibrated examiner using standardized photographs and imaging software. Differences in spontaneous ABL were assessed among the three resulting groups: control, 4NQO with oral squamous cell carcinoma (OSCC), and 4NQO without OSCC.In the 4NQO-treated group, nine animals developed OSCC. The animals in the 4NQO with OSCC group presented significantly more spontaneous ABL (0.65 ± 0.21 mm) than the control group (0.34 ± 0.05) (p < 0.001). The animals in the 4NQO without OSCC group showed a mean spontaneous ABL of 0.47 ± 0.13 mm, which was not statistically significant different when compared to the control group (p = 0.096).It was concluded that the presence of OSCC enhanced spontaneous ABL in Wistar rats when compared to control animals. Additionally, it was shown that, solely, administration of 4NQO may not be considered responsible for alveolar bone destruction.

TITLE: The potential long-term neurological improvement of early hyperbaric oxygen therapy on hemorrhagic stroke in the diabetics.ABSTRACT: Although Hyperbaric oxygen therapy (HyperBOT) attract our attention successfully these days, it is still full of controversy on the treatment of acute stroke. The aim of this study is to assess the potential long-term neurological consequences and safety of using HyperBOT on intracerebral hemorrhage (ICH) in the diabetics.In this prospective, randomized controlled trial, 79 diabetes patients suffering from acute ICH were randomized to treat for 60 min in a monoplace hyperbaric chamber pressurized with pure oxygen to 2.5-atm absolute (ATA) in the HyperBOT group or 1.5 ATA in the normobaric oxygen therapy (NormBOT) group, which was performed as control. Both short-term and long-term neurological consequences were studied and compared in each group on National Institutes of Health Stroke Scale [NIHSS], Barthel Index, modified Rankin Scale [mRS] and Glasgow Outcome Scale [GOS]. The related complications or side-events of all patients were recorded as well at the final follow-up of six months after onset.No distinct difference was observed between each group at one month follow-up. However, in the long-term follow-up of six months, a higher frequency of patients in the HyperBOT group resulted into good outcome with a relative high neurological consequence compared with the NormBOT group (Barthel Index: 85.1% versus 65.6%, P = 0.080; mRS: 89.4% versus 68.8%, P = 0.045; GOS: 83.0% versus 62.5%, P = 0.073; NIHSS: 80.9% versus 56.2%, P = 0.035).Early HyperBOT was found to be safe and effective with regards to the long-term neurological outcome of diabetic patients suffering from ICH.

TITLE: Hyoscine N-Butylbromide for Preventing Propofol Injection Pain: A Randomized, Placebo-Controlled and Double-Blind Study.ABSTRACT: In this study, the aim was to investigate the effect of hyoscine N-butylbromide (HnBB) pretreatment on pain during propofol injection.In this prospective, randomized, placebo-controlled and double-blind trial, 60 patients scheduled to undergo routine outpatient surgery under general anesthesia were randomly allocated to 2 groups, the HnBB (n = 30) and sodium chloride (n = 30) groups. Twenty seconds after the injection of 20 mg HnBB or 0.9 % sodium chloride, a 50-mg dose of propofol was injected in 2-3 s. Ten seconds later, the pain intensity was assessed using a 4-point scale: no pain (0), mild (1), moderate (2), and severe (3) pain. The Student t test was used for the analysis of parametric data and the Pearson χ2 test for categorical data.The occurrence of pain in the HnBB group (43.3%) was significantly lower than the control group (73.3%) (p < 0.018). Of the 30 patients in each group, 10 in the control group and 3 in the HnBB group experienced severe pain (p = 0.001).Pretreatment with 20 mg HnBB significantly reduced propofol injection pain compared to placebo.

TITLE: Effects of anesthetics on early postoperative cognitive outcome and intraoperative cerebral oxygen balance in patients undergoing lung surgery: a randomized clinical trial.ABSTRACT: One-lung ventilation (OLV) may impair cerebral oxygen balance and induce postoperative cognitive dysfunction (POCD). It is unclear whether the type of anesthetic influences the incidence of POCD in patients undergoing OLV. This prospective study compared the incidence of POCD and intraoperative cerebral oxygen desaturation in OLV patients anesthetized with propofol vs sevoflurane during lung surgery.There were 148 participants enrolled in this study and randomized equally to either the propofol or the sevoflurane group. Anesthesia was maintained with either propofol or sevoflurane combined in both groups with fentanyl and epidural anesthesia. Regional cerebral oxygen saturation (rSO2), jugular bulb venous oxygen saturation (SjO2), and the incidence of cerebral oxygen desaturation (rSO2 or SjO2 < 50% or rSO2 < 80% of baseline) were measured during anesthesia. Cognitive function was assessed using seven neurocognitive tests two days preoperatively, five days postoperatively (primary outcome), and three months postoperatively. Bivariable and multivariable regression analyses were conducted to identify factors associated with POCD.Rates of POCD did not differ statistically between groups five days postoperatively (propofol, 16/72 patients; sevoflurane, 24/72 patients; RR, 0.67; 95% CI, 0.39 to 1.15; P = 0.14) or three months postoperatively (propofol, 9/60 patients; sevoflurane, 12/58 patients; RR, 0.73; 95% CI, 0.33 to 1.59; P = 0.42). Only three subjects per group showed intraoperative cerebral oxygen desaturation. Multivariable regression analysis revealed older age as an independent predictor of POCD.No statistically significant difference in the incidence of POCD could be detected between the sevoflurane and propofol anesthesia groups. Postoperative cognitive dysfunction was relatively frequent following OLV in both groups. (UMIN 000002826).

TITLE: Nurse-Delivered Screening and Brief Intervention Among College Students with Hazardous Alcohol Use: A Double-Blind Randomized Clinical Trial from India.ABSTRACT: To determine the effectiveness of individual-based, nurse-delivered, on-campus screening and brief intervention (SBI) for hazardous alcohol use among college students.It was a parallel-design, double-blind, randomized controlled trial. Out of 793 students screened, 130 met the selection criteria of hazardous alcohol use, defined by alcohol use disorder identification test (AUDIT) score 8-19. Participants were randomly allocated to either SBI or general advice group. Both interventions were delivered by one specially trained nurse. Outcome was assessed after 3 months. Primary outcome was the change in the mean AUDIT score and the secondary outcome was difference in the proportion of students transited from the high- to low-risk category of AUDIT. General linear model with repeated measures and logistic regression were used to determine the primary and secondary outcome, respectively.Majority (80.7%) of the participants were men. Among all the baseline demography and clinical characteristics, only family history of alcohol use was significantly different in the groups. Intention to treat analysis showed a significant but small effect (0.16) of SBI on the mean AUDIT score. Gender did not moderate the effect. SBI was also observed to have a significant effect (adjusted odds ratio 3.7 95% CI 1.529-8.850) on shifting the students from high- to low-risk AUDIT zone.SBI among college students is acceptable and has a small but significant effect on alcohol use. In countries like India, where despite the increasing magnitude of hazardous drinking in students no formal system exists to deal with the problem, SBI might be useful.

TITLE: A randomized pilot trial of an integrated school-worksite weight control program.ABSTRACT: Worksite provision of paid time off for parent participation in a school-based healthy weight program may improve treatment adherence and outcomes. The current pilot study examined whether parents who received worksite support for attendance at a school-based healthy weight program would attend more sessions, lose more weight, and make healthier changes in home food environments than parents who did not receive worksite support.Thirty-eight urban, low-income African American and Mexican American mothers of kindergartners were randomized to an integrated school-parent-worksite program that targeted healthy home food environments and energy balance self-monitoring or the identical school-based program without worksite support. Ten sessions were delivered to parent participants during afterschool hours. Process measures included session attendance and energy balance log completion. Outcome measures included parent body mass index (BMI) change, child BMI z-score change, and home food inventory (HFI) score changes over 12 months.RESULTS showed better weight change for parents (i.e., BMI unit reduction of 1.4 vs. 0.3 in comparison group, p = .001), increased parental attendance, and improvements in the home food environment when parents received paid time off from their worksite for their participation in the healthy weight program. Child weight change was also observed despite no direct contact with children.The current pilot study provides support for the hypothesis that worksite support for school-based interventions may improve health outcomes that depend on parental involvement. Removing barriers to attendance in a healthy weight program resulted in improved treatment adherence and outcomes in low-income, minority parents and children.

TITLE: Injection of intrathecal normal saline in decreasing postdural puncture headache.ABSTRACT: Postdural puncture headache (PDPH) is the most common and still unresolved postoperative complication of spinal anesthesia. Although there are several positive results of intrathecal saline injection for the treatment of PDPH and prophylaxis after accidental dural puncture, the effect of deliberate intrathecal saline injection before spinal anesthesia has not been examined. The objective of our study was to evaluate the effect of prophylactic administration of intrathecal normal saline in decreasing PDPH.One hundred healthy women (ASA physical status I) of age between 18 and 35 years scheduled for elective term cesarean delivery under spinal anesthesia were included. Patients were randomly divided into two equal groups. Group C received 2.5 ml (12.5 mg) hyperbaric bupivacaine 0.5 % as a control, and group S received intrathecal normal saline 5 ml before intrathecal injection of 2.5 ml (12.5 mg) hyperbaric bupivacaine 0.5%. The incidence and severity of PDPH were assessed after 48 h and again 3-7 days after operation.Basal characteristics were statistically similar in both groups (P > 0.05). The incidences of moderate and severe PDPH during first postoperative 48 h were not different between the groups (P = 0.24). However, the frequency of PDPH after 3-7 days was statistically higher in group C in compared with group S (16 vs. 2 %, P = 0.03). Totally the frequency of PDPH was higher in group C (24 vs. 2%, P = 0.002).Administration of normal saline (5 ml) before intrathecal administration of hyperbaric bupivacaine as a preventive approach is an effective and simple way to minimize PDPH in patients undergoing cesarean section.

TITLE: Effectiveness of aerobic physical training for treatment of chronic asymptomatic bacteriuria in subjects with spinal cord injury: a randomized controlled trial.ABSTRACT: To evaluate the effectiveness and safety of aerobic physical training for treatment of chronic asymptomatic bacteriuria in subjects with spinal cord injury.Randomized controlled trial.University hospital.Forty-two participants with spinal cord injury between C8 and T12 segments were randomly assigned to intervention or control groups.In the intervention group, subjects received a risk evaluation, stress test and urinary culture before the start of the study and after 16 weeks. The study consisted of aerobic physical conditioning with moderate intensity for the intervention group while the control group was asked to maintain their daily life activities.Increase of estimated peak oxygen consumption and also if there was a decrease in the proportions of positive urinary culture.The intervention group showed an increase of estimated peak oxygen consumption of between 939 (714-1215) and 1154 (1005-1351) mL/min (P = 0.009) and a reduction of chronic asymptomatic bacteria of between 52.3% (29.8-74.3%) and 14.2% (3-36.3%) (P < 0.001). No adverse effects related to physical activity were recorded during the period of training.The regular practice of physical activity of moderate intensity applied to patients with spinal cord injury may be an effective and safe method for the treatment of chronic asymptomatic bacteriuria.

TITLE: Osteoprotegerin levels decrease during testosterone therapy in aging men and are associated with changed distribution of regional fat.ABSTRACT: The cardiovascular effects of testosterone treatment are debated. Osteoprotegerin (OPG) is an independent marker of cardiovascular risk. We investigated the effect of testosterone therapy on OPG levels in aging men with low normal bioavailable testosterone levels. A randomized, double-blinded, placebo-controlled study of 6 months testosterone therapy (gel) in 38 men aged 60-78 years with bioavailable testosterone <7.3 nmol/l and waist circumference >94 cm was performed. Clinical evaluation, OPG, and C-reactive protein (CRP) measurements were carried out. Lean body mass (LBM), total fat mass, and bone mineral density (BMD) were established by dual X-ray absorptiometry. Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) were measured by magnetic resonance imaging. Power calculation was based on an increase in LBM during testosterone therapy and responders were defined as testosterone treated patients with increased LBM (Δ LBM positive), n=14. Data are presented as median (interquartile range). Testosterone therapy decreased total fat mass and SAT, whereas VAT was unchanged (n=38). OPG levels decreased during testosterone therapy (from 2.0 (1.9-2.5) to 1.9 (1.6-2.2) ng/ml, p<0.05 vs. placebo), whereas CRP levels were unchanged (n=38). In responders to testosterone therapy (n=14), ΔOPG levels were inversely associated with ΔSAT (r= - 0.60, p=0.03) and positively associated with ΔVAT (r=0.56, p=0.04). OPG levels decreased during testosterone therapy suggesting decreased cardiovascular risk. Decreased OPG levels were associated with changes in regional fat distribution and future studies are needed to further evaluate the association between OPG and regional fat mass distribution.

TITLE: Terlipressin decreases vascular endothelial growth factor expression and improves oxygenation in patients with acute respiratory distress syndrome and shock.ABSTRACT: Recent clinical data suggest that treatment with terlipressin (TP) may be more advantageous for septic shock than catecholamines. However, it is unknown whether TP would be effective for acute respiratory distress syndrome (ARDS) patients with shock.The aim of this study was to compare the impact of TP vs. dopamine on hemodynamic variables and vascular endothelial growth factor (VEGF) in ARDS patients with shock.We studied 32 ARDS patients with shock despite fluid loading, who were randomized to receive TP (16 patients) or dopamine (16 patients). TP was administered as a continuous intravenous dose of 1.3 μg/kg/h and dopamine was administered in doses up to 20 μg/kg/min to maintain a mean arterial pressure of 70 ± 5 mm Hg for 48 h. Hemodynamic changes, ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO(2)/FiO(2)), and VEGF were recorded prospectively.There was a significant correlation between the plasma VEGF level and the lung injury score at baseline (r = 0.387, p < 0.01). VEGF concentrations significantly decreased from baseline levels in the TP group (p < 0.05) at 48 h; there was no difference in the dopamine group (p > 0.05) at 48 h vs. baseline. There was no significant difference in the tumor necrosis factor-α concentration between the groups.TP treatment has the potential to inhibit VEGF and improve oxygenation in patients with shock in the early stage of ARDS.

TITLE: The effect of regular consumption of lupin-containing foods on glycaemic control and blood pressure in people with type 2 diabetes mellitus.ABSTRACT: Type 2 diabetes mellitus is a metabolic disorder characterized by high glucose and insulin resistance. It is strongly linked to lifestyle, including poor diet and physical inactivity. Lupin is a novel food ingredient, rich in protein and fibre with negligible sugar and starch, which can be incorporated into various foods to reduce glycaemic load. Regular consumption of lupin-enriched foods may be a novel and easily achievable means of reducing overall glycaemic load and improving glycaemic control in diabetes.To determine whether regular consumption of lupin-enriched foods can improve glycaemic control and lower blood pressure in people with type 2 diabetes mellitus.Fourteen men and 8 women (mean age 58.0 ± 6.6 years and BMI 29.0 ± 3.5 kg m-2) with type 2 diabetes mellitus were recruited from the general population to take part in a double-blind, randomised, controlled cross-over study. Participants consumed lupin or control foods for breakfast and lunch every day, and for dinner at least 3 days per week during the 8-week treatment periods. Lupin-enriched foods consisted of bread, pasta, Weetbix™ cereal and crumbs, with energy-matched control products. Treatments were completed in random order with an 8-week washout period. All participants monitored their blood glucose levels pre- and post-breakfast and lunch, and their blood pressure in the morning and evening, 3 days per week for the duration of each treatment period.Seventeen participants completed both treatment arms, with all 22 participants (14 males, 8 females) analysed on an intention-to-treat basis. Eight weeks consumption of lupin-enriched food had no significant effect on mean blood glucose levels (mean difference: -0.08 ± 0.06 mmol L-1, p = 0.214) or post-prandial blood glucose levels (-0.13 ± 0.10 mmol L-1, p = 0.196). There was no effect on home systolic (-0.4 ± 0.4 mmHg, p = 0.33) or diastolic (0.3 ± 0.3 mmHg, p = 0.321) blood pressure and heart rate (0.5 ± 0.3 bpm, p = 0.152), and no effect on body weight throughout the treatment periods.Regular consumption of lupin-enriched foods had no significant effect on glycaemic control or blood pressure in people with type 2 diabetes mellitus.

TITLE: Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections.ABSTRACT: The incidence of nosocomial infections, predominantly gastrointestinal and respiratory, in children in developed countries is high, ranging from 5% to 44%. There is no effective strategy for preventing these infections. The objective of our study was to investigate the role of Lactobacillus GG (LGG) in preventing nosocomial gastrointestinal and respiratory tract infections at a pediatric hospital.We conducted a randomized, double-blind, placebo-controlled trial of 742 hospitalized children. They were randomly allocated to receive for their hospitalization LGG at a dose of 10(9) colony-forming units in 100 mL of a fermented milk product (LGG group, n = 376) or placebo that was the same postpasteurized fermented milk product without LGG (placebo group, n = 366).In the LGG group, compared with the placebo group, we found a significantly reduced risk for gastrointestinal infections (relative risk [RR]: 0.40 [95% confidence interval (CI): 0.25-0.70]; number needed to treat: 15 [95% CI: 9-34)], respiratory tract infections (RR: 0.38 [95% CI: 0.18-0.85]; number needed to treat: 30 [95% CI: 16-159]), vomiting episodes (RR: 0.5 [95% CI: 0.3-0.9]), diarrheal episodes (RR: 0.24 [95% CI: 0.10-0.50]), episodes of gastrointestinal infections that lasted >2 days (RR: 0.40 [95% CI: 0.25-0.70]), and episodes of respiratory tract infections that lasted >3 days (RR: 0.4 [95% CI: 0.2-0.9]). Groups did not differ in hospitalization duration (P = .1).LGG administration can be recommended as a valid measure for decreasing the risk for nosocomial gastrointestinal and respiratory tract infections in pediatric facilities.

TITLE: Effect of tiotropium in men and women with COPD: results of the 4-year UPLIFT trial.ABSTRACT: Gender differences may occur in many chronic diseases. We have examined the influence of gender in chronic obstructive pulmonary disease (COPD) on long-term responses to tiotropium.Subgroup analysis of data from the Understanding the Potential Long-term Impact of Tiotropium (UPLIFT) trial (4-year, randomized, double-blind, placebo-controlled trial of tiotropium in patients with COPD).Of 5992 patients, 75% were men and 25% women. Mean age was 65 and 63 years, respectively. Baseline post-bronchodilator forced expiratory volume in 1s (FEV(1))=47% predicted(men) and 49% predicted(women). St George's Respiratory Questionnaire (SGRQ) total score was 44.9 and 48.7units, respectively. At 48 months, improvement in trough FEV(1) over control was 92mL(men) and 77mL(women) (p<0.001 for both), with no differences in the rate of decline (trial primary endpoint). Hazard ratio (HR) (95% confidence interval [CI]) for first exacerbation (tiotropium/placebo) was 0.87(0.81, 0.93)(men) and 0.83(0.74, 0.94)(women). Number of exacerbations (per patient-year) was reduced with tiotropium in men (from 0.82 to 0.71) and women (from 0.92 to 0.77) (p<0.005 for both). HR (95% CI) for a hospitalized exacerbation was 0.89(0.79, 0.99) and 0.77(0.62, 0.94), respectively. HR (95% CI) for mortality during treatment was 0.85(0.72, 0.99)(men) and 0.85(0.62, 1.18)(women). Improvements in SGRQ total score (tiotropium-control) at 1, 2, 3 and 4 years were: -2.8, -2.3, -3.6, -2.4(men) and -2.7, -2.6, -2.6, -2.1(women) (p<0.05 for all).Long-term treatment of COPD with tiotropium improves lung function, exacerbations and health status in men and women, with similar magnitudes of benefit. Boehringer Ingelheim trial 205.235; ClinicalTrials.gov: NCT00144339.

TITLE: Two per cent alcoholic chlorhexidine versus alcoholic five per cent povidone-iodine for the prevention of perineural catheter colonisation: The CHLOVEPI randomised, controlled trial.ABSTRACT: Multimodal analgesia, including a regional technique using perineural catheters (PNCs), is recommended for the treatment of moderate-to-severe acute postoperative pain. Perineural catheters are at risk of bacterial colonisation. In this study, we compared the cutaneous antiseptic efficacy of 2% alcoholic chlorhexidine and povidone-iodine-alcohol for preventing the bacterial colonisation of PNCs in orthopaedic surgery.We performed a randomised, controlled trial, comparing two cutaneous antisepsis strategies, one based on 2% alcoholic chlorhexidine and the other on povidone-iodine-5% alcohol, for placed PNCs before orthopaedic surgery. The primary endpoint was the incidence of catheter bacterial colonisation (threshold > 1000 colony-forming units/ml). The secondary endpoints were the incidence of catheter-related infections and the adverse effects of the antiseptic solutions.From November 2016 to May 2018, we included 113 patients in this study. The use of alcoholic chlorhexidine was associated with a lower incidence of catheter colonisation (15.5% (n = 9) versus 32.7% (n = 18); OR: 0.28 [0.09-0.77], p =  0.01). No catheter-related infections or adverse effects of antiseptic solutions were observed in either group. The risk factors associated with colonisation were a duration of catheter use ≥ 3 days (p =  0.04) and obesity (p = 0.005). The most frequently identified bacterium was Staphylococcus epidermidis.Skin disinfection with 2% alcoholic chlorhexidine decreases bacterial colonisation rates for placed perineural catheters.

TITLE: Determination of isotretinoin in human plasma by high performance liquid chromatography-electrospray ionization mass spectrometry.ABSTRACT: A rapid, sensitive and specific high performance liquid chromatography-electrospray ionization mass spectrometry (LC-ESI-MS) method for the quantification of 13-cis-retinoic acid (isotretinoin) in human plasma has been developed. Acitretin was employed as the internal standard (IS). The analytes were chromatographically separated on a Shimadzu Shim-pack VP-ODS C18 column (150 mm × 2.0 mm I.D.) with a mobile phase consisting of acetonitrile and water (90:10, v/v). Detection was performed on a single quadrupole mass spectrometer using an electrospray ionization interface with the selected-ion monitoring (SIM) mode. The method showed excellent linearity (r=0.9989) over the concentration range of 10-1500 ng/mL with good accuracy and precision. The intra- and inter-batch precisions were within 10% relative standard deviation. The recoveries were more than 80%. The validated method was successfully applied to a preliminary bioequivalence study of isotretinoin in 20 Chinese healthy male volunteers.

TITLE: Children's familiarity with snack foods changes expectations about fullness.ABSTRACT: Palatability is regarded as a major determinant of children's energy intake. However, few studies have considered nonhedonic beliefs about foods. In adults, there is emerging evidence that expectations about the satiating properties of foods are an important determinant of meal size, and these beliefs are learned.We measured and quantified children's expected satiation across energy-dense snack foods by using a method of adjustment. Participants changed a comparison-food portion (pasta and tomato sauce) to match the satiation that they expected from a snack food. We predicted that children who were especially familiar with snack foods would expect the foods to generate greater satiation and that children who were unfamiliar with snack foods would match expected satiation on the basis of the physical characteristics (perceived volume) of the foods.Seventy 11- to 12-y-old children completed measures of expected satiation, perceived volume, familiarity, and liking across 6 snack foods.As anticipated, familiarity and expected satiation were positively related (r = 0.37, P = 0.002), and this association remained after liking was controlled for. Furthermore, expected-satiation and perceived-volume judgments were more dissimilar as familiarity with the foods increased.Our findings highlight the role of learning in shaping children's beliefs about the postingestive effects of the consumption of foods; children who ate the foods more often expected them to deliver greater satiation. Furthermore, our findings suggest that, in the absence of prior experience, children rely on a food's physical characteristics (a less-complex strategy) when they judge expected satiation. This trial was registered at clinicaltrials.gov as NCT01403753.

TITLE: A single dose of a non-steroidal anti-inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double-blind, placebo-controlled trial.ABSTRACT: To determine the incidence of severe pain after ureteric stent removal. To evaluate the efficacy of a single dose of a non-steroidal anti-inflammatory drug (NSAID) in preventing this complication.A prospective, randomised, double-blind, placebo-controlled trial was performed at our institution. Adults with an indwelling ureteric stent after ureteroscopy were randomised to receive either a single dose of placebo or an NSAID (rofecoxib 50 mg) before ureteric stent removal. Pain was measured using a visual analogue scale (VAS) just before and 24 h after stent removal Pain medication use after ureteric stent removal was measured using morphine equivalents.In all, 22 patients were enrolled and randomised into the study before ending the study after interim analysis showed significant decrease in pain level in the NSAID group. The most common indication for ureteroscopy was urolithiasis (14 patients). The proportion of patients with severe pain (VAS score of ≥7) during the 24 h after ureteric stent removal was six of 11 (55%) in the placebo group and it was zero of 10 in the NSAID group (P < 0.01). There were no complications related to the use of rofecoxib.We found a 55% incidence of severe pain after ureteric stent removal. A single dose of a NSAID before stent removal prevents severe pain after ureteric stent removal.

TITLE: A randomized bilateral vehicle-controlled study of eflornithine cream combined with laser treatment versus laser treatment alone for facial hirsutism in women.ABSTRACT: Although there are a multitude of therapeutic modalities for removing unwanted facial hair in women, there is very little information on using the newer medical treatment approaches in combination. This study was designed to determine whether topical eflornithine can enhance the efficacy of laser hair removal.This was a randomized, double-blind, placebo-controlled, right-left comparison study of eflornithine cream combined with laser treatment versus laser alone for treating unwanted hair on the upper lip in women. All subjects underwent treatment to the entire upper lip with a long pulse alexandrite laser (10-40 ms pulse duration) at fluences of 7 to 40 J/cm(2). Laser treatments were performed every 4 weeks for up to 6 sessions. Each patient also applied either eflornithine or placebo cream twice daily to each side of the upper lip in a double-blinded manner. Subjects were evaluated for safety by recording adverse events and for efficacy via (1) investigator global scoring, (2) patient self assessment, and (3) hair count analysis.Both treatment modalities were well tolerated by the 31 evaluable patients. All 3 outcome measures showed significantly better results in favor of eflornithine plus laser versus laser treatment alone. At the end of the study, complete or almost complete hair removal was achieved in 29 of 31 (93.5%) of the eflornithine-laser-treated sites versus 21 of 31 (67.9%) for the placebo cream-laser-treated sites (P = .021, McNemar test). Statistically significant differences in favor of eflornithine were likewise demonstrated at the final assessment through blinded patient grading (13/31 patients [41.9%] thought that the eflornithine was superior to placebo, P = .029, Poisson regression) and hair count analysis (P < .01, paired t test).This is a single-center study that did not determine whether the differences noted above last beyond 6 months.On the basis of both investigator and patient assessments and hair count analysis, we have demonstrated that the addition of eflornithine to laser hair removal results in a more rapid and complete reduction of unwanted facial hair in women when the combination is used for up to 6 months.

TITLE: Beneficial effects of a three-month structured exercise training program on cardiopulmonary functional capacity in young women with polycystic ovary syndrome.ABSTRACT: Polycystic ovary syndrome (PCOS) is an endocrine disease closely related to several risk factors for cardiovascular disease. An impaired cardiopulmonary functional capacity was previously demonstrated in PCOS women. No data regarding the effects of a structured exercise training (ET) program on cardiopulmonary functional capacity in PCOS women are available.Our objective was to evaluate the effects of a 3-month ET program on cardiopulmonary functional capacity in young PCOS women.A prospective baseline-randomized clinical study was conducted at the University "Federico II" of Naples, School of Medicine (Italy).Ninety young overweight PCOS women were enrolled.Ninety young PCOS women were randomly subdivided into two groups, each composed of 45 subjects. The PCOS-T (trained) group underwent a 3-month structured ET program, whereas the PCOS-UnT (untrained) group did not. Hormonal and metabolic profiles and cardiopulmonary and exercise parameters were evaluated.After 3-month ET, PCOS-T showed a significant improvement in peak oxygen consumption (+35.4%; P<0.001) and in maximal workload (+37.2%; P<0.001). In PCOS-T we also observed a significant reduction in body mass index (-4.5%; P<0.001) and in C-reactive protein (-10%; P<0.001), and a significant (P<0.001) improvement in insulin sensitivity indexes. After 3 months, no changes were observed in PCOS-UnT.A 3-month structured ET program improves cardiopulmonary functional capacity in young PCOS women.

TITLE: Exercise performance during losartan- or atenolol-based treatment in hypertensive patients with electrocardiographic left ventricular hypertrophy (a LIFE substudy).ABSTRACT: The objective of the study was to assess the influence of left ventricular (LV) hypertrophy regression on exercise capacity in hypertensive patients. Doppler echocardiography was performed at rest and during exercise in 51 patients with electrocardiographic LV hypertrophy before and after 1 year of randomized blinded losartan- or atenolol-based antihypertensive treatment. After 1 year, blood pressure was comparably reduced by 32/14 and 27/13 mmHg, respectively, in the losartan and atenolol groups, but the atenolol group had higher mean LV mass index (118 vs 103 g/m2) and lower LV ejection fraction (61% vs 67%) and midwall shortening (15.8% vs 16.8%) (all p<0.05). Resting diastolic Doppler indices remained unchanged and did not differ between the groups. Peak oxygen uptake during exercise was virtually unchanged after 1 year and did not differ between the groups in spite of a lower peak exercise heart rate in atenolol-treated patients. In multivariate analysis, higher peak oxygen uptake at 1 year was associated with lower body mass index, and higher systolic blood pressure and shorter isovolumic relaxation time at peak exercise (multiple R2 = 0.51, p<0.01), while age, gender, heart rate increase during exercise, reduction in LV mass and study treatment did not enter. In conclusion, reduction in blood pressure and LV mass induced by losartan or atenolol treatment was not accompanied by improved exercise capacity after 1 year. The results may be explained by persistent impairment of myocardial relaxation influencing exercise capacity.

TITLE: Efficacy of transcutaneous electrical nerve stimulation for pain relief in women undergoing office endometrial biopsy.ABSTRACT: To evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for decreasing pain related with office endometrial biopsy.In this prospective study, 65 women undergoing office endometrial biopsy were randomly allocated to receive 550 mg oral naproxen sodium plus active TENS (Group I, n = 33) or 550 mg oral naproxen sodium plus placebo TENS (Group II, n = 32). The intensity of pain perceived by the patients was measured using a 10-cm visual analog scale (VAS) before insertion of the speculum, when the cervix grasped, immediately after biopsy, and 15 min after the procedure. The effect of anxiety (Spielberger's state anxiety inventory) on pain scores was also investigated.There were no statistical significant differences between groups in age, weight, body mass index, gravidity, parity, education, and menopausal status (p > 0.05). The pain scores before insertion of the speculum, when the cervix grasped, and immediately after biopsy were similar in both groups (p > 0.05). But at 15 min after the procedure, there was a significant reduction of the mean VAS pain score in naproxen sodium plus TENS group, compared with the naproxen sodium plus placebo TENS group (0.14 ± 0.47, 1.44 ± 1.37, respectively, p < 0.0001). The mean anxiety scores were 48.19 ± 6.71 and 45.85 ± 6.22 in Group I and Group II, respectively. We did not find any significant correlation between anxiety and VAS pain scores (p > 0.05).TENS appears to be successful in decreasing pain only after the procedure undergoing office endometrial biopsy. It can be used as a simple, cheap, safe, and effective pain relief method.

TITLE: Prospective randomized trial of multiple micronutrients in subfertile women undergoing ovulation induction: a pilot study.ABSTRACT: This study investigated whether subfertile women undergoing ovulation induction using standard treatment regimens with clomiphene citrate/gonadotrophins have higher pregnancy rates when on an adjuvant multiple micronutrient (MMN) nutritional supplement compared with folic acid alone. A prospective randomized controlled trial was conducted in a teaching-hospital fertility clinic on 58 subfertile women, of which 56 women completed the study. Women undergoing ovulation induction were allocated to either receive adjuvant MMN supplementation or folic acid. Clinical pregnancy rates and blood nutrient concentrations were assessed after the third treatment attempt or as soon as the women achieved pregnancy. Using intention-to-treat analysis, it was observed that women on adjuvant MMN supplementation had a significantly higher cumulative clinical pregnancy rate (66.7%) compared with those on folic acid (39.3%; P = 0.013). The ongoing pregnancy rate in women on MMN supplementation was 60.0% versus 25.0% (P < 0.02) in the folic-acid group. Further, women who were on MMN supplementation had significantly fewer attempts to achieve pregnancy compared with women on folic acid (P < 0.001). The results of this pilot study suggest that women who take adjuvant MMN supplementation during ovulation induction have a higher chance of pregnancy compared with women on folic acid.

TITLE: The relationship, structure and profiles of schizophrenia measurements: a post-hoc analysis of the baseline measures from a randomized clinical trial.ABSTRACT: To fully assess the various dimensions affected by schizophrenia, clinical trials often include multiple scales measuring various symptom profiles, cognition, quality of life, subjective well-being, and functional impairment. In this exploratory study, we characterized the relationships among six clinical, functional, cognitive, and quality-of-life measures, identifying a parsimonious set of measurements.We used baseline data from a randomized, multicenter study of patients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder who were experiencing an acute symptom exacerbation (n = 628) to examine the relationship among several outcome measures. These measures included the Positive and Negative Syndrome Scale (PANSS), Montgomery-Asberg Depression Rating Scale (MADRS), Brief Assessment of Cognition in Schizophrenia Symbol Coding Test, Subjective Well-being Under Neuroleptics Scale Short Form (SWN-K), Schizophrenia Objective Functioning Instrument (SOFI), and Quality of Life Scale (QLS). Three analytic approaches were used: 1) path analysis; 2) factor analysis; and 3) categorical latent variable analysis. In the optimal path model, the SWN-K was selected as the final outcome, while the SOFI mediated the effect of the exogenous variables (PANSS, MADRS) on the QLS.The overall model explained 47% of variance in QLS and 17% of the variance in SOFI, but only 15% in SWN-K. Factor analysis suggested four factors: "Functioning," "Daily Living," "Depression," and "Psychopathology." A strong positive correlation was observed between the SOFI and QLS (r = 0.669), and both the QLS and SOFI loaded on the "Functioning" factor, suggesting redundancy between these scales. The measurement profiles from the categorical latent variable analysis showed significant variation in functioning and quality of life despite similar levels of psychopathology.Researchers should consider collecting PANSS, SOFI, and SWN-K in their trials. This would allow a broad spectrum of assessments that would have the ability to capture a wide range of treatment outcomes and allow for a rich characterization of the subgroups involved. Additional research is needed to identify the critical cognitive measures.TRIALS REGISTRATION BACKGROUNDPredicting Response to Risperidone Treatment Through Identification of Early-onset of Antipsychotic Drug Action in SchizophreniaClinicalTrials.gov identifier: NCT00337662; http://www.clinicaltrials.gov/

TITLE: The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease.ABSTRACT: Tobacco use and other cardiovascular risk factors often accompany chronic obstructive pulmonary disease (COPD). This study derived and validated the Summit Score to predict mortality in people with COPD and cardiovascular risks.SUMMIT trial subjects (N=16,485) ages 40-80 years with COPD were randomly assigned 50%/50% to derivation (N=8181) and internal validation (N=8304). Three external COPD validations from Intermountain Healthcare included outpatients with cardiovascular risks (N=9251), outpatients without cardiovascular risks (N=8551), and inpatients (N=26,170). Cox regression evaluated 40 predictors of all-cause mortality. SUMMIT treatments including combined fluticasone furoate (FF) 100μg/vilanterol 25μg (VI) were not included in the score.Mortality predictors were FEV, heart rate, systolic blood pressure, body mass index, age, smoking pack-years, prior COPD hospitalizations, myocardial infarction, heart failure, diabetes, anti-thrombotics, anti-arrhythmics, and xanthines. Combined in the Summit Score (derivation: c=0.668), quartile 4 vs 1 had HR=4.43 in SUMMIT validation (p<0.001, 95% CI=3.27, 6.01, c=0.662) and HR=8.15 in Intermountain cardiovascular risk COPD outpatients (p<0.001, 95% CI=5.86, 11.34, c=0.736), and strongly predicted mortality in the other Intermountain COPD populations. Among all SUMMIT subjects with scores 14-19, FF 100μg/VI 25μg vs placebo had HR=0.76 (p=0.0158, 95% CI=0.61, 0.95), but FF 100μg/VI 25μg was not different from placebo for scores <14 or >19.In this post hoc analysis of SUMMIT trial data, the Summit Score was derived and validated in multiple Intermountain COPD populations. The score was used to identify a subpopulation in which mortality risk was lower for FF 100μg/VI 25μg treatment.The SUMMIT trial is registered at ClinicalTrials.gov as number NCT01313676.

TITLE: Effect of direct intramyocardial autologous stem cell grafting in the sub-acute phase after myocardial infarction.ABSTRACT: To assess the efficacy and safety of intramyocardial autologous bone marrow mononuclear stem cells (BMMNC) grafting combined with coronary artery bypass grafting (CABG) on ventricular remodeling and global and regional wall motion after acute transmural myocardial infarction (AMI).Randomized controlled trial including 20 patients with non-revascularized transmural AMI, left ventricular ejection fraction (LVEF) lower than 50% and surgical indication for CABG. The stem cell group was treated with BMMNC grafting by direct intramyocardial injection between the 10th and 15th days after AMI (subacute phase) combined with CABG under cardiopulmonary bypass; the control group was only treated with CABG. Magnetic resonance imaging with gadolinium and stress echocardiography were performed presurgery and 9 months postsurgery.Seventeen patients completed the follow-up. The baseline characteristics of both groups were homogeneous. No significant differences were found in the increase in LVEF (control: 6.99±4.60, cells: 7.47±6.61, P=0.876) or in the decrease in global (control: 0.28±0.39, cells: 0.22±0.28, P=0.759) or regional (control: 0.52±0.38, cells: 0.74±0.60, P=0.415) wall motion indices between the control and stem cell groups of AMI patients. No differences were found in the recovered non-viable segments (control: 1.29±1.11, cells: 2.50±1.41, P=0.091) or in the decrease in end-diastolic (control: 14.05±19.72, cells: 18.40±29.89, P=0.725) or end-systolic (control: 15.42±13.93, cells: 23.06±25.03, P=0.442) volumes. No complications from stem cell grafting were observed.The results from our study reported herein suggest that intramyocardial BMMNC administration during CABG in patients with AMI causes no medium- to long-term improvement in ventricular remodeling.

TITLE: Nintedanib in Japanese patients with idiopathic pulmonary fibrosis: A subgroup analysis of the INPULSIS® randomized trials.ABSTRACT: Idiopathic pulmonary fibrosis (IPF) is a specific form of chronic, progressive fibrosing interstitial pneumonia. Nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC) compared with placebo in patients with IPF in two replicate trials (INPULSIS®). We examined the efficacy and safety of nintedanib in Japanese patients.We conducted pre-specified subgroup analyses of the annual rate of decline in FVC, time to first acute exacerbation (AE), change from baseline in St George's Respiratory Questionnaire (SGRQ) total score and safety using pooled data from the INPULSIS® trials for Japanese patients.In the overall population, 76 of 638 and 50 of 423 patients in the nintedanib and placebo groups, respectively, were Japanese. Results in Japanese patients were consistent with those in the overall population. In Japanese patients, the adjusted annual rate of decline in FVC was -135.9 mL/year in the nintedanib group and -267.7 mL/year in the placebo group (difference (95% CI): 131.9 (50.7, 213.1) mL/year); the hazard ratio for the time to first AE was 0.25 (0.06, 1.02); and the adjusted mean change from baseline in SGRQ total score at week 52 was 5.81 in the nintedanib group and 9.68 in the placebo group (difference: -3.87 (-8.51, 0.76)). Diarrhoea and liver-related adverse events were the most common events in the nintedanib group, but were reversible following dose reduction, drug interruption or symptomatic therapy.The present results indicate that the efficacy and safety of nintedanib in Japanese patients are comparable with those in the overall population.

TITLE: Determinants of delay in timely treatment seeking for diarrheal diseases among mothers with under-five children in central Ethiopia: A case control study.ABSTRACT: Delays in seeking timely appropriate care contributes to a large number of deaths from diarrhea in children. This study aimed to identify determinants of delays in seeking timely treatment by mothers/caregivers of under-five children with diarrheal diseases.We used an unmatched case-control study from February-March 2017 among 316 children: 158 cases and 158 controls. Cases were mothers/caregivers with under-five children who had signs/symptoms of diarrhea and sought treatment after 24 hours onset of symptom. Controls sought treatment within 24 hours. Field workers collected data using a pre-tested standardized questionnaire. Multivariate logistic regression was conducted to identify determinants of delay in timely diarrhea treatment seeking. Statistical significance was declared by using a p-value<0.05 and 95% of confidence interval (CI) for an adjusted-odds ratio (AOR).The determinants of delay in timely treatment seeking of mothers/caregivers of under-five children with diarrheal diseases were children <24months (AOR = 1.9,95%CI:1.1-3.4); fail to attend school (AOR = 2.4, 95%CI:1.2-4.6); being female children (AOR = 1.7,95%CI:1.05-2.9); preferring government health facility for the treatment of children with diarrheal diseases (AOR = 2.9, 95%CI, 1.3-6.7); lack of past history taking children to health facility and lack of counseling (AOR = 4.8, 95%CI:2.0-12.1); being in the15-25 years age (AOR = 1.7, 95%CI:1.1-3.0) and taking children to a health facility as a first response to diarrhea (AOR = 0.1, 95%CI:0.01-0.8).Age of the child, maternal age, and disease related determinants were determinants for seeking timely treatment to diarrheal diseases. Providing skilled based health education and counseling to mothers/caregivers on seeking timely treatment and taking children with diarrheal diseases to a health facility as a first response to diarrhea is a paramount intervention to reduce morbidity and mortality of children.

TITLE: Effects of low- and high-pressure carbon dioxide pneumoperitoneum on intracranial pressure during laparoscopic cholecystectomy.ABSTRACT: Laparoscopic surgeries are a risk factor for raised intracranial **pressure and neurological complications. Even though rare, the consequences may be severe.One hundred and one patients of laparoscopic cholecystectomy were enrolled and were randomized into two groups: low-pressure 8 mm Hg (Group A) and high-pressure 14 mm Hg (Group B) carbon dioxide pneumoperitoneum during surgery. Fifty patients were in group A and 51 patients were in group B. Intracranial pressure was measured by measuring the optic nerve sheath diameter (ONSD) using ultrasound examination. Baseline ONSD was recorded followed by ONSD recording at various intervals: at the induction of anesthesia; 30 min, 45 min, at the end of surgery; and 30 min post surgery.The groups were comparable in terms of demographics and comorbidities. The mean age of group A was 45 years and for group B it was 45.75 years. Most common indication for surgery was symptomatic gall stone disease. Baseline ONSD in group A was 0.427 ± 0.0459 mm, whereas it was 0.412 ± 0.0412 mm in group B. There was a significant rise of ONSD (p < 0.05) 30 min after induction of pneumoperitoneum and up to 30 min post anesthesia. In the low-pressure group 7 (14%) patients had a significant rise of ICP, whereas in the high-pressure group 20 (39%) patients had a significant rise of ICP (p < 0.05).High-pressure pneumoperitoneum causes significant rise in intracranial pressure in comparison to low-pressure pneumoperitoneum during laparoscopic cholecystectomy, which can be monitored by ONSD measurement by ultrasound examination and is totally non-invasive.

TITLE: Efficacy of oxycodone in intravenous patient-controlled analgesia with different infusion modes after laparoscopic radical surgery of cervical cancer a prospective, randomized, double-blind study.ABSTRACT: The aim of this study was to compare the analgesic and adverse effects of oxycodone with 3 different infusion modes on postoperative pain after laparoscopic radical surgery of cervical cancer.Ninety patients undergoing laparoscopic radical surgery of cervical cancer were randomly divided into 3 groups: Group A (continuous infusion with 0.01 mg/kg/h and a bolus dose with 0.03 mg/kg), Group B (a bolus dose with 0.03 mg/kg) and Group C (PCA was administered as a time-scheduled decremental continuous infusion based on lean body mass). A blinded observer recorded Visual Analogue Scale (VAS), Ramsay sedation score (RSS), infused cumulative dose of oxycodone and side effects at 1, 6, 12, 24, and 48 hours postoperatively, and satisfaction during the postoperative 48 hours.There were significant differences in the VAS pain score when resting or coughing among 3 groups at 1, 6 and 48 hours postoperatively (P <.05). VAS was significantly higher in Group B than in Group A and C until postoperative 1, 6, and 48 hours (P <.05). There were significant differences in cumulative PCA dose among the 3 groups at 1 and 48 hours postoperatively (P <.05). Group C showed significantly less amount of cumulative PCA dose compared to other 2 groups at 1 hour, whereas cumulative PCA dose of Group A at 48 hours was significantly more than other 2 groups (P <.05). There were no significant differences in postoperative nausea and vomiting, FAS, muscle chilling score and RSS among 3 groups at 1, 6, 12, 24 and 48 hours postoperatively. In addition, there was no difference in overall satisfaction during 48 hours postoperatively among 3 groups.Oxycodone provides significant analgesic effect in 3 different infusion modes over 48 hours after laparoscopic radical surgery of cervical cancer, and a time-scheduled decremental continuous infusion of oxycodone can become a better choice for patients after surgery of cervical cancer.

TITLE: Efficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial.ABSTRACT: Multiple sclerosis (MS) is a chronic immune mediated disease and the progressive phase appears to have significant neurodegenerative mechanisms. The classification of the course of progressive MS (PMS) has been re-organized into categories of active vs. not active inflammatory disease and the presence vs. absence of gradual disease progression. Clinical trial experience to date in PMS with anti-inflammatory medications has shown limited effect. Andrographolide is a new class of anti-inflammatory agent, that has been proposed as a potential drug for autoimmune disorders, including MS. In the present trial, we perform an exploratory pilot study on the efficacy and safety of andrographolide (AP) compared to placebo in not active PMS.A pilot clinical trial using 140 mg oral AP or placebo twice daily for 24 months in patients with not active primary or secondary progressive MS was conducted. The primary efficacy endpoint was the mean percentage brain volume change (mPBVC). Secondary efficacy endpoints included 3-month confirmed disability progression (3-CDP) and mean EDSS change.Forty-four patients were randomized: 23 were assigned to the AP group, and 21 were assigned to the placebo group. The median baseline EDSS of both groups was 6.0. Annualized mPBVC was - 0.679% for the AP group and - 1.069% for the placebo group (mean difference: -0.39; 95% CI [- 0.836-0.055], p = 0.08, relative reduction: 36.5%). In the AP group, 30% had 3-CDP compared to 41% in the placebo group (HR: 0.596; 95% CI [0.200-1.777], p = 0.06). The mean EDSS change was - 0.025 in the AP group and + 0.352 in the placebo group (mean difference: 0.63, p = 0.042). Adverse events related to AP were mild rash and dysgeusia.AP was well tolerated and showed a potential effect in reducing brain atrophy and disability progression, that need to be further evaluated in a larger clinical trial.ClinicalTrials.gov NCT02273635 retrospectively registered on October 24th, 2014.

TITLE: Is it necessary to insert a nasobiliary drainage tube routinely after endoscopic clearance of the common bile duct in patients with choledocholithiasis-induced cholangitis? A prospective, randomized trial.ABSTRACT: Little is known about whether a routinely inserted endoscopic nasobiliary drainage (ENBD) tube improves the clinical course in patients with choledocholithiasis-induced acute cholangitis after clearance of choledocholithiasis.The aim of this study was to investigate the need for ENBD on the clinical outcomes of patients with acute cholangitis undergoing endoscopic clearance of common bile duct (CBD) stones.Prospective, randomized study.Tertiary referral center.A total of 104 patients with choledocholithiasis-induced acute cholangitis who underwent primary endoscopic treatment were compared according to insertion of an ENBD tube (51 in the ENBD group and 53 in the no-ENBD group).Insertion of an ENBD tube after clearance of CBD stones.Recurrence of cholangitis and length of hospital stay after clearance of CBD stones.Baseline clinical characteristics were similar between both groups. There were no significant differences in the recurrence rate of cholangitis at 24 weeks (3.9% for the ENBD group vs 3.8% for the no-ENBD group at 24 weeks; P = .99) and length of hospital stay (7.9 days [standard error = 1.2] for the ENBD group vs 7.9 days [standard error = 0.7] for the no-ENBD group; P = .98). However, procedure time was longer (26.2 [SE = 1.8] minutes vs 22.7 [SE = 1.0] minutes, respectively; P = .01) and the discomfort score was higher (4.9 [SE = 0.4] vs 2.8 [SE = 0.3], respectively; P = .02) in the ENBD group than in the no-ENBD group.Single-center study.A routinely inserted ENBD tube did not improve the clinical course, despite patients having to endure increased procedure time and discomfort, and the insertion would therefore be unnecessary.

TITLE: Prognosis of Behcet's syndrome among men with mucocutaneous involvement at disease onset: long-term outcome of patients enrolled in a controlled trial.ABSTRACT: To assess the influence of being free of major organ involvement during the early years of the disease on the prognosis of men with Behçet's syndrome (BS).Ninety-six men with BS, who had only active mucocutaneous manifestations when entering a controlled trial of thalidomide mean (s.d.) 11.7 (0.8) years ago, were re-evaluated for the use of immunosuppressives as an indication of major organ involvement during the post-trial period.Outcome information was obtained in 91 (95%) patients. Thirty-nine (43%) patients had to use immunosuppressives during the post-trial period. Immunosuppressive use was significantly more frequent among patients developing BS at younger age (76%; <or=24 years) than older age (30%; >or=25 years). Developing BS at young age (OR = 6.3; 95% CI 2.09, 19.04) and not using colchicine during the post-trial period (OR = 3.860; 95% CI 1.484, 10.034) were risk factors for immunosuppressive use. However, 82% of the patients using colchicine had onset during old age. Colchicine showed a significant effect in decreasing the use of immunosuppressives only among patients of old age at onset (Fisher's exact test = 5.026; P = 0.031) in the subgroup analysis. Eye disease (18 patients) and vascular involvement (14 patients) were the most frequent indications for immunosuppressive use.Being free of major organ involvement during the early years of BS does not indicate a mild prognosis for men developing BS at young age. Whether colchicine will reduce the need for immunosuppressive use among men developing BS at old age awaits formal studies.

TITLE: Biomarkers for oxidative stress and organ injury during Transnasal Humidified Rapid-Insufflation Ventilatory Exchange compared to mechanical ventilation in adults undergoing microlaryngoscopy: A randomised controlled study.ABSTRACT: Apnoeic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) during general anaesthesia prolongs the safe apnoeic period. However, there is a gap of knowledge how THRIVE-induced hyperoxia and hypercapnia impact vital organs. The primary aim of this randomised controlled trial was to characterise oxidative stress and, secondary, vital organ function biomarkers during THRIVE compared to mechanical ventilation (MV).Thirty adult patients, American Society of Anesthesiologists (ASA) 1-2, undergoing short laryngeal surgery under general anaesthesia were randomised to THRIVE, F O 1.0, 70 L min during apnoea or MV. Blood biomarkers for oxidative stress, malondialdehyde and TAC and vital organ function were collected (A) preoperatively, (B) at procedure completion and (C) at PACU discharge.Mean apnoea time was 17.9 (4.8) min and intubation to end-of-surgery time was 28.1 (12.8) min in the THRIVE and MV group, respectively. Malondialdehyde increased from 11.2 (3.1) to 12.7 (3.1) µM (P = .02) and from 9.5 (2.2) to 11.6 (2.6) µM (P = .003) (A to C) in the THRIVE and MV group, respectively. S100B increased from 0.05 (0.02) to 0.06 (0.02) µg L (P = .005) (A to C) in the THRIVE group. No increase in TAC, CRP, leukocyte count, troponin-T, NTproBNP, creatinine, eGFRcrea or NSE was demonstrated during THRIVE.While THRIVE and MV was associated with increased oxidative stress, we found no change in cardiac, inflammation or kidney biomarkers during THRIVE. Further evaluation of stress and inflammatory response and cerebral and cardiac function during THRIVE is needed.

TITLE: Patient-centred innovation for multimorbidity care: a mixed-methods, randomised trial and qualitative study of the patients' experience.ABSTRACT: Patient-centred interventions to help patients with multimorbidity have had mixed results.To assess the effectiveness of a provider-created, patient-centred, multi-provider case conference with follow-up, and understand under what circumstances it worked, and did not work.Mixed-methods design with a pragmatic randomised trial and qualitative study, involving nine urban primary care sites in Ontario, Canada.Patients aged 18-80 years with ≥3 chronic conditions were referred to the Telemedicine IMPACT Plus intervention; a nurse and patient planned a multi-provider case conference during which a care plan could be created. The patients were randomised into an intervention or control group. Two subgroup analyses and a fidelity assessment were conducted, with the primary outcomes at 4 months being self-management and self-efficacy. Secondary outcomes were mental and physical health status, quality of life, and health behaviours. A thematic analysis explored the patients' experiences of the intervention.A total of 86 patients in the intervention group and 77 in the control group showed no differences, except that the intervention improved mental health status in the subgroup with an annual income of ≥C$50 000 (β-coefficient 11.003, = 0.006). More providers and follow-up hours were associated with poorer outcomes. Five themes were identified in the qualitative study: valuing the team, patients feeling supported, receiving a follow-up plan, being offered new and helpful additions to their treatment regimen, and experiencing positive outcomes.Overall, the intervention showed improvements only for patients who had an annual income of ≥C$50 000, implying a need to address the costs of intervention components not covered by existing health policies. Findings suggest a need to optimise team composition by revising the number and type of providers according to patient preferences and to enhance the hours of nurse follow-up to better support the patient in carrying out the case conference's recommendations.

TITLE: Impact of tylosin phosphate and distillers dried grains with solubles on energy and nutrient digestibility and flow through the gastrointestinal tract in growing pigs.ABSTRACT: The objective of this study was to evaluate the impact of tylosin phosphate (TP) on energy and nutrient digestibility and flow through the gastrointestinal tract in growing pigs fed corn-soybean meal or corn-soybean meal-distillers dried grains with solubles (DDGS) based diets. Eighteen barrows (initial BW = 32.6 ± 1.2 kg) were surgically fitted with a T-cannula in the distal ileum and allotted to a Youden square design with 6 diets and 3 replicate periods. Treatments were arranged in a 2 × 2 factorial: TP (0 vs. 44 mg/kg) and DDGS (0 vs. 25%). Two N-free dietary treatments (0 vs. 44 mg/kg TP) were also included for determining basal ileal endogenous AA losses (IAAend) and the effect of TP on basal IAAend. Replicate periods included 4 d of adaptation to treatments and 2 sampling periods. Fecal collection occurred on d 5 and 6 and ileal digesta collection occurred on d 7 and 8 for sampling period 1 whereas sampling period 2 included fecal collection on d 11 and 12 and ileal digesta collection on d 13 and 14. Apparent ileal digestibility (AID) and apparent total tract digestibility (ATTD) were calculated for DM, energy, and NDF. The AID and standardized ileal digestibility (SID) of AA were calculated. Inclusion of DDGS reduced AID (68.0 vs. 72.8%; P < 0.001) and ATTD (79.9 vs. 85.0%; P < 0.001) of energy. There were no effects of TP on energy digestibility. The DDGS inclusion increased the amount of GE (1.47 vs. 1.18 Mcal/kg DMI; P < 0.001) and NDF (94 vs. 60 g/kg DMI; P < 0.001) remaining at the terminal ileum; however, hindgut disappearance of energy (0.55 vs. 0.53 Mcal/kg DMI) and NDF (13 vs. 15 g/kg DMI) was similar between the corn-soybean meal-DDGS and corn-soybean meal based diets. There were no effects of TP on basal IAAend; therefore, SID AA values were calculated using means of the 2 N-free diets. The SID of Lys (79.6 vs. 84.1%; P < 0.001) and all other indispensible AA, except Leu, was lower in the DDGS diets. Inclusion of TP did not influence SID of AA. In conclusion, under the conditions of this experiment, TP did not affect digestibility of AA or the digestibility and gastrointestinal tract flow of energy and the inclusion of DDGS did not affect the response to TP.

TITLE: Nutrition, Hygiene and Stimulation Education for Impoverished Mothers in Rural Uganda: Effect on Maternal Depression Symptoms and Their Associations to Child Development Outcomes.ABSTRACT: Optimal nutrition improves child development, and impaired development is associated with maternal depression symptoms, in particular in low resource settings. In this follow-up of an open cluster-randomized education trial, we examined its effects among mothers in rural Uganda on their depression symptoms and the association of these symptoms to child development. The education comprised complementary feeding, stimulation, and hygiene. We assessed 77 intervention mothers and 78 controls using Beck Depression Inventory-II (BDI-II) and Center for Epidemiologic Studies Depression Scale (CES-D) scores. Child development was assessed with Bayley Scales of Infant and Toddler Development-III (BSID-III) composite scores for cognitive, language and motor development. Compared to controls, the intervention reduced depression symptoms' scores with mean (95% CI) differences: -8.26 (-11.49 to -1.13, = 0.0001) and -6.54; (-8.69 to -2.99, = 0.004) for BDI II at 20-24 and 36 months, respectively. Similar results were obtained with CES-D. There was a negative association of BDI-II scores and BSID-III cognitive and language scores at 20-24 ( = 0.01 and 0.008, respectively) and 36 months ( = 0.017 and 0.001, respectively). CES-D associations with BSID-III cognitive and language scores showed similar trends. BSID-III motor scores were associated with depression scores at 36 months for both BDI-II and CES-D ( = 0.043 and 0.028, respectively). In conclusion, the group education was associated with reduced maternal depression scores. Moreover, the depression scores were inversely associated with child cognitive and language development outcomes.

TITLE: The Influences of Chromium Supplementation on Metabolic Status in Patients with Type 2 Diabetes Mellitus and Coronary Heart Disease.ABSTRACT: This investigation was conducted to determine the effects of chromium supplementation on metabolic status in diabetic patients with coronary heart disease (CHD). This randomized, double-blind, placebo-controlled trial was performed in 64 diabetic patients with CHD between October 2017 and January 2018. Patients were randomly divided into two groups to obtain either 200 μg chromium (n = 32) or placebo (n = 32) for 12 weeks. Chromium supplementation significantly reduced body weight (- 0.9 ± 1.6 vs. + 0.1 ± 0.8 kg, P = 0.001), BMI (- 0.4 ± 0.7 vs. + 0.1 ± 0.3 kg/m, P = 0.002), fasting glucose (β - 11.03 mg/dL; 95% CI, - 18.97, - 3.09; P = 0.007), insulin (β - 1.33 μIU/mL; 95% CI, - 1.90, - 0.76; P < 0.001), and insulin resistance (β - 0.44; 95% CI, - 0.62, - 0.25; P < 0.001) and significantly increased insulin sensitivity (β 0.007; 95% CI, 0.003, 0.01; P < 0.001) compared with the placebo. In addition, taking chromium led to a significant reduction in serum high-sensitivity C-reactive protein (hs-CRP) (β - 0.49 mg/L; 95% CI, - 0.91, - 0.06; P = 0.02) and plasma malondialdehyde (MDA) levels (β - 0.22 μmol/L; 95% CI, - 0.35, - 0.10; P = 0.001); also, a significant rise in total antioxidant capacity (TAC) (β 84.54 mmol/L; 95% CI, 31.05, 138.02; P = 0.002) was observed in comparison with placebo. Additionally, chromium administration significantly reduced diastolic blood pressure (DBP) (β - 5.01 mmHg; 95% CI, - 9.04, - 0.97; P = 0.01) compared with the placebo. Overall, the 12-week supplementation of chromium to diabetic patients with CHD had beneficial impacts on weight, BMI, glycemic control, hs-CRP, TAC, MDA, and DBP.Trial Registration www.irct.ir: http://www.irct.ir: IRCT20170513033941N30.

TITLE: Effect of a balance-training programme on postural balance, aerobic capacity and frequency of falls in women with osteoporosis: A randomized controlled trial.ABSTRACT: To investigate the effect of a 12-month complex balance-training programme on static and dynamic postural balance, aerobic capacity and frequency of falls in women with established osteoporosis.Randomized controlled trial in which the intervention group was assigned a 12-month exercise programme (3 times a week for 30 min) and the control group had no intervention.A total of 100 osteoporotic women with at least one previous fracture.Performance-based Timed Up and Go (TUG), Berg Balance Scale (BBS) and stabilometric platform tests were used to evaluate balance. Aerobic capacity was measured by bicycle ergometry. Frequency of falls was assessed using a falls diary.After 1 year, there was a statistically significant difference between the improvement achieved in the intervention and control groups on the performance-based TUG, BBS and stabilometric platform tests (p < 0.05). Mean metabolic equivalent (MET) value decreased in the intervention group, from 4.91 to 3.82 (a significant difference from the change achieved in the control group; p = 0.05). Relative risk of falls was 0.534 at 1 year (p = 0.17).The 12-month balance-training programme significantly improved postural balance and increased aerobic capacity in women with established osteoporosis.

TITLE: Exercise and postprandial lipemia: effects on vascular health in inactive adults.ABSTRACT: There is evidence to suggest that postprandial lipemia are is linked to the impairment of endothelial function, which is characterized by an imbalance between the actions of vasodilators and vasoconstrictors. The aim of this study was to determine the effects of a 12-week high-intensity training (HIT) and moderate continuous training (MCT) protocol on postprandial lipemia, vascular function and arterial stiffness in inactive adults after high-fat meal (HFM) ingestion.A randomized clinical trial was conducted in 20 healthy, inactive adults (31.6 ± 7.1 years). Participants followed the two exercise protocols for 12 weeks. To induce a state of postprandial lipemia (PPL), all subjects received a HFM. Endothelial function was measured using flow-mediated vasodilation (FMD), normalized brachial artery FMD (nFMD), aortic pulse wave velocity (PWV) and augmentation index (AIx). Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-c), triglycerides and glucose were also measured.The effects of a HFM were evaluated in a fasted state and 60, 120, 180, and 240 min postprandially. A significant decrease in serum glucose between 0 min (fasted state) and 120 min postprandially was found in the HIT group (P = 0.035). Likewise, FMD (%) was significantly different between the fasted state and 60 min after a HFM in the HIT group (P = 0.042). The total cholesterol response expressed as area under curve (AUC) was lower following HIT than following MCT, but no significant differences were observed (8%, P > 0.05). Similarly, triglycerides AUC was also lower after HIT compared with MCT, which trended towards significance (24%, P = 0.076). The AUC for the glucose response was significantly lower following HIT than MCT (10%, P = 0.008). FMD and nFMD AUC were significantly higher following HIT than following MCT (46.9%, P = 0.021 and 67.3%, P = 0.009, respectively). PWV AUC did not differ following between the two exercise groups (2.3%, P > 0.05).Supervised exercise training mitigates endothelial dysfunction and glucose response induced by PPL. Exercise intensity plays an important role in these protective effects, and medium-term HIT may be more effective than MCT in reducing postprandial glucose levels and attenuating vascular impairment.ClinicalTrials.gov ID: NCT02738385 Date of registration: April 14, 2016.

TITLE: Sequential non-invasive following short-term invasive mechanical ventilation in the treatment of tuberculosis with respiratory failure: a randomized controlled study.ABSTRACT: Invasive and non-invasive mechanical ventilation (MV) have been combined as sequential MV in the treatment of respiratory failure. However, the effectiveness remains unclear. Here, we performed a randomized controlled study to assess the efficacy and safety of sequential MV in the treatment of tuberculosis with respiratory failure.Forty-four tuberculosis patients diagnosed with respiratory failure were randomly divided into sequential MV group (n = 24) and conventional MV group (n = 20). Initially, the patients in both groups received invasive positive pressure ventilation. When the patients' conditions were relieved, the ventilation modality in sequential MV group was switched to oronasal face mask continuous positive airway pressure until weaning.After treatment, the patients in sequential MV group had similar respiratory rate, heart rate, oxygenation index, alveolo-arterial oxygen partial pressure difference (A-aDO), blood pH, PaCO to those in conventional MV group (all P value > 0.05). There was no significant difference in ventilation time and ICU stay between the two groups (P > 0.05), but sequential MV group significantly reduced the time of invasive ventilation (mean difference (MD): - 36.2 h, 95% confidence interval (CI) - 53.6, - 18.8 h, P < 0.001). Sequential MV group also reduced the incidence of ventilator-associated pneumonia (VAP; relative risk (RR): 0.44, 95% CI 0.24, 0.83, P = 0.006) and atelectasis (RR:0.49, 95% CI 0.24,1.00, P = 0.040).Sequential MV was effective in treating tuberculosis with respiratory failure. It showed advantages in reducing invasive ventilation time and ventilator-associated adverse events.Chinese Clinical Trial Registry ChiCTR2000032311, April 21st, 2020.

TITLE: The effect of stoma size on weight loss after laparoscopic gastric bypass surgery: results of a blinded randomized controlled trial.ABSTRACT: To determine the effect of different stoma sizes on the percent excess weight loss (%EWL) following laparoscopic Roux-en-Y gastric bypass surgery (LRYGBP).Blinded randomized prospective controlled study in two American Society for Bariatric Surgeons-designated Centers of Excellence hospitals. Two hundred gastric bypass patients between January 2005 and September 2005 were prospectively randomized into two groups of 100 patients each in the operating room, after the induction of anesthesia. Patients underwent LRYGBP with different stapler sizes of 21 and 25 mm for gastrojejunal (GJ) anastomosis from January 2005 to September 2005. Postoperative %EWL following LRYGBP in both patient groups were calculated using a multivariable linear mixed-effects model with an unstructured covariance matrix and a logistic regression was used to measure clinical comorbidities.Applying multivariable mixed models and logistical regression, circular stapler size of 21 and 25 mm, which predicted the need for dilations (odds ratio = 0.489), did not predict weight loss. The only predictors of weight loss were male gender and higher initial weight (p < 0.001). Follow-up at 2 years in the 21- and 25-mm groups was 68% and 66%, respectively. Both groups had > 80% EWL at 2 years.The level of restriction or the presence of stenosis achieved by different circular stapler sizes does not have a significant causative role in weight loss.

TITLE: Management of Postoperative Pain after Elective Craniotomy: A Prospective Randomized Controlled Trial of a Neurosurgical Enhanced Recovery after Surgery (ERAS) Program.ABSTRACT: To prospectively evaluate the efficacy of a neurosurgical enhanced recovery after surgery (ERAS) protocol on the management of postoperative pain after elective craniotomies. This randomized controlled trial was conducted in the neurosurgical center of Tangdu Hospital (Fourth Military Medical University, Xi'an, China). A total of 129 patients undergoing craniotomies between October 2016 and July 2017 were enrolled in a randomized clinical trial comparing an ERAS protocol to a conventional postoperative care regimen. The primary outcome was the postoperative pain score assessed by a verbal numerical rating scale (NRS). Patients in the ERAS group had a significant reduction in their postoperative pain scores on POD 1 compared to patients in the control group (p < 0.05). More patients (n = 44, 68.8%) in the ERAS group experienced mild pain (NRS: 1 to 3) on POD1 compared with patients (n = 23, 35.4%) in the control group (p < 0.05). A further reduction in pain scores was also observed on POD 2 and maintained on POD 3 in the ERAS group compared with that in the control group. In addition, the median postoperative length of hospital stay was significantly decreased with the incorporation of the ERAS protocol compared to controls (ERAS: 4 days, control: 7 days, P<0.001). The implementation of a neurosurgical ERAS protocol for elective craniotomy patients has significant benefits in alleviating postoperative pain and enhancing recovery leading to early discharge after surgery compared to conventional care. Further evaluation of this protocol in larger, multi-center studies is warranted.

TITLE: An Open, Randomized, Single-Center, Crossover Pharmacokinetic Study of Meropenem after Intraperitoneal and Intravenous Administration in Patients Receiving Automated Peritoneal Dialysis.ABSTRACT: The objective of this study was to determine the pharmacokinetic profile of meropenem in automated peritoneal dialysis (APD) patients. In 6 patients without peritonitis, a single dose of 0.5 g of meropenem was applied intraperitoneally (i.p.) or intravenously (i.v.) and concentrations in serum and dialysate were measured at specified intervals over 24 h with high-performance liquid chromatography-mass spectrometry. The mean maximum concentrations of meropenem in serum (Cmax) were 27.2 mg/liter (standard deviation [SD], ±6.9) and 10.1 mg/liter (SD, ±2.5) and in dialysate were 3.6 mg/liter (SD, ±2.3) and 185.8 mg/liter (SD, ±18.7) after i.v. and i.p. administrations, respectively. The mean areas under the curve from 0 to 24 (AUC0-24) of meropenem in serum were 173.5 mg · h/liter (SD, ±29.7) and 141.4 mg · h/liter (SD, ±37.5) (P = 0.046) and in dialysate were 42.6 mg · h/liter (SD, ±20.0) and 623.4 mg · h/liter (SD, ±84.1) (P = 0.028) after i.v. and i.p. administrations, respectively. The ratios for dialysate exposure over plasma exposure after i.v. and i.p. treatments were 0.2 (SD, ±0.1) and 4.6 (SD, ±0.9), respectively (P = 0.031). A mean target value of 40% T>MIC (time for which the free meropenem concentration exceeds the MIC) for clinically relevant pathogens with EUCAST susceptibility breakpoints of 2 mg/liter was reached in serum after i.p. and i.v. administrations and in dialysate after i.p. but not after i.v. administration. The present data indicate that low i.p. exposure limits the i.v. use of meropenem for PD-associated peritonitis. In contrast, i.p. administration not only results in superior concentrations in dialysate but also might be used to treat systemic infections.

TITLE: Association between Shammah Use and Oral Leukoplakia-like Lesions among Adult Males in Dawan Valley, Yemen.ABSTRACT: Shammah is a traditional form of snuff dipping tobacco (a smokeless tobacco form) that is commonly used in Yemen. Oral mucosal changes due to the use of shammah can usually be observed in the mucosal surfaces that the product touches. The aim of this study was to determine the association between shammah use and oral leukoplakia-like lesions. Other associated factors were also determined.A cross sectional study was conducted on 346 randomly selected adult males. Multi-stage random sampling was used to select the study location. After completing the structured questionnaire interviews, all the participants underwent clinical exanimation for screening of oral leukoplakia-like lesions Clinical features of oral leukoplakia-like lesion were characterized based on the grades of Axell et al (1976). Univariable logistic regression and multivariable logistic regression were used to assess the potential associated factors.Out of 346 male participants aged 18 years and older, 68 (19.7%) reported being current shammah users. The multivariable analysis revealed that age, non-formal or primary level of education, former shammah user, current shammah user, and frequency of shammah use per day were statistically associated with the presence of oral leukoplakia-like lesions [Adjusted odds ratio (AOR) = 1.03; 95% confidence interval (CI) : 1.01, 1.06; P= 0.006], (AOR= 8.65; 95% CI: 2.81, 26.57; P= 0.001), (AOR= 3.65; 95% CI: 1.40, 9.50; P= 0.008), (AOR= 12.99; 95% CI: 6.34, 26.59; P= 0.001), and (AOR= 1.17; 95% CI: 1.02, 1.36; P= 0.026), respectively.The results revealed oral leukoplakia-like lesions to be significantly associated with shammah use. Therefore, it is important to develop comprehensive shammah prevention programs in Yemen.

TITLE: The benefit of adding a physiotherapy or occupational therapy intervention programme to a standardized group-based interdisciplinary rehabilitation programme for patients with chronic widespread pain: a randomized active-controlled non-blinded trial.ABSTRACT: To evaluate the benefit of adding occupational therapy or physiotherapy interventions to a standard rehabilitation programme targeted for chronic widespread pain.Randomized active-controlled non-blinded trial.Women with chronic widespread pain recruited in a tertiary outpatient clinic.Participants were randomized to a two-week, group-based standard rehabilitation programme followed by 16 weeks of group-based occupational therapy (Group B,  = 43) or 16 weeks of group-based physiotherapy (Group B,  = 42). Group A only received the two-week rehabilitation programme acting as comparator ( = 96).Primary outcomes were the Assessment of Motor and Process Skills and Short Form-36 (SF36) Mental Component Summary score.Mean changes in motor and process ability measures were clinically and statistically insignificant and without differences across the three groups assessed 88 weeks from baseline. Motor ability measures: -0.006 (95% confidence interval (CI): -0.244 to 0.233) in Group B; -0.045 (95% CI: -0.291 to 0.202) in Group B; and -0.017 (95% CI: -0.248 to 0.213) in Group A,  = 0.903. Process ability measures: 0.087 (95% CI: -0.056 to 0.231) in Group B; 0.075 (95% CI: -0.075 to 0.226) in Group B; and 0.072 (95% CI: -0.067 to 0.211) in Group A,  = 0.924. Mean changes in patient-reported outcomes were likewise small; clinically and statistically insignificant; and independent of group allocation, except for the SF36 mental component summary score in the B group: 8.58 (95% CI: 1.75 to 15.41).Participants were on average stable in observation-based measures of functional ability and patient-reported outcomes, except in overall mental well-being, favouring the enhanced intervention. Efficacy of additional interventions on functional ability remains uncertain.

TITLE: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy: Results of the Korean South West Oncology Group (KSWOG) Study.ABSTRACT: Data on the efficacy of olanzapine in patients receiving moderately emetogenic chemotherapy (MEC) are limited. This study aimed to evaluate and compare the efficacy of olanzapine versus placebo in controlling nausea and vomiting in patients receiving MEC.We conducted a randomized, double-blind, placebo-controlled study to determine whether olanzapine can reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve the quality of life (QOL) in patients receiving palonosetron and dexamethasone as prophylaxis for MEC-induced nausea and vomiting. The primary end point was complete response for the acute phase (0-24 hours after chemotherapy). The secondary end points were complete response for the delayed (24-120 hours) and overall phase (0-120 hours), proportion of significant nausea (visual analogue scale ≥ 25 mm), use ofrescue medications, and effect on QOL.Fifty-six patients were randomized to the olanzapine (n=29) and placebo (n=27) groups. Complete response rates were not significantly different between the olanzapine and placebo groups in the acute (96.5% vs. 88.0%, p=0.326), delayed (69.0% vs. 48.0%, p=0.118), and overall phases (69.0% vs. 48.0%, p=0.118). However, the percentage of patients with significant nausea (17.2% vs. 44.0%, p=0.032) and the use of rescue medications (0.03±0.19 vs. 1.88±2.88, p=0.002) were lower in the olanzapine group than in the placebo. Furthermore, the olanzapine group demonstrated better QOL (p=0.015).Olanzapine combined with palonosetron and dexamethasone significantly improved QOL and vomiting control among previously untreated patients receiving MEC, although the efficacy was limited to the reduction of the frequency of CINV.

TITLE: Dutasteride is associated with reduced risk of transrectal prostate biopsy-associated urinary tract infection and related hospitalizations.ABSTRACT: To evaluate whether the use of dutasteride is associated with a lower risk of transrectal prostate biopsy-associated urinary tract infection (TPBA-UTI) among men in the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study.Retrospective analysis of 6045 men undergoing 2-year repeat prostate biopsy in REDUCE. Participants were randomized to receive dutasteride 0.5 mg or placebo daily. TPBA-UTI was defined as the presence of urinary symptoms and the prescription of antibiotics by the treating physician within 30 days after biopsy. Severe TPBA-UTI was defined as TPBA-UTI requiring hospitalization. Comparison of TPBA-UTI between treatment arms was done using Chi-square test and logistic regression adjusting for participant characteristics.Of the subjects included in the study, 3067 (50.7%) were randomized to the placebo arm and 2978 (49.3%) to the dutasteride arm. A total 51 (0.8%) men had TPBA-UTI, including 38 (1.2%) in the placebo arm and 13 (0.4%) in the dutasteride arm (univariable relative risk [RR] = 0.35, P = 0.001; multivariable odds ratio [OR] = 0.34, P = 0.003). The number needed to treat (NNT) to prevent one TPBA-UTI was 125 subjects. Of these, 14 (28%) had severe TPBA-UTI, including 12 (0.4%) in the placebo arm and only 2 (0.07%) in the dutasteride arm (univariable RR = 0.17, P = 0.021; multivariable OR = 0.17, P = 0.031). The NNT to prevent one severe TPBA-UTI was 309 subjects.Among men undergoing a 2-year repeat prostate biopsy, the use of dutasteride for 2 years was associated with a reduced the risk of overall and severe TBPA-UTI. CLINICALTRIALS.NCT00056407.

TITLE: The effect of foot reflexology massage on delirium and sleep quality following cardiac surgery: A randomized clinical trial.ABSTRACT: Delirium is the most common neurologic disorder after cardiac surgery and affects both short and long-term outcomes. This study was conducted to evaluate the effect of foot reflexology massage on the incidence of delirium and sleep quality in patients undergoing cardiac surgery.In this randomized clinical trial, 60 patients who were candidates for CABG surgery were randomly assigned into two equal groups (n = 30); intervention and control groups. In the intervention group, foot reflexology massage was done on each foot for 15 min, for two consecutive days. Delirium observation screening scale, the Richard Campbell sleep questionnaire (RSCQ), and pain intensity using VAS were compared.in the second postoperative day, delirium was observed in 8 (26.7 %) and 7 (23.3 %) of patients in the intervention and control groups, respectively (p > 0.05). The measured odds ratio for the effect of massage on delirium is 0.83 (95 %CI 0.71-2.69, p = 0.76). The difference in RSCQ scores was not significant between groups of intervention and control (68.32 ± 10.41 VS. 62.80 ± 11.86, P = 0.06). The pain intensity was lower in the intervention group (P < 0.001).Foot reflexology was not effective in reducing delirium and improving the sleep quality, but the pain intensity was decreased. It seems that the precise pathology and predicting model of delirium should be identified, and appropriate interventions should be planned accordingly.

TITLE: Using a cane for one month does not improve walking or social participation in chronic stroke: An attention-controlled randomized trial.ABSTRACT: To examine the effects of the provision of a cane, delivered to ambulatory people with chronic stroke, for improving walking and social participation.Two-arm, randomized trial.Community-based.Ambulatory individuals with chronic stroke.The experimental intervention was the provision of a single-point cane during one month. The control group received a placebo intervention.Walking speed, step length, cadence, walking capacity, and walking confidence were measured without the cane to examine its rehabilitative effect. Walking speed was also measured with the cane for inclusiveness, and social participation was measured for examining carry over effects. Outcomes were measured at baseline, and after one and two months.Fifty individuals were included. In the experimental group, mean age was 69 years (SD 14), and walking speed was 0.58 m/s (SD 0.17). In the control group, mean age was 68 years (SD 13), and walking speed was 0.63 m/s (SD 0.15). When walking the cane, after one and after two months, there were no between-group differences in any measures. When walking the cane, after one month, the experimental group walked 0.14 m/s (95% CI 0.05-0.23) faster than the control group and after two months, they were still walking 0.18 m/s (95% CI 0.06-0.30) faster.Use of a cane improved walking speed, only when participants walked with the cane. Use of cane for one month did not improve walking outcomes, when walking without the cane. People with stroke would need to continue to use the cane to maintain any benefits in walking speed.

TITLE: Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized Controlled Trial.ABSTRACT: The primary objective in this study was to evaluate the effects of vaginal progesterone supplementation for the prolongation of the latency period in preterm labor. The secondary objectives were to evaluate gestational age at delivery, rates of preterm birth less than 34 and 37 weeks, obstetric outcomes, maternal compliance with medication use, and side effects.A randomized controlled, unblinded trial was performed. Ninety women with preterm labor occurring at 24 to 34 weeks were either randomized to a vaginal progesterone group (44 women) receiving tocolytic and antenatal corticosteroids treatment combined with vaginal micronized progesterone (400 mg everyday) or to the no-progesterone group (46 women) receiving tocolytic and antenatal corticosteroids treatment only.Latency periods were more prolonged in the vaginal progesterone group than in the no-progesterone group (32.8 ± 18.7 vs. 25.8 ± 22.7 days, p = 0.045). Gestational age at delivery in the vaginal progesterone group was also higher than in the no-progesterone group (37 vs. 35 weeks, p = 0.027). There were significant reduction rates of preterm birth less than 34 weeks (13.6% vs. 39.1%, p = 0.012), low birth weight (29.5% vs. 50%, p = 0.048), neonatal respiratory distress syndrome (13.6% vs. 37%, p = 0.021), and neonatal intensive care unit admission (6.8% vs. 28.3%, p = 0.017).Combined treatment with vaginal progesterone 400 mg could prolong the latency period in preterm labor when compared with no progesterone.

TITLE: Vancomycin-associated nephrotoxicity in adult medicine patients: incidence, outcomes, and risk factors.ABSTRACT: The prevalence of vancomycin-associated nephrotoxicity (VAN) is reported to vary from 1.0-42.6%, with most data from critically ill patients. Evaluation of VAN among internal medicine patients is lacking. Our objectives were to determine the incidence, time-course, outcomes, and risk factors of VAN in adult internal medicine patients.Retrospective cohort.Tertiary care academic medical center.A total of 125 adult internal medicine patients receiving vancomycin treatment with mean baseline creatinine clearance of 84.6 ± 27.6 ml/min.Vancomycin treatment for a minimum of 72 hours.Nephrotoxicity, defined as an increase in serum creatinine of 0.5 mg/dl or 50% above baseline (whichever was larger), occurred in 17 (13.6%) of 125 patients. No patients with VAN progressed to Loss or End stage as defined by the RIFLE criteria. The incidence rate of VAN was 0.02 cases/day of vancomycin treatment. Nephrotoxicity developed at a median of 4.5 days (interquartile range [IQR] 2.2-4.9) peaked at 5.7 days (IQR: 3.8-9.6), and resolved in 70.6% of the cases within 16.5 days (IQR: 6.0-17.8) after onset. On multivariable logistic regression analysis, after controlling for hypotensive episodes, Charlson Comorbidity Index, and baseline creatinine clearance, concomitant use of piperacillin-tazobactam was associated with increased VAN (adjusted odds ratio 5.36, 95% confidence interval 1.41-20.5).Vancomycin-associated nephrotoxicity is prevalent among internal medicine patients, with 5.36-fold higher odds if piperacillin-tazobactam is concomitantly administered.

TITLE: Ropivacaine Intramuscular Paracervical Injections for Pediatric Headache: A Randomized Placebo-Controlled Trial.ABSTRACT: We seek to determine whether ropivacaine cervical paraspinal injections compared with normal saline solution injections provide headache relief to pediatric patients that is sufficient for emergency department (ED) discharge.We enrolled children aged 7 to 17 years in a double-blinded, randomized, controlled trial of patients presenting to a pediatric ED with headache. Subjects were randomized into 1 of 3 groups: bilateral cervical paraspinal injections of either (1) 0.5% ropivacaine or (2) normal saline solution, or (3) a natural history group (not blinded) receiving no headache therapy for the first 30 minutes. Pain scores were assessed at enrollment and at 10-, 20-, and 30-minute intervals after the administration of the injections. After the intervention period of 30 minutes, additional therapy was provided as needed. Primary outcome was the proportion of children discharged with adequate pain relief at 30 minutes without additional therapy. Secondary outcomes included reduction in pain scores, reoccurrence of headache, and re-presentation to health care with headache.One hundred fifty-three children were enrolled. The proportion discharged with adequate pain relief 30 minutes after the injections did not differ between the 2 intervention groups (32% in the ropivacaine group versus 28% in the saline solution group; effect difference 4%; 95% confidence interval -14% to 21%). In contrast, only 4% percent of patients in the natural history group were discharged without additional therapy after the 30-minute assessment. Reduction of pain scores (2.0 and 2.2 in ropivacaine versus saline solution), headache reoccurrence, and return to care was similar between the 2 treatment groups.Cervical paraspinal injections of either ropivacaine or saline solution were effective for approximately one third of patients.

TITLE: Effect of magnesium supplementation on depression status in depressed patients with magnesium deficiency: A randomized, double-blind, placebo-controlled trial.ABSTRACT: The aim of this study was to determine the effect of magnesium supplementation on the depression status of depressed patients suffering from magnesium deficiency.Sixty depressed people suffering from hypomagnesemia participated in this trial. The individuals were randomly categorized into two groups of 30 members; one receiving two 250-mg tablets of magnesium oxide (MG) daily and the other receiving placebo (PG) for 8 wk. The Beck Depression Inventory-II was conducted and the concentration of serum magnesium was measured.At the end of intervention, 88.5% of the MG and 48.1% of the PG (P = 0.002) had a normal level of magnesium. The mean changes of serum magnesium were significantly different across the two groups. After the intervention, the mean Beck score significantly declined. However, in the MG, this reduction was more significant than in the PG (P = 0.02), so that the mean changes in this group experienced 15.65 ± 8.9 reduction, but in the PG, it declined by 10.40 ± 7.9.Daily consumption of 500 mg magnesium oxide tablets for ≥8 wk by depressed patients suffering from magnesium deficiency leads to improvements in depression status and magnesium levels. Therefore, assessment of the magnesium serum and resolving this deficiency positively influence the treatment of depressed patients.

TITLE: The sex of the foetus affects maternal blood glucose concentrations in overweight and obese pregnant women.ABSTRACT: There is increasing evidence that the sex of the foetus may alter the maternal metabolic milieu during pregnancy. Following a randomized controlled trial of exercise in overweight and obese pregnant women, we assessed whether the sex of the foetus was associated with changes in maternal metabolism. Data were analysed on 74 randomized participants who completed the trial, including 38 mothers carrying males and 36 mothers carrying females. At 19 weeks of gestation, mothers carrying boys had higher blood glucose concentrations than those carrying girls (5.4 vs 4.9 mmol/l; p = .046). At 36 weeks of gestation, differences were more marked, with blood glucose concentrations 15% higher in mothers carrying females (5.7 vs 5.0 mmol/l; p = .004). In addition, mothers carrying girls had higher concentrations of hs-CRP across pregnancy (5.0 vs 3.6 mg/l; p = .029). Our findings provide further evidence that the sex of the foetus appears to influence maternal metabolism.

TITLE: Letrozole and human menopausal gonadotropin for ovulation induction in clomiphene resistance polycystic ovary syndrome patients: A randomized controlled study.ABSTRACT: To compare the effects of letrozole and human menopausal gonadotropin (HMG) in the treatment of patients with polycystic ovary syndrome (PCOS) resistant to clomiphene citrate (CC).A total of 96 clomiphene resistance polycystic ovary syndrome patients infertility were randomly divided into an LE group, and HMG group (n = 48). LE group orally received letrozole at 5.0 mg/d on the 3rd-5th days of menstrual cycle for 5 consecutive days, and 75 U/d HMG was given through intramuscular injection for 5 days starting from the third day of menstrual cycle in HMG group. Number of growing and mature follicles, serum E2 (pg/mL), serum P (ng/mL), endometrial thickness, occurrence of pregnancy and miscarriage were observed.There was no significant difference in the number of ovulation cycles between the 2 groups (53.6% vs 64.7%, P > .05). The number of mature follicular cycles in the HMG group was higher than that of the letrozole group (P < .01). There were no significant differences in the clinical pregnancy rate (22.9% vs 27.1%, P > .05) and abortion rate (6.2% vs 10.4%, P > .05). There was no significant difference in the endometrial thickness between the 2 groups on the day of HCG injection [(9.1 ± 0.2) mm vs (10.7 ± 1.6) mm, P > .05]; the serum estradiol (E2) was lower in the letrozole group. The incidence of ovarian cysts was lower than that of HMG group (P < .05). There was2 ovarian hyperstimulation syndrome in the letrozole group; the incidence of ovarian hyperstimulation syndrome in the HMG group was 12.5%.Letrozole-induced ovulation can obtain ovulation rate and pregnancy rate similar to gonadotropin, but reduce the risk associated with treatment. It can be used as an effective ovulation option for patients with polycystic ovary syndrome who are resistant to clomiphene.

TITLE: Eplerenone might affect atrial fibrosis in patients with hypertension.ABSTRACT: Eplerenone is reported to reduce the development of atrial fibrillation (AF). The aim of this study was to clarify the mechanism of eplerenone for AF prevention from the viewpoint of P wave morphology, which is reported to correlate with atrial fibrosis.Thirty-five patients with hypertension, who were randomized to receive eplerenone (n = 16) or amlodipine (n = 19) for 1 year, were evaluated. P wave signal-averaged electrocardiography was recorded at baseline and 1 year after entry, and P wave duration (Ad) and P wave dispersion (P-disp) were obtained. Serum levels of intact procollagen type I N-terminal propeptide (PINP) and N-terminal procollagen-III peptide (PIIIP) were also measured.There were no significant differences in baseline clinical characteristics including Ad, P-disp, and the decrease in blood pressure at 1-year follow-up between the two groups. Ad and P-disp (mean ± standard deviation) significantly increased in patients on amlodipine after 1 year (140 ± 21 ms to 139 ± 19 ms vs 132 ± 10 ms to 136 ± 12 ms, P < 0.01 and 14 ± 7 ms to 9 ± 4 ms vs 12 ± 5 to 16 ± 8, P < 0.01, respectively). PINP was significantly more decreased in patients with eplerenone than amlodipine (56.6 ± 30.4 μg/mL to 46.6 ± 19.4 μg/mL vs 41.5 ± 16.2 μg/L to 48.7 ± 21.3 μg/L, P < 0.01). Percent changes of Ad, P-disp, PINP, and PIIIP were significantly smaller in patients with eplerenone than amlodipine (0.0 ± 4.7% vs 3.2 ± 4.4%, P < 0.05, - 28.6 ± 31.0% vs 46.3 ± 73.0%, P < 0.01, - 5.6 ± 38.1% vs 22.7 ± 42.7%, P < 0.05, and - 9.2 ± 25.1% vs 7.4 ± 19.0%, P < 0.05, respectively).Eplerenone reduced the increase of Ad and P-disp with a decrease of PINP and PIIIP, which might translate into reduction of atrial fibrosis. This study showed that eplerenone may be useful as upstream therapy for AF in patients with hypertension.

TITLE: "She Gave Me the Confidence to Open Up": Bridging Communication by Promotoras in a Childhood Obesity Intervention for Latino Families.ABSTRACT: Childhood obesity is a public health threat that disproportionally affects Latino youth in the United States. Active and Healthy Families (AHF) is a culturally tailored, family-based program for addressing obesity disparities in a predominantly immigrant Latino population. AHF was the first primary care, culturally tailored intervention for Latino children to significantly reduce BMI in a randomized controlled trial. The 10-week AHF intervention reduced BMI (kg/m) among overweight or obese children by 0.5, compared with an increase of 0.3 in the control group, yielding a -0.8 difference ( p < .01). A unique aspect of the program is its provider team: a physician, dietitian, and promotora. Because early feedback from families highlighted the importance of promotoras specifically, we sought to understand the unique mechanisms of promotora effectiveness in AHF. We conducted in-depth, semistructured interviews with the AHF providers ( n = 5) and parent participants ( n = 23) by phone between November 2012 and May 2013. In a grounded theory analysis, three main categories encompassing five themes emerged: (a) bridging communication by promotoras; (b) promotoras' personal qualities, including themes of kindness and caring and shared experiences with patients; and (c) impactful task performance, including themes of motivation, positive environment, and self-efficacy. Together, the themes serve as the basis of a conceptual model illustrating the process through which promotoras may enhance the impact of team-based obesity programs for the Latino community. Because this study identifies the specific ways through which promotoras can bridge cultural, linguistic, and other divides, it may inform development and dissemination of evidence-based approaches for obesity prevention in the Latino community.

TITLE: Cecal intubation time between cap-assisted water exchange and water exchange colonoscopy: a randomized-controlled trial.ABSTRACT: The water exchange (WE) method can decrease the discomfort of the patients undergoing colonoscopy. It also provides salvage cleansing and improves adenoma detection, but a longer intubation time is required. Cap-assisted colonoscopy leads to a significant reduction in cecal intubation time compared with traditional colonoscopy with air insufflation. The aim of this study was to investigate whether combined cap-assisted colonoscopy and water exchange (CWE) could decrease the cecal intubation time compared with WE.A total of 120 patients undergoing fully sedated colonoscopy at a regional hospital in southern Taiwan were randomized to colonoscopy with either CWE (n=59) or WE (n=61). The primary endpoint was cecal intubation time.The mean cecal intubation time was significantly shorter in CWE (12.0 min) compared with WE (14.8 min) (P=0.004). The volume of infused water during insertion was lower in CWE (840 ml) compared with WE (1044 ml) (P=0.003). The adenoma detection rate was 50.8 and 47.5% for CWE and WE, respectively (P=0.472). The Boston Bowel Preparation Scale scores were comparable in the two groups. Results from the multiple linear regression analysis indicated that WE with a cap, a higher degree of endoscopist's experience, a higher Boston Bowel Preparation Scale score, and a lower volume of water infused during insertion, without abdominal compression, without change of position, and without chronic laxative use, were significantly associated with a shorter cecal intubation time.In comparison with WE, CWE could shorten the cecal intubation time and required lower volume of water infusion during insertion without compromising the cleansing effect of WE.

TITLE: Methylprednisolone for prevention of ovarian hyperstimulation syndrome in patients with polycystic ovarian syndrome undergoing in-vitro fertilisation: a randomised controlled trial.ABSTRACT: This study aimed to evaluate the effect of methylprednisolone on prevention of ovarian hyperstimulation syndrome (OHSS) in polycystic ovarian syndrome (PCOS) patients undergoing in-vitro fertilisation (IVF). This randomised controlled trial was carried out between November 2009 and December 2013. A total of 219 eligible patients were randomly allocated for treatment (n = 108) or control groups (n = 111). The treatment group received oral methylprednisolone starting from the first day of stimulation. These patients also received an intravenous dose of methylprednisolone on the days of egg collection and embryo transfer. The control group received no glucocorticoid treatment to prevent OHSS. Nineteen percent of patients (18/93) who received methylprednisolone developed OHSS compared with 16.5% (15/91) in the control group and no significant difference was found (p = .61). There were no significant differences between treatment and control groups in the rates of implantation (10% versus 11%, p = .77) and clinical pregnancy (23.2% versus 17.7%, p = .46). Methylprednisolone did not reduce the incidence and severity of OHSS in PCOS patients undergoing IVF and no improvement in clinical outcomes was observed. Impact statement No significant differences were found in OHSS incidence and clinical outcomes between women who received methylprednisolone and control group. There seems to be no benefit for the routine use of glucocorticoids in IVF/ICSI treatments.

TITLE: Effect of Tranexamic Acid on Prevention of Hemorrhagic Mass Growth in Patients with Traumatic Brain Injury.ABSTRACT: Intracranial hemorrhage is a common complication of traumatic brain injury (TBI). The purpose of this study is evaluation of the effect of tranexamic acid (TXA) on hemorrhagic mass growth in TBI patients.In this randomized, double-blind clinical trial, 149 patients with TBI and any kind of blood on their computed tomography scan enrolled in the study and were randomly allocated to receive TXA or placebo. After 24 hours, computed tomography scan was repeated for assessing the changes in hemorrhage, new bleeding, and mass effects of blood on brain tissue. The primary outcome was growth of the hemorrhagic lesion. Data were analyzed by SPSS software using Fisher exact, chi-square, and Mann-Whitney U tests, as well as linear and logistic regression models.The incidence of hemorrhagic lesion growth was 20.5% in the TXA group and 22.7% in the placebo group. The difference was not significant (P = 0.87, RR = 0.89). The mean (standard deviation) of hemorrhagic lesion growth was 9.4 (15.3) in the TXA group and 10.2 (10.1) in the placebo group without significant difference (P = 0.27). The frequency of deaths (2.7% vs. 4%), adverse outcome at discharge (10.8% vs. 17.3%), and 3 months later (6.8% vs. 14.7%) in the TXA group were lower than the placebo, but the difference was not statistically significant. No side effect was observed with the administration of TXA.Administration of a short dose of TXA does not lead to significant prevention of growth of posttraumatic hemorrhagic lesion or improvement of clinical outcomes.

TITLE: A Randomized Trial of Incentives for Smoking Treatment in Medicaid Members.ABSTRACT: Low-income populations are especially likely to smoke and have difficulty quitting. This study evaluated a monetary incentive intended to increase smoking treatment engagement and abstinence among Medicaid recipients who smoke.Two-group randomized clinical trial of Incentive (n=948) and Control interventions (n=952) for smoking.Medicaid recipients recruited from primary care patients (n=920) and callers to the Wisconsin Tobacco Quit Line (n=980).Participants were offered five quitline cessation calls and were encouraged to obtain cessation medication (covered by Medicaid). All participants received payment for completing a baseline assessment and a 6-month smoking test. Only Incentive condition participants received compensation for taking counseling calls ($30 per call) and for biochemically verified abstinence at the 6-month visit ($40).Seven-day point-prevalence smoking abstinence 6-months post study entry and cost/quit.Incentive condition participants had significantly higher biochemically determined 7-day point-prevalence smoking abstinence rates 6 months after study induction than did Controls (21.6% vs 13.8%, respectively, p<0.0001). A positive treatment effect of incentives was present across other abstinence indices, but the size of effects and levels of abstinence varied considerably across indices. Incentive condition participants were also significantly more likely than non-incentivized Control participants to accept Wisconsin Tobacco Quit Line treatment calls and their acceptance of calls mediated their attainment of higher abstinence rates at 6-month follow-up. The cost/quit/participant averaged $4,268.26 for the Control participants and $3,601.37 for the Incentive participants.This study shows that fairly moderate levels of incentive payments for treatment engagement and abstinence (a total possible payment of $190) increased very low-income smokers' engagement and success in smoking cessation treatment.This study is registered at www.clinicaltrials.gov: NCT02713594.

TITLE: Impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy in patients with normal or mildly impaired renal functions.ABSTRACT: Discontinuation of metformin treatment in patients scheduled for elective coronary angiography (CAG) is controversial because of post-procedural risks including acute contrast-induced nephropathy (CIN) and lactic acidosis (LA). This study aims to discuss the safety of continuing metformin treatment in patients undergoing elective CAG with normal or mildly impaired renal functions.Our study was designed as a single-centered, randomized, and observational study including 268 patients undergoing elective CAG with an estimated glomerular filtration rate of >60 mL/min/1.73 m2. Of these patients, 134 continued metformin treatment during angiography, whereas 134 discontinued it 24 h before the procedure. CIN was defined as either a 25% relative increase in serum creatinine levels from the baseline or a 0.5 mg/dL increase in the absolute value that measured 48 h after CAG. Logistic regression analysis was performed to identify independent predictors of CIN and LA after CAG.Both groups were comparable in terms of demographics and laboratory values. CIN at 48 h was 8% (11/134) in the metformin continued group and 6% (8/134) in the metformin discontinued group (p=0.265). Patients in neither of the groups developed metformin-induced LA. Based on multiple regression analysis, the ejection fraction [p=0.029, OR: 0.760; 95% CI (0.590-0.970)] and contrast volume [p=0.016, OR: 0.022 95% CI (0.010-0.490)] were independent predictors of CIN.Patients scheduled for elective CAG with normal or mildly impaired renal functions and preserved left ventricular ejection fraction (>40%) may safely continue metformin treatment.

TITLE: Adenosine stress perfusion cardiac magnetic resonance imaging in patients undergoing intracoronary bone marrow cell transfer after ST-elevation myocardial infarction: the BOOST-2 perfusion substudy.ABSTRACT: In the placebo-controlled, double-blind BOne marrOw transfer to enhance ST-elevation infarct regeneration (BOOST) 2 trial, intracoronary autologous bone marrow cell (BMC) transfer did not improve recovery of left ventricular ejection fraction (LVEF) at 6 months in patients with ST-elevation myocardial infarction (STEMI) and moderately reduced LVEF. Regional myocardial perfusion as determined by adenosine stress perfusion cardiac magnetic resonance imaging (S-CMR) may be more sensitive than global LVEF in detecting BMC treatment effects. Here, we sought to evaluate (i) the changes of myocardial perfusion in the infarct area over time (ii) the effects of BMC therapy on infarct perfusion, and (iii) the relation of infarct perfusion to LVEF recovery at 6 months.In 51 patients from BOOST-2 (placebo, n = 10; BMC, n = 41), S-CMR was performed 5.1 ± 2.9 days after PCI (before placebo/BMC treatment) and after 6 months. Infarct perfusion improved from baseline to 6 months in the overall patient cohort as reflected by the semi-quantitative parameters, perfusion defect-infarct size ratio (change from 0.54 ± 0.20 to 0.43 ± 0.22; P = 0.006) and perfusion defect-upslope ratio (0.54 ± 0.23 to 0.68 ± 0.22; P < 0.001), irrespective of randomised treatment. Perfusion defect-upslope ratio at baseline correlated with LVEF recovery (r = 0.62; P < 0.001) after 6 months, with a threshold of 0.54 providing the best sensitivity (79%) and specificity (74%) (area under the curve, 0.79; 95% confidence interval, 0.67-0.92).Infarct perfusion improves from baseline to 6 months and predicts LVEF recovery in STEMI patients undergoing early PCI. Intracoronary BMC therapy did not enhance infarct perfusion in the BOOST-2 trial.

TITLE: Intravenous angiotensin II for the treatment of high-output shock (ATHOS trial): a pilot study.ABSTRACT: Patients with distributive shock who require high dose vasopressors have a high mortality. Angiotensin II (ATII) may prove useful in patients who remain hypotensive despite catecholamine and vasopressin therapy. The appropriate dose of parenteral angiotensin II for shock is unknown.In total, 20 patients with distributive shock and a cardiovascular Sequential Organ Failure Assessment score of 4 were randomized to either ATII infusion (N =10) or placebo (N =10) plus standard of care. ATII was started at a dose of 20 ng/kg/min, and titrated for a goal of maintaining a mean arterial pressure (MAP) of 65 mmHg. The infusion (either ATII or placebo) was continued for 6 hours then titrated off. The primary endpoint was the effect of ATII on the standing dose of norepinephrine required to maintain a MAP of 65 mmHg.ATII resulted in marked reduction in norepinephrine dosing in all patients. The mean hour 1 norepinephrine dose for the placebo cohort was 27.6 ± 29.3 mcg/min versus 7.4 ± 12.4 mcg/min for the ATII cohort (P =0.06). The most common adverse event attributable to ATII was hypertension, which occurred in 20% of patients receiving ATII. 30-day mortality for the ATII cohort and the placebo cohort was similar (50% versus 60%, P =1.00).Angiotensin II is an effective rescue vasopressor agent in patients with distributive shock requiring multiple vasopressors. The initial dose range of ATII that appears to be appropriate for patients with distributive shock is 2 to 10 ng/kg/min.Clinicaltrials.gov NCT01393782. Registered 12 July 2011.

TITLE: Effects of early treatment with zofenopril in patients with myocardial infarction and metabolic syndrome: the SMILE Study.ABSTRACT: To evaluate the clinical efficacy of the early administration of zofenopril in a group of patients with and without metabolic syndrome (MS+ and MS-) and anterior myocardial infarction enrolled in the Survival of Myocardial Infarction Long-Term Evaluation (SMILE) Study.Patients were randomized double-blind to zofenopril (n=719) or placebo (n=699) for 6 weeks. The primary end point was the effect of treatment on the 6-week combined occurrence of death and severe congestive heart failure. The secondary end point was the 1-year mortality rate.Of the 1418 patients included in this post-hoc analysis, 686 (48.3%) had MS. After 6 weeks of treatment zofenopril significantly reduced the incidence of all-cause death and severe congestive failure (risk reduction: 69%, 95% CI: 7-78; 2p=0.002) in MS+ patients. This was the case for 1-year mortality, too (29%, 95% CI: 4-41; 2p=0.048). Zofenopril was effective also in MS- patients but the amount of relative risk reduction was less than in MS+ for both the primary (-11%; 2p=0.61) and secondary endpoint (-19%; 2p=0.025).Results of this post-hoc analysis of the SMILE Study demonstrate the striking benefit of early administration of zofenopril in MS+ patients with acute anterior myocardial infarction.

TITLE: Do different culture intervals (2 × 24 hours) after thaw of cleavage stage embryos affect pregnancy rates? A randomized controlled trial.ABSTRACT: The aim of the study was to evaluate whether selecting embryos for transfer after prolonged culture after thaw (18-24 h) has better pregnancy rates than selecting embryos for transfer after short culture after thaw (2-5 h). We performed a double-blinded, randomized, controlled trial, evaluating 388 patients submitted to ART treatment who had embryos frozen on day-2 and subsequently transferred. All patients received the same endometrial priming with estradiol valerate followed by vaginal progesterone. Patients were randomized for Frozen embryo transfer 2-5 h after thaw (Group D2) or 18-24 h after thaw (Group D2/D3). The main Outcome Measure was ongoing pregnancy rate (OPR) at 20 weeks' gestation per embryo transfer. A total of 179 patients had embryos transferred 2-5 h after thaw and 209 patients had embryos transferred 18-24 h after thaw. The mean age in group D2 was 36 ± 4.4 and 36 ± 5.4 in group D2/D3. Ongoing pregnancy rate was 28% and 33.5% (p = 0.2) for groups D2 and D2/D3, respectively. These results suggest that increasing the culture time of embryos in one day to improve selection before transfer does not increase ongoing pregnancy rate. CLINICAL TRIAL REGISTRATION NUMBER: NCT03381001.

TITLE: Metformin for prevention of cesarean delivery and large-for-gestational-age newborns in non-diabetic obese pregnant women: a randomized clinical trial.ABSTRACT: To evaluate the use of metformin for preventing cesarean deliveries and large-for-gestational-age (LGA) newborn (NB) outcomes in non-diabetic obese pregnant women.This is a randomized clinical trial with obese pregnant women, divided into 2 groups: metformin group and control group, with followed-up prenatal routine. The gestational age of participants was less than or equal to 20 weeks and were monitored throughout entire prenatal period. For outcomes of delivery and LGA newborns, absolute risk reduction (ARR) and the number needed to treat (NNT) were calculated with a 95% confidence interval (CI).357 pregnant women were evaluated. From the metformin group (n = 171), 68 (39.8%) subjects underwent cesarean delivery, and 117 (62.9%) subjects from the control group (n = 186) had intercurrence (p < 0.01). As for the mothers' general characteristics, there was significance for marital status (p < 0.01). Maternal-fetal results presented reduced preeclampsia (p < 0,01). Primary prophylactic results presented an ARR of 23.1 times (95% CI: 13.0-33.4) with NNT of 4 (95% CI: 3.0-7.7) and no significant values for LGA NB (p > 0.01). Secondary prophylactic outcomes presented decreased odds ratio for preeclampsia (OR = 0.17, 95% CI: 0.10-0.41).The use of metformin reduced cesarean section rates, resulted in a small number of patients to be treated, but it did not reduce LGA NB. Administering a lower dosage of metformin from the early stages to the end of treatment may yield significant results with fewer side effects. Arch Endocrinol Metab. 2020;64(3):290-7.

TITLE: Effect of topical tranexamic acid in total hip arthroplasty patients who receive continuous aspirin for prevention of cardiovascular or cerebrovascular events: A prospective randomized study.ABSTRACT: Due to differences in pharmacological mechanism of action, the effect of tranexamic acid (TA) on aspirin-related bleeding remains unknown. We therefore conducted a prospective randomized study to elucidate: (1) the effect of topical TA administration on blood loss and transfusion rate in total hip arthroplasty (THA) patients receiving continuous aspirin for prevention of cardiovascular or cerebrovascular events; (2) 90-day complications of topical TA administration; (3) possible variables contributing to blood transfusion.Topical TA administration reduces blood loss and transfusion rate in THA patients receiving continuous aspirin.A total of 102 consecutive THA patients taking continuous aspirin were enrolled and randomized into two groups. In the topical TA (TTA) group (n=55), topical TA was administered at three points during THA; in the control group (n=47), the patients received saline solution as placebo. Based on drop in hemoglobin concentration, total estimated blood loss was calculated as the main assessment criterion. Secondary assessment criteria included transfusion rate and 90-day complications. Finally, a multivariate regression model was used to assess possible predictive factors for blood transfusion.(1) Significantly lower total blood loss was observed in the TTA group than in the control group (897±177ml vs. 1153±345ml, p<0.001). Furthermore, lower transfusion rate was observed in the TTA group than in the control group (10.9% vs. 34.0%, p=0.005). (2) No significant difference was observed between the two groups regarding 90-day complications. (3) We identified higher preoperative hemoglobin level (OR=0.675, p=0.002) and topical TA administration (OR=0.002, p=0.012) as negative predictive factors for blood transfusion.Topical application of TA was safe and beneficial in THA patients receiving continuous aspirin for prevention of cardiovascular or cerebrovascular events, to reduce blood loss and transfusion rate, without increasing the risk of 90-day complications.

TITLE: Rivaroxaban Versus Warfarin in Patients with Mechanical Heart Valves: Open-Label, Proof-of-Concept trial-The RIWA study.ABSTRACT: To date, vitamin K antagonists are the only available oral anticoagulants in patients with mechanical heart valves. In this way, we developed a pilot trial with rivaroxaban.The RIWA study was a proof-of-concept, open-label, randomized clinical trial and was designed to assess the incidence of thromboembolic and bleeding events of the rivaroxaban-based strategy (15 mg twice daily) in comparison to dose-adjusted warfarin. Patients were randomly assigned in a 1:1 ratio and were followed prospectively for 90 days.A total of 72 patients were enrolled in the present study. Of these, 44 patients were randomized: 23 patients were allocated to the rivaroxaban group and 21 to the warfarin group. After 90 days of follow-up, the primary outcome occurred in one patient (4.3%) in the rivaroxaban group and three patients (14.3%) in the warfarin group (risk ratio [RR] 0.27; 95% confidence interval [CI] 0.02-2.85; P = 0.25). Minor bleeding (without discontinuation of medical therapy) occurred in six patients (26.1%) in the rivaroxaban group versus six patients (28.6%) in the warfarin group (RR 0.88; 95% CI 0.23-3.32; P = 0.85). One patient in the warfarin group died from myocardial infarction. No cases of hemorrhagic stroke, valve thrombosis, peripheral embolic events, or new intracardiac thrombus were related in both groups.In this pilot study, rivaroxaban 15 mg twice daily had thromboembolic and bleeding events similar to warfarin in patients with mechanical heart valves. These data confirm the authors' proof-of-concept and suggest that a larger trial with a similar design is not unreasonable. CLINICALTRIAL.NCT03566303.

TITLE: Clinical value of tranexamic acid in unilateral and simultaneous bilateral TKAs under a contemporary blood-saving protocol: a randomized controlled trial.ABSTRACT: Despite the documented blood-saving effects of tranexamic acid (TNA) in total knee arthroplasty (TKA), the question whether clinical values of TNA are identical in unilateral and bilateral TKAs remains unclear. This study was undertaken to determine the clinical values of TNA in unilateral and simultaneous bilateral TKAs under a contemporary blood-saving protocol in terms of efficacy (total blood loss and transfusion rate) and safety (the incidences of symptomatic deep vein thrombosis and pulmonary embolism).One hundred and eighty unilateral and 146 bilateral TKA patients were randomized into TNA group or control group. In unilateral TKA patients, TNA (10 mg/kg) was administered intravenously 20 min before tourniquet deflation and repeated 3 h after surgery. In bilateral TKA patients, one more dose (10 mg/kg) was given before tourniquet deflation in the second TKA. A contemporary blood-saving protocol was applied to all patients. The TNA and control groups were compared separately in unilateral and bilateral TKA patients for the efficacy and safety variables.In unilateral TKA patients, the TNA group had less total blood loss (905 vs. 1,018 mL, p = 0.018) than the control group, but there was no difference in the allogenic transfusion rate (1 vs. 7 %, n.s.). In bilateral TKA patients, the TNA group showed no differences in total blood loss (1,282 vs. 1,379 mL, n.s.), but a significant reduction in the allogenic transfusion rate (7 vs. 27 %, p = 0.002). No symptomatic deep vein thrombosis or pulmonary embolism was found in all patients.This study demonstrates that the use of TNA reduces total blood loss, but the effects on the transfusion rate can differ depending on the type of TKAs (unilateral vs. bilateral) and the blood-saving protocols.

TITLE: Economic evaluation of multisystemic therapy for young people at risk for continuing criminal activity in the UK.ABSTRACT: To evaluate whether multisystemic therapy (MST) is more cost-effective than statutory interventions that are currently available for young offenders in England.A cost-offset evaluation of MST based on data from a randomised controlled trial conducted in North London, England, comparing MST with usual services provided by two youth offending teams (YOT). Service costs were compared to cost savings in terms of rates of criminal re-offending.108 adolescents, aged 11-17 years, were randomly allocated to MST+YOT (n = 56) or YOT alone (n = 52). Reductions in offending were evident in both groups, but were higher in the MST+YOT group. At 18-month follow-up, the MST+YOT group cost less in terms of criminal activity (£9,425 versus £11,715, p = 0.456). The MST+YOT group were significantly cheaper in terms of YOT services than the YOT group (£3,402 versus £4,619, p = 0.006), but more expensive including the cost of MST, although not significantly so (£5,687 versus £4,619, p = 0.195). The net benefit per young person for the 18-month follow-up was estimated to be £1,222 (95% CI -£5,838 to £8,283).The results reported in this study support the finding that MST+YOT has scope for cost-savings when compared to YOT alone. However, the limitations of the study in terms of method of economic evaluation, outcome measures used and data quality support the need for further research.

TITLE: Dronabinol increases pain threshold in patients with functional chest pain: a pilot double-blind placebo-controlled trial.ABSTRACT: Noncardiac chest pain is associated with poor quality of life and high care expenditure. The majority of noncardiac chest pain is either gastresophageal reflux disease related or due to esophageal motility disorders, and the rest are considered functional chest pain (FCP) due to central and peripheral hypersensitivity. Current treatment of FCP improves 40-50% of patients. Cannabinoid receptors 1 (CB1) and 2 (CB2) modulate release of neurotransmitters; CB1 is located in the esophageal epithelium and reduces excitatory enteric transmission and potentially could reduce esophageal hypersensitivity. We performed a prospective study to evaluate its effects on pain threshold, frequency, and intensity in FCP. Subjects with FCP received dronabinol (5 mg, twice daily; n = 7; average age, 44 years; mean body mass index, 26.7) or placebo (n = 6; average age, 42 years; mean body mass index, 25.9) for 28 days (4 weeks). Chest pain, general health, and anxiety/depression questionnaires were assessed at baseline and at 4 weeks. Subjects underwent an esophageal balloon distention test prior to treatment and on last day of the study. Dronabinol increased pain thresholds significantly (3.0 vs. 1.0; P = 0.03) and reduced pain intensity and odynophagia compared to placebo (0.18 vs. 0.01 and 0.12 vs. 0.01, respectively, P = 0.04). Depression and anxiety scores did not differ between the groups at baseline or after treatment. No significant adverse effects were observed. In this novel study, dronabinol increased pain threshold and reduced frequency and intensity of pain in FCP. Further, large scale studies are needed to substantiate these findings.

TITLE: Effect of perioperative sodium bicarbonate administration on renal function following cardiac surgery for infective endocarditis: a randomized, placebo-controlled trial.ABSTRACT: Patients with infective endocarditis (IE) have an elevated risk of renal dysfunction because of extensive systemic inflammation and use of nephrotoxic antibiotics. In this randomized, placebo-controlled trial, we investigated whether perioperative sodium bicarbonate administration could attenuate postoperative renal dysfunction in patients with IE undergoing cardiac surgery.Seventy patients randomly received sodium chloride (n = 35) or sodium bicarbonate (n = 35). Sodium bicarbonate was administered as a 0.5 mmol/kg loading dose for 1 h commencing with anesthetic induction, followed by a 0.15 mmol/kg/h infusion for 23 h. The primary outcome was peak serum creatinine (SCr) level during the first 48 h postoperatively. The incidence of acute kidney injury, SCr level, estimated glomerular filtration rate, and major morbidity endpoints were assessed postoperatively.The peak SCr during the first 48 h postoperatively (bicarbonate vs.1.01 (0.74, 1.37) mg/dl vs. 0.88 (0.76, 1.27) mg/dl, P = 0.474) and the incidence of acute kidney injury (bicarbonate vs.29% vs. 23%, P = 0.584) were similar in both groups. The postoperative increase in SCr above baseline was greater in the bicarbonate group than in the control group on postoperative day 2 (0.21 (0.07, 0.33) mg/dl vs. 0.06 (0.00, 0.23) mg/dl, P = 0.028) and postoperative day 5 (0.23 (0.08, 0.36) mg/dl vs. 0.06 (0.00, 0.23) mg/dl, P = 0.017).Perioperative sodium bicarbonate administration had no favorable impact on postoperative renal function and outcomes in patients with IE undergoing cardiac surgery. Instead, it was associated with possibly harmful renal effects, illustrated by a greater increase in SCr postoperatively, compared to control.ClinicalTrials.gov, NCT01920126 . Registered on 31 July 2013.

TITLE: Outcome of Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty for Early Medial Compartment Arthritis: A Randomized Study.ABSTRACT: With increasing number of patients with early osteoarthritis of knee opting for total knee arthroplasty (TKA), there has been increase in patients dissatisfied with surgical outcomes. It is being presumed that offering unicondylar knee arthroplasty (UKA) to them would improve outcomes.Primary objective of our study was to look for any difference in patient-reported outcome and function at 2-year follow-up in patients undergoing UKA as compared to TKA. Our study was a randomized study with parallel assignment conducted at a high-volume specialized arthroplasty center. Eighty patients with bilateral isolated medial compartment knee arthritis were randomized into simultaneous 2-team bilateral TKA (n = 40) and UKA (n = 40) group. We finally analyzed 36 patients in each group. Main outcome measure was improvement in Knee Outcome Survey-Activities of Daily Living Scale (KOS-ADLS) and High Activity Arthroplasty Score (HAAS) obtained at 2-year follow-up.Improvement in KOS-ADLS and HAAS at 2 years was similar (P = .2143 and .2010) in both groups. Performance as assessed with Delaware index was also similar. Length of hospital stay was less in UKA group (6.6 days as against 5.4 days). Complications and readmission rates were more in TKA group (nil in UKA group; 08 in TKA group).At 2-year follow-up, UKA provides similar improvement in patient-reported outcomes, function, and performance as compared to TKA when performed in patients with early arthritis. However, UKA patients have shorter hospital stay and fewer complications.

TITLE: Preoperative butorphanol and flurbiprofen axetil therapy attenuates remifentanil-induced hyperalgesia after laparoscopic gynaecological surgery: a randomized double-blind controlled trial.ABSTRACT: Several studies indicate that remifentanil exposure may engender opioid-induced hyperalgesia. Butorphanol and flurbiprofen axetil are proposed as adjunctive analgesics for postoperative pain control. This randomized double-blind controlled study was designed to investigate the antihyperalgesic effects of butorphanol combined with flurbiprofen axetil on opioid-induced hyperalgesia.One hundred and twenty patients undergoing elective laparoscopic gynaecological surgery with sevoflurane anaesthesia were randomized to one of four groups, as follows: intraoperative sufentanil 0.30 µg kg (Group S); remifentanil 0.30 µg kg min (Group R); intraoperative remifentanil and pre-anaesthesia butorphanol 20 µg kg (Group B); or intraoperative remifentanil and pre-anaesthesia butorphanol 10 µg kg combined with flurbiprofen axetil 0.5 mg kg (Group BF). Sufentanil was used to control postoperative pain. The threshold and area of postoperative mechanical hyperalgesia were measured with Von Frey filaments. Pain intensity, sufentanil consumption, and side-effects were recorded for 24 h after surgery.Compared with Group S, remifentanil anaesthesia increased the pain score, postoperative sufentanil consumption, and area of hyperalgesia [mean 49.9 (sd 8.6) vs 60.5 (10.0) cm, P<0.001] and reduced the hyperalgesia threshold on the dominant inner forearm [mean 89.5 (sd 23.4) vs 60.6 (22.6) g, P=0.004]. Compared with Group R, the pain score, sufentanil consumption, and area of hyperalgesia were reduced and hyperalgesia threshold was elevated likewise in Groups B and BF. However, the efficacy in Group BF was higher than in Group B (P=0.021).The preoperative combination of butorphanol and flurbiprofen axetil effectively ameliorated opioid-induced hyperalgesia in patients undergoing laparoscopic gynaecological surgery under sevoflurane-remifentanil anaesthesia.NCT02043366.

TITLE: Efficacy of iron-supplement bars to reduce anemia in urban Indian women: a cluster-randomized controlled trial.ABSTRACT: India's high prevalence of iron-deficiency anemia has largely been attributed to the local diet consisting of nonheme iron, which has lower absorption than that of heme iron. We assessed the efficacy of the consumption of iron-supplement bars in raising hemoglobin concentrations and hematocrit percentages in anemic (hemoglobin concentration <12 g/dL) Indian women of reproductive age. The Let's be Well Red study was a 90-d, pair-matched, cluster-randomized controlled trial. A total of 361 nonpregnant women (age 18-35 y) were recruited from 10 sites within Mumbai and Navi Mumbai, India. All participants received anemia education and a complete blood count (CBC). Random assignment of anemic participants to intervention and control arms occurred within 5 matched site-pairs. Intervention participants received 1 iron-supplement bar (containing 14 mg Fe)/d for 90 d, whereas control subjects received nothing. CBC tests were given at days 15, 45, and 90. Primary outcomes were 90-d changes from baseline in hemoglobin concentrations and hematocrit percentages. Linear mixed models and generalized estimating equations were used to model continuous and binary outcomes, respectively. Of 179 anemic participants, 136 (76.0%) completed all follow-up assessments (65 intervention and 71 control participants). Baseline characteristics were comparable by arm. Mean hemoglobin and hematocrit increases after 90 d were greater for intervention than for control participants [1.4 g/dL (95% CI: 1.3, 1.6 g/dL) and 2.7% (95% CI: 2.2%, 3.2%), respectively]. The anemia prevalence at 90 d was lower for intervention (29.2%) than for control participants (98.6%) (OR: 0.007; 95% CI: 0.001, 0.04). The daily consumption of an iron-supplement bar leads to increased hemoglobin concentrations and hematocrit percentages and to a lower anemia prevalence in the target population with no reported side effects. This intervention is an attractive option to combat anemia in India. This trial was registered at clinicaltrials.gov as NCT02032615.

TITLE: Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial.ABSTRACT: In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST) on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED) visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients.This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110) were randomized to pharmacogenetic profiling (n = 57). The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53) received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR), 0.65; 95% confidence interval (CI), 0.32-1.28; P = 0.21) and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27-0.82; P = 0.007). The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31-1.21; P = 0.16) and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34-0.99; P = 0.045). Differences in composite outcomes at 60 days (exploratory endpoints) were also found. Of the total 124 drug therapy recommendations passed on to clinicians, 96 (77%) were followed. These findings should be verified with additional prospective confirmatory studies involving real-world applications in larger populations to broaden acceptance in routine clinical practice.Pharmacogenetic testing of polypharmacy patients aged 50 and older, supported by an appropriate CDST, considerably reduced re-hospitalizations and ED visits at 60 days following enrollment resulting in potential health resource utilization savings and improved healthcare.ClinicalTrials.gov NCT02378220.

TITLE: Topical Ketoprofen Versus Placebo in Children Presenting With Ankle Sprain to the Emergency Department: A Randomized Controlled Study.ABSTRACT: Despite the favorable data concerning topical agents use in outpatient clinics, they are not commonly in emergency departments (EDs). The present study aimed to compare the effect of 2.5% topical ketoprofen (gel form) to placebo in children presenting with ankle sprain to the ED.Children between 7 and 18 years old presenting with ankle sprain composed the study population. Study patients were randomized into 2 study arms: 2.5% ketoprofen gel and placebo administered in a 5-cm area locally. Pain improvements at 15 and 30 minutes were measured by visual analog scale.Median pain reductions at 15 minutes for ketoprofen and placebo groups were 27.5 (16-39) and 5 (4-10), respectively. Median changes in pain intensity at 30 minutes for ketoprofen and placebo gel groups were 48 (43-52) and 9 (6-16), respectively. When compared 2 arms for the pain improvement at 15 and 30 minutes, the differences between 2 study drugs were 20 (13-28) and 35 (29-41), respectively. There were 7 (12.7%) rescue drug needs in the placebo group and 1 (1.7%) in the ketoprofen group (difference, 10.9%; 95% confidence interval, -6% to 7%; P = 0.83). There were no adverse effects in either group.Ketoprofen gel is superior to placebo in ceasing pain in children presenting with ankle sprain to the ED with a high safety profile.

TITLE: Electrocardiographic changes predict angiographic vasospasm after aneurysmal subarachnoid hemorrhage.ABSTRACT: Early identification of patients at risk of angiographic vasospasm after aneurysmal subarachnoid hemorrhage (SAH) may mitigate its sequelae. One mechanism that may contribute to angiographic vasospasm is increased central sympathetic activity, which is also thought to cause electrocardiographic (ECG) changes after SAH. Here, we perform the first study to determine the association between ECG changes and angiographic vasospasm after SAH.Exploratory analysis was performed on 413 patients from CONSCIOUS-1, a prospective randomized trial of clazosentan for the prevention of angiographic vasospasm. ECGs were obtained within 24 hours of aneurysm rupture and during the vasospasm risk period. Angiographic vasospasm was assessed using catheter angiography at baseline and 7 to 11 days after SAH. Multivariate logistic regression was used to identify significant associations.The most prevalent finding on ECG both immediately following SAH and during the vasospasm risk period was QT prolongation (42% and 25%, respectively). A prolonged QT interval and tachycardia on the baseline ECG were associated with angiographic vasospasm (OR, 1.86; 95% CI, 1.00-3.45; and OR, 10.83; 95% CI, 1.17-100.50, respectively). QT prolongation on ECG during the vasospasm risk period was also associated with angiographic vasospasm (OR, 3.53; 95% CI, 1.67-7.39). No ECG findings were associated with delayed ischemic neurological deficit, but tachycardia and ST changes were associated with worse clinical outcome.QT prolongation and tachycardia on ECG were independently associated with angiographic vasospasm after aneurysmal SAH on multivariate analysis.URL: http://clinicaltrials.gov. Unique Identifier: NCT00111085.

TITLE: Effect of dietary mannan-oligosaccharides on in vivo performance, nutrient digestibility and caecal content characteristics of growing rabbits.ABSTRACT: To evaluate the effect of mannan-oligosaccharides (MOS) on in vivo performance, nutrient digestibility, fermentation characteristics and caecal microbial populations of rabbits, 144 thirty-five days old hybrid Hyla were equally divided into three groups, one of which was fed the same diet without additives (control group), one with antibiotics (colistin sulphate, 144 mg/kg; tylosin, 100 mg/kg; oxytetracyclin, 1000 mg/kg) and one with MOS (1 g/kg of diet). Mortality rate, live weight, feed intake and feed conversion ratio were recorded up to 62 days of age. At 60 days nutrient digestibility was measured by acid insoluble ash method. The caecal content of 10 rabbits per group was collected at 62 days and analysed for volatile fatty acids production, ammonia content and microbial count. Rabbits from the control group had a significantly (p < 0.01) lower body weight at 62 days (1638.9 g vs. 1779.4 g and 1862.5 g, respectively for the control, MOS and antibiotic groups) while the antibiotic group showed a higher (p < 0.05) feed intake than the control group (127.9 g/day vs. 109.3 g/day). Rabbits from the MOS group had a higher apparent digestibility of cellulose (34.27% vs. 29.61% and 27.49%, respectively for the MOS, control and antibiotic groups) and, as a consequence a higher level of acetate in the caecal content (39.93 mmol/l vs. 34.21 mmol/l and 23.09 mmol/l, respectively for the MOS, control and antibiotic groups). Caecal microflora of the MOS group rabbits also had a higher fermentative activity in respect of protein source, as demonstrated by the higher productions of branched chain fatty acids. MOS and antibiotics significantly reduced the colonies of Coliformis (2.32 vs. 3.20 vs. 2.40 logCFU/g, respectively for the MOS, control and antibiotic groups, p < 0.01). Mannan-oligosaccharides at 1 g/kg of diet can be used as an alternative to antibiotics during the rabbit's growth period.

TITLE: Using Etomidate and Midazolam for Screening Colonoscopies Results in More Stable Hemodynamic Responses in Patients of All Ages.ABSTRACT: Recent studies have demonstrated that etomidate is a safe sedative drug with noninferior sedative effects. In our recent study, we revealed that etomidate/midazolam was more hemodynamically stable than propofol/midazolam in elderly patients undergoing colonoscopies. We aimed to investigate whether compared with propofol/midazolam, etomidate/midazolam causes fewer cardiopulmonary adverse events with noninferior efficacy for screening colonoscopies in patients of all ages.In this single-center, randomized, double-blind study, we prospectively enrolled 200 patients. The patients were divided into etomidate and propofol groups. The primary outcome was the occurrence of cardiopulmonary adverse events. The secondary outcomes were the proportion of patients with fluctuations in vital signs (oxygen desaturation and transient hypotension), adverse events interrupting the procedure, and sedation-related outcomes.Adverse cardiopulmonary events were more common in the propofol group than the etomidate group (65.0% vs 51.0%, respectively; p=0.045). Forty-six patients (46.0%) in the propofol group and 29 (29.0%) in the etomidate group experienced fluctuations in their vital signs (p=0.013). The proportions of patients experiencing adverse events that interrupted the procedure, including myoclonus, were not significantly different between the two groups (etomidate: 20.0% vs propofol: 11.0%; p=0.079). Both groups had similar sedation-related outcomes. Multivariate analysis revealed that compared with the propofol groups, the etomidate group had a significantly lower risk of fluctuations in vital signs (odds ratio, 0.427; 95% confidence interval, 0.230 to 0.792; p=0.007).Compared with using propofol/midazolam, using etomidate/midazolam for screening colonoscopies results in more stable hemodynamic responses in patients of all ages; therefore, we recommend using etomidate/midazolam for colonoscopies in patients with cardiovascular risk factors.

TITLE: The Influence of Adding Diphenhydramine Before Initiation of Moderate Sedation with Midazolam and Pethidine for Improving Quality of Colonoscopy.ABSTRACT: Combination of Intravenous benzodiazepines with opiates appears to be essential in order to guarantee high quality of moderate sedation during colonoscopy. Diphenhydramine is recommended for endoscopic procedures in difficult-to-sedate patients However, the studies supporting its use have yielded conflicting results.To assess the value of adding diphenhydramine hydrochloride before initiation of moderate sedation with midazolam and pethidine for Improving Quality of Sedation during colonoscopy.We conducted a prospective, randomized, double-blind, placebo-controlled study of 150 Patients undergoing diagnostic colonoscopy. Of 150 patients, data were analyzed for 100 patients randomized into two groups: Diphenhydramine group (n = 53) received 50 mg of diphenhydramine intravenously before initiation of moderate sedation with pethidine and midazolam while in placebo group (n = 47) received placebo in addition to pethidine and midazolam. Amount of pethidine and midazolam used and Quality of sedation were assessed.The mean doses of pethidine was significantly higher in placebo group as compared to diphenhydramine group (69.9 ± 35.4 mg vs 61.2 ± 21.0 mg, p < 0.01) However, no significant difference between the two groups regarding midazolam mean dose (4.9.±2.1 mg vs 4.8 ± 2.0 mg,p = 0.786). More patients in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (88.67% vs 59.57%,p < 0.001).Furthermore more endoscopist in diphenhydramine group were being very satisfied with the procedure as compared to those in placebo group (77.35% vs 51.06%,p < 0.001).Intravenous diphenhydramine hydrochloride given before initiation of midazolam and pethidine offers a significant Improvement of Quality of moderate Sedation during colonoscopy without increasing the number of sedation related complications.

TITLE: Influence of High Polyphenol Beverage on Stress-Induced Platelet Activation.ABSTRACT: Platelets are playing a crucial role in acute cardiovascular events. We investigated if physical stress activates platelets and whether this activation can be inhibited by a polyphenol-enriched diet.Blood samples were taken from a total of 103 athletes three weeks before, one day before, immediately as well as 24 hours and 72 hours after a marathon run. Participants were randomized, double-blinded and divided into two groups. One group received a polyphenol-rich beverage the other the same beverage without polyphenols. Besides analysis of platelet counts and impedance-aggregometric-measurement of platelet activity, soluble P-selectin and Endothelin-A measurements were performed.In the control group, runners showed a 2.2-fold increased platelet aggregation directly after completing a marathon and within the following three days when compared with baseline values (p<0.01). In accordance, significant increases in sP-selectin (57.52ng/ml vs. 94.86ng/ml;p<0.01) were detectable. In contrast, for the group consuming a beverage with increased polyphenol content (upper quartile of study beverage intake) we did not find any increase of platelet aggregation.Physical stress causes a significant increase in platelet activity. Our results demonstrate that a diet enriched in polyphenols is capable of preventing platelet activation. These findings might indicate a diminished cardiovascular stress-reaction following pre-exposition to polyphenol-enriched diet.

TITLE: Is structural hydroxyapatite tricalcium-phosphate graft or tricortical iliac crest autograft better for calcaneal lengthening osteotomy in childhood? interim results from a randomised, controlled non-inferiority study.ABSTRACT: To compare the structural durability of hydroxyapatite-tricalcium phosphate (HATCP) to autologous iliac crest bone graft in calcaneal lengthening osteotomy (CLO) for pes planovalgus in childhood.We present the interim results of ten patients (HATCP, n = 6 and autograft, n = 5) with a mean age of 11.5 years (8.2 to 14.2) from a randomised controlled non-inferiority trial with six months follow-up. The primary outcome was the stability of the osteotomy as measured by radiostereometric analysis. A non-inferiority margin of ≤ 2 mm osteotomy compression was set.At six months the data showed that the osteotomy had been compressed by a mean 1.97 mm (99.8% confidence interval -1.65 to 5.60) more in the HATCP group than in the autograft group. Migration of the CLO grafted with HATCP stabilised at six months rather than at six weeks with autograft.This is the first randomised trial to compare the efficacy of HATCP graft with autograft in terms of stability of CLO in children. Because of problems with the HATCP the trial was stopped. We do not recommend HATCP graft in its current structure for use in unfixed CLOs. Cite this article: Bone Joint J 2016;98-B:1554-62.

TITLE: Self-perceived postural balance correlates with postural balance and anxiety during the first year after stroke: a part of the randomized controlled GOTVED study.ABSTRACT: Postural balance is an important rehabilitation outcome, and screening stroke patients for confidence in postural balance during rehabilitation and before hospital discharge is recommended. Early supported discharge could improve postural balance self-confidence. This study aimed to investigate associations between patient self-confidence in postural balance and observer-assessed postural balance and anxiety during the first year after stroke. Whether very early supported discharge (VESD) affects self-confidence in postural balance compared with standard discharge was also evaluated.A longitudinal trial for with data extracted from a randomized controlled study of 140 adults with confirmed stroke was conducted. The experimental group received VESD. The control group was discharged according to the standard routine. Postural balance was assessed with Berg Balance Scale (BBS), Timed Up and Go (TUG) test, and Falls Efficacy Scale. Anxiety was assessed with the Hospital Anxiety and Depression Scale. Spearman's rank correlation coefficient (rho) was used to test associations between independent variables. The Wilcoxon signed-rank test was used to examine differences over time. A single test, according to Eid, Gollwitzer, and Schmidt, was used to test temporal differences in correlation.The correlation between self-confidence in postural balance and observer-assessed postural balance was 0.62-0.78 in the first year after stroke. The correlation between self-confidence and anxiety was 0.22-0.41 in the first year after stroke. Correlations did not differ by group affiliation at any time point when the postural balance was assessed with BBS. The intervention group had a significantly higher correlation (r = - 0.709) than the control group (r = - 0.416) when postural balance was assessed with the TUG test 1 month after discharge. There were no significant differences in correlations between confidence in postural balance and anxiety between the two groups at any time point.Patients with mild stroke can accurately assess their confidence in performing daily activities without falling. VESD does not substantially affect the correlation between self-confidence in postural balance and observer assessed postural balance and is safe to use as an alternative to standard discharge. Assessment of self-confidence can provide important information for rehabilitation planning and supporting the physical activity of patients after discharge.Clinical Trials.gov: NCT01622205 . Registered 19 June 2012 (retrospectively registered).

TITLE: Postoperative analgesic efficacy of ear acupuncture in patients undergoing abdominal hysterectomy: a randomized controlled trial.ABSTRACT: Numerous studies have revealed that acupuncture can increase the somatic pain threshold. Electro-acupuncture (EA) can help pain-relieving with minimal physiologic disturbance. Various painful disorders, as well as pain following various surgeries, like cesarean section, gastrostomy, and enterectomy were managed properly with acupuncture. Therefore we studied the postoperative analgesic effect of EA in patients undergoing abdominal hysterectomy.A randomized, prospective clinical trial study was carried out on 56 women undergoing hysterectomy under spinal anesthesia. Patients were allocated randomly to receive either spinal anesthesia and electric ear acupuncture (EEA group) or spinal anesthesia alone (control group). EEA was done by fine needles to anatomically defined 4 points of the ear: Shen Men Point, thalamus Point 26, Analgesia Point 3, and Uterus Point 58, and connected to EA therapeutic apparatus. After finishing surgery, the fine needles were substituted by permanent press needles to be removed after 24 hours. The primary outcome was the postoperative 24 h morphine consumption by patient-controlled analgesia, while secondary outcomes included Post-operative pain scores and postoperative 1st request of analgesia.Total morphine consumption in the first 24 postoperative hours was obviously reduced in the EEA group versus the control group (mean ± SD:6.214± 2.1319 mg vs 15.714 ± 3.3428 mg, d = - 3.3886, 95% Confidence interval = - 4.2061,-2.5712, p-value =0.000). The postoperative pain scores were significantly reduced in the EEA group in comparison to the control group, with delayed 1st request of postoperative analgesia.Electric ear acupuncture provides postoperative analgesia, reducing morphine requirement and consequently its side effects.The trial was registered before enrolment of the first patient at the Pan African Clinical Trial Registry ( www.pactr.org ) database ( PACTR201903770607799 , Date of registration: 5th March 2019).

TITLE: Impaired beta cell sensitivity to incretins in type 2 diabetes is insufficiently compensated by higher incretin response.ABSTRACT: The incretin effect is impaired in type 2 diabetes (T2D), but the underlying mechanisms are only partially understood. We investigated the relationships between the time course of the incretin effect and that of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) during oral glucose tolerance tests (OGTTs), thereby estimating incretin sensitivity of the beta cell, and its associated factors.Eight patients with T2D and eight matched subjects with normal glucose tolerance (NGT) received 25, 75, and 125 g OGTTs and corresponding isoglycemic glucose infusions (IIGI). The time course of the incretin effect, representing potentiation of insulin secretion by incretins (P), was determined by mathematical modelling as the time-dependent fold increase in insulin secretion during OGTT compared to IIGI. The time course of P was correlated with that of both GIP and GLP-1 in each subject (median r = 0.67 in NGT and 0.45 in T2D). We calculated an individual beta cell sensitivity to incretins (S) using a weighted average of GIP and GLP-1 (pooled incretin concentration, PIC), as the slope of the relationship between P and PIC. S was reduced in T2D (p < 0.01). In the whole group, mean PIC, GIP and GLP-1 concentrations during the OGTT were inversely correlated with S, but T2D had lower PIC, GIP and GLP-1 levels at the same S (p < 0.05).Relative incretin insensitivity is partly compensated for by higher incretin secretory responses. However, T2D shows both impairment in incretin sensitivity and abnormal compensation by incretin secretion.

TITLE: Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong.ABSTRACT: Most positive psychology interventions conducted in the West have been focused on the individual. Family relationships are highly valued in the Chinese collectivist culture, and it is of interest to know whether family-focused interventions can improve the well-being of Chinese people. We have previously reported the effectiveness of a positive psychology family intervention in terms of family well-being. Based on the data derived from the Happy Family Kitchen II project, this paper examines the effectiveness of a community-based positive psychology family intervention on subjective happiness and health-related quality of life.Thirty-one social service units and schools organized intervention programs for 2070 participants in Hong Kong. In a cluster randomized controlled trial, participants were randomly assigned on the basis of computer-generated numbers into the intervention group or the control group. The intervention programs emphasized one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. The control group engaged in activities unrelated to the intervention, such as arts and crafts workshops. Subjective happiness and mental and physical quality of life were assessed at baseline and at 4 weeks and 12 weeks postintervention.Data of 1261 participants were analyzed. The results showed that the intervention was more effective than the control condition in improving subjective happiness, with a small effect size, at 12 weeks postintervention (β = .15, p = .020, Cohen's d = .16). However, there were no improvements in mental and physical quality of life in the intervention group compared with the control group at 4 weeks (β = .39, p = .494, d = .05; β = -.10, p = 1.000, d = -.01, respectively) and 12 weeks postintervention (β = .71, p = .233, d = .08; β = -.05, p = 1.000, d = -.01, respectively). Furthermore, the booster session was no more effective than the tea gathering session in improving subjective happiness (β = .00, p = .990, d = .00) or mental (β = 1.20, p = 1.000, d = -.04) and physical quality of life (β = .15, p = 1.000, d = -.01).The analyses extend previous findings of salutary effects on family well-being by showing that positive psychology family interventions can improve subjective happiness. Suggestions for future research are proposed.ClinicalTrials.gov NCT01796275 . Retrospectively registered 19 February 2013.