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Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Effect of adjunctive vaginal progesterone after McDonald cerclage on the rate of second-trimester abortion in singleton pregnancy: a randomized controlled trial.Objective:To evaluate the effect of adjunctive use of vaginal progesterone after McDonald cerclage on the rate of second-trimester abortion in singleton pregnancy.Methods:A randomized controlled trial at Woman's Health Hospital, Assiut University, Egypt, between April 2017 and March 2019 enrolled women eligible for McDonald cerclage. After cerclage, participants were randomly assigned to receive progesterone (400 mg pessary) once daily until 37 weeks or no progesterone. The primary outcome was rate of abortion before 28 weeks. Secondary outcomes included gestational age at delivery, preterm delivery, mean birthweight, Apgar score, and admission to the neonatal intensive care unit (NICU).Results:The rate of spontaneous abortion was higher in the no-progesterone group (P=0.016). Mean gestational age and mean birthweight was higher in the progesterone group (P<0.001 and P=0.002, respectively). The frequency of preterm neonates, neonates with Apgar score less than 7, and admission to NICU was higher in the progesterone group than in the no-progesterone group (P=0.005, P=0.008, and P=0.044, respectively).Conclusion:Adjunctive use of vaginal progesterone after McDonald cerclage was found to decrease the frequency of second-trimester abortion and to improve perinatal outcomes in singleton pregnancy. Clinicaltrials.gov: NCT02846909.

Primary Outcome Measures is The frequency of spontaneous abortion before 28 weeks; Extracted Interventionsis is Progesterone; Conditions is Abortion ;Sex is FEMALE ;Age is ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.A randomized trial comparing the effects of sternal band and plate fixation of the sternum with that of figure-of-8 wires on sternal edge motion and quality of recovery after cardiac surgery.Objectives:We sought to compare the effects of conventional wire cerclage with that of the band and plate fixation of the sternum.Methods:A parallel randomized open-label trial with 1:1 allocation ratio compared healing after adult cardiac surgery using 'figure-of-8' stainless steel wire cerclage or a band and plate system (plates). The primary end point was maximal sternal edge displacement during active coughing of ≥2 mm in ≥2 of 4 sites measured with ultrasound by 2 assessors blinded to the other at 6 weeks postoperatively. Secondary end points at 12 weeks included ultrasound assessment, computed tomography (CT) scan and multidimensional assessment of quality of recovery using the Postoperative Quality of Recovery Scale.Results:Of 50 patients, 26 received plates and 24 wires. Two patients died and 1 withdrew consent leaving 25 plates and 22 wires for primary end point analysis. Operations included 37 coronary, 5 valve and 8 combined coronary and valve procedures. At 6 weeks, less sternal movement was observed in patients with plates than those with wires, 4% (1/25) vs 32% (7/22), P = 0.018. Agreement between observers was high, kappa = 0.850. At 12 weeks, less ultrasound motion was seen in patients with plates, 0% (0/23) than those with wires, 25% (5/20), P = 0.014. Recovery from pain was higher for patients with plates 92% (22/24) than those with wires 67% (14/21), P = 0.004. CT bone edge separation was less for plates 38% (9/24) than wires 71% (15/21), P = 0.036. CT mild bone synthesis or greater was similar between patients with plates 21% (5/24) and wires 14% (3/21), P = 0.71.Conclusions:Patients receiving the band and plate system had significantly less sternal edge motion than those receiving wires, 6 and 12 weeks after cardiac surgery and experienced less pain.Clinical trial registration:clinicaltrials.gov NCT03282578.

Primary Outcome Measures is Sternal motion; Extracted Interventionsis is Sternalock 360 sternal plating system Sternal Wires; Conditions is Cardiac Surgery|Sternal Closure ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Quality of Surgery and Outcome in Localized Gastrointestinal Stromal Tumors Treated Within an International Intergroup Randomized Clinical Trial of Adjuvant Imatinib.Importance:The association between quality of surgery and overall survival in patients affected by localized gastrointestinal stromal tumors (GIST) is not completely understood.Objective:To assess the risk of death with and without imatinib according to microscopic margins status (R0/R1) using data from a randomized study on adjuvant imatinib.Design, setting, and participants:This is a post hoc observational study on patients included in the randomized, open-label, phase III trial, performed between December 2004 and October 2008. Median follow-up was 9.1 years (IQR, 8-10 years). The study was performed at 112 hospitals in 12 countries. Inclusion criteria were diagnosis of primary GIST, with intermediate or high risk of relapse; no evidence of residual disease after surgery; older than 18 years; and no prior malignancies or concurrent severe/uncontrolled medical conditions. Data were analyzed between July 17, 2017, and March 1, 2020.Interventions:Patients were randomized after surgery to either receive imatinib (400 mg/d) for 2 years or no adjuvant treatment. Randomization was stratified by center, risk category (high vs intermediate), tumor site (gastric vs other), and quality of surgery (R0 vs R1). Tumor rupture was included in the R1 category but also analyzed separately.Main outcomes and measures:Primary end point of this substudy was overall survival (OS), estimated using Kaplan-Meier method and compared between R0/R1 using Cox models adjusted for treatment and stratification factors.Results:A total of 908 patients were included; 51.4% were men (465) and 48.6% were women (440), and the median age was 59 years (range, 18-89 years). One hundred sixty-two (17.8%) had an R1 resection, and 97 of 162 (59.9%) had tumor rupture. There was a significant difference in OS for patients undergoing an R1 vs R0 resection, overall (hazard ratio [HR], 2.05; 95% CI, 1.45-2.89) and by treatment arm (HR, 2.65; 95% CI, 1.37-3.75 with adjuvant imatinib and HR, 1.86; 95% CI, 1.16-2.99 without adjuvant imatinib). When tumor rupture was excluded, this difference in OS between R1 and R0 resections disappeared (HR, 1.05; 95% CI, 0.54-2.01).Conclusions and relevance:The difference in OS by quality of surgery with or without imatinib was associated with the presence of tumor rupture. When the latter was excluded, the presence of R1 margins was not associated with worse OS.Trial registration:ClinicalTrials.gov Identifier: NCT00103168.

Primary Outcome Measures is Overall survival; Extracted Interventionsis is imatinib mesylate; Conditions is Gastrointestinal Stromal Tumor ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Effect of In-Hospital Remote Ischemic Perconditioning on Brain Infarction Growth and Clinical Outcomes in Patients With Acute Ischemic Stroke: The RESCUE BRAIN Randomized Clinical Trial.Importance:Treatment with remote ischemic perconditioning has been reported to reduce brain infarction volume in animal models of stroke. Whether this neuroprotective effect was observed in patients with acute ischemic stroke remains unknown.Objective:To determine whether treatment with remote ischemic perconditioning administered to the leg of patients with acute ischemic stroke can reduce brain infarction volume growth.Design, setting, and participants:This proof-of-concept multicenter prospective randomized open-label with blinded end point clinical trial was performed from January 12, 2015, to May 2, 2018. Patients were recruited from 11 stroke centers in France. Of the 188 patients who received magnetic resonance imaging within 6 hours of symptom onset and were confirmed to have carotid ischemic stroke, 93 were randomized to receive treatment with lower-limb remote ischemic perconditioning in addition to standard care (the intervention group), and 95 were randomized to receive standard care alone (the control group).Interventions:Randomization on a 1:1 ratio to receive treatment with remote ischemic perconditioning (4 cycles of 5-minute inflations and 5-minute deflations to the thigh to 110 mm Hg above systolic blood pressure) in addition to standard care or standard care alone.Main outcomes and measures:The change in brain infarction volume growth between baseline and 24 hours, measured by a diffusion-weighted sequence of magnetic resonance imaging scans of the brain.Results:A total of 188 patients (mean [SD] age, 67.2 [15.7] years; 98 men [52.1%]) were included in this intention-to-treat analysis. At hospital admission, the median National Institutes of Health Stroke Scale score was 10 (interquartile range [IQR], 6-16) and the median brain infarction volume was 11.4 cm3 (IQR, 3.6-35.8 cm3); 164 patients (87.2%) received intravenous thrombolysis, and 64 patients (34.0%) underwent mechanical thrombectomy. The median increase in brain infarction growth was 0.30 cm3 (IQR, 0.11-0.48 cm3) in the intervention group and 0.37 cm3 (IQR, 0.19-0.55 cm3) in the control group (mean between-group difference on loge-transformed change, -0.07; 95% CI, -0.33 to 0.18; P = .57). An excellent outcome (defined as a score of 0-1 on the 90-day modified Rankin Scale or a score equal to the prestroke modified Rankin Scale score) was observed in 46 of 90 patients (51.1%) in the intervention group and 37 of 91 patients (40.7%) in the control group (P = .12). No significant differences in 90-day mortality were observed between the intervention and control groups (14 of 90 patients; Kaplan-Meier estimate, 15.8% vs 10 of 91 patients; Kaplan-Meier estimate, 10.4%, respectively; P = .45) or with symptomatic intracerebral hemorrhage (4 of 88 patients [4.5%] in both groups; P = .97).Conclusions and relevance:In this study, treatment with remote ischemic perconditioning, during or after reperfusion therapies, had no significant effect on brain infarction volume growth at 24 hours after symptom onset.Trial registration:ClinicalTrials.gov Identifier: NCT02189928.

Primary Outcome Measures is Brain MRI changes of DWI ( Diffusion-Weighted Imaging) brain infarction volume (cc) between baseline (<H6) and day 1 in the 2 groups of patients ( Remote Ischemic Perconditioning and control); Extracted Interventionsis is Lower limb tourniquet Usual care; Conditions is Cerebral Infarction ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Adaptive support ventilation for complete ventilatory support in acute respiratory distress syndrome: a pilot, randomized controlled trial.Background and objective:Low tidal volume ventilation has been shown to improve survival in acute respiratory distress syndrome (ARDS). Adaptive support ventilation (ASV), a closed-loop ventilatory mode, can minimize the work of breathing, and thus potentially improve the outcomes in ARDS. The aim of this pilot, randomized clinical trial was to compare the outcomes of ASV versus volume-cycled ventilation (VCV) in ARDS.Methods:Patients with ARDS were randomly allocated to either ASV or VCV. The primary outcomes were duration of mechanical ventilation, new-onset organ dysfunction and hospital length of stay. The secondary outcomes were ease of use of the ventilator mode (assessed using the visual analogue scale (VAS)), number of daily arterial blood gas analyses, daily requirements of sedative and neuromuscular blockers, and mortality.Results:Forty-eight patients (28 males, 20 females) with ARDS were randomized to receive either ASV (n = 23) or VCV (n = 25) during the study period. The baseline characteristics were almost similar in the two groups. The duration of mechanical ventilation, delta sequential organ failure assessment scores, intensive care unit and hospital stay were comparable in the two groups. The mortality (VCV-36% vs ASV-34.7%), ease of use of mechanical ventilation, daily midazolam and vecuronium doses, and the number of arterial blood gas analyses performed were also similar in the two groups.Conclusions:There was no significant difference in the outcomes of patients with ARDS ventilated with either VCV or ASV in this study.

Primary Outcome Measures is Duration of mechanical ventilation; Extracted Interventionsis is type of mechanical ventilation; Conditions is Respiration, Artificial|Respiratory Distress Syndrome, Adult ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Normal and proton pump inhibitor-mediated gastrin levels in infants 1 to 11 months old.Background:Scant data exist on the normal range of serum gastrin in infants. In phase I and III trials of rabeprazole in gastroesophageal reflux disease, we studied serum gastrin levels in infants 1 to 11 months old, and assessed normal ranges and the effect of acid-suppressive drugs.Methods:Overall, 349 treatment-naïve or treatment-experienced (previously exposed to proton pump inhibitors and/or H2-receptor antagonists) infants with gastroesophageal reflux disease were screened for baseline serum gastrin. Repeat gastrin was monitored at early termination or end of study, allowing assessment of 1 to 8 week daily rabeprazole (5- or 10-mg) treatment on gastrin levels.Results:Median (5%-95% range) baseline gastrin was 118 ng/L (39-315) in the treatment-naïve group (n = 251), driven mostly by high levels (121.5 [48-326] ng/L) in the 1- to <4-month-old subgroup. Treatment-experienced infants (n = 98) had elevated baseline gastrin levels (152 [48-487] ng/L; P = 0.0011) with no clear difference between previously proton pump inhibitor-exposed and H2-receptor antagonist-exposed groups. At the end of study, mean (standard deviation) levels were unchanged from baseline in infants withdrawn from rabeprazole to placebo (124 [94] ng/L), but elevated from baseline in those continuing treatment with 5-mg (245 [151] ng/L) and 10-mg (332 [222] ng/L) rabeprazole during the study.Conclusions:Gastrin levels in treatment-naïve infants were elevated through 8 months of age. Between 8 and 12 months of age, they declined so that the median level was within the upper limit of the normal adult range (<100 ng/L). Previous exposure to acid-suppressive medications and short-term exposure to rabeprazole significantly increased gastrin levels in infants younger than 1 year.

Primary Outcome Measures is Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward); Extracted Interventionsis is Rabeprazole sodium 5 mg Rabeprazole sodium 10 mg Placebo; Conditions is Gastroesophageal Reflux ;Sex is ALL ;Age is CHILD

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Patient-reported outcomes and the association with clinical response in patients with active psoriatic arthritis treated with golimumab: findings through 2 years of a phase III, multicenter, randomized, double-blind, placebo-controlled trial.Objective:To evaluate the effect of golimumab on physical function, health-related quality of life (HRQOL), and productivity in psoriatic arthritis (PsA).Methods:GO-REVEAL was a multicenter, randomized, placebo-controlled study. Adult patients with active PsA (n = 405) received golimumab (50 or 100 mg) or placebo every 4 weeks, with early escape at week 16 (placebo → 50 mg, 50 → 100 mg) or placebo crossover to golimumab 50 mg at week 24. Patient-reported outcomes included physical function (Health Assessment Questionnaire [HAQ] disability index [DI] score), HRQOL (36-item Short Form health survey [SF-36] mental component summary [MCS] and physical component summary [PCS] scores), and productivity (home/school/work). Clinical response was assessed using the 28-joint Disease Activity Score using the C-reactive protein level (DAS28-CRP) and the Psoriasis Area and Severity Index (PASI) score for arthritis and skin symptoms, respectively.Results:At week 24, golimumab-treated patients had significant mean improvements in HAQ DI (0.36), SF-36 (PCS 7.83, MCS 3.84), and productivity (2.24) scores compared with placebo (-0.01, 0.67, -0.60, and 0.08, respectively; P < 0.001 for all). Also, greater proportions of golimumab- than placebo-treated patients had clinically meaningful improvements in HAQ DI (≥0.30) and SF-36 PCS and MCS (≥5) scores at week 24 (P < 0.05). Also at week 24, improvements in DAS28-CRP scores were significantly but moderately correlated with improvements in HAQ DI, SF-36 PCS, and productivity scores. Correlations between these patient-reported outcomes and improvements in PASI, enthesitis, and dactylitis scores were very weak. Improvements in HAQ DI, SF-36, and productivity scores were similar among all groups by week 52 and week 104 when including placebo → golimumab crossover patients.Conclusion:Golimumab-treated patients had significant improvements in physical function, HRQOL, and productivity through week 24; these improvements correlated with clinical improvement in signs and symptoms of peripheral arthritis and were sustained through 2 years.

Primary Outcome Measures is American College of Rheumatology (ACR) 20 Response at Week 14; Extracted Interventionsis is golimumab Placebo; golimumab golimumab; Conditions is Arthritis, Psoriatic ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.RAHelp: an online intervention for individuals with rheumatoid arthritis.Objective:To test an intervention for improving self-management in rheumatoid arthritis (RA) using an online, cognitive-behavioral, self-management group program (RAHelp), with weekly telephone support.Methods:A 2-group, randomized study design was used to compare an intervention for RA versus a waiting-list control condition. The intervention used a secure web site (RAHelp.org) to provide a 10-week program with weekly educational modules for improving self-efficacy in self-management of RA, plus tools for group interaction. Weekly telephone contacts were made to encourage use of program tools and apply newly learned skills. A nationwide convenience sample of 106 adult participants (mean age 50 years, 93% women) was recruited primarily through online advertisements. Main outcome measures included the Arthritis Impact Measurement Scales 2 (affective, physical, role, social, and pain/symptom components), Arthritis Self-Efficacy Scale (ASES), Center for Epidemiologic Studies Depression Scale, Quality of Life Scale (QLS), Rapid Assessment of Disease Activity in Rheumatology, Social Provisions Scale, and University of California, Los Angeles Loneliness Scale 3.Results:Group differences with large and moderate effect sizes (ES) were found immediately postintervention for self-efficacy (ASES; ES 0.92, P = 0.00001) and quality of life (QLS; ES 0.66, P = 0.003), respectively. At 9 months postintervention, differences in self-efficacy (ASES; ES 0.92, P = 0.00001) and quality of life (QLS; ES 0.71, P = 0.004) remained robust.Conclusion:RAHelp appears to have beneficial effects in terms of self-efficacy and quality of life among individuals with RA who are willing to use an online service format.

Primary Outcome Measures is Arthritis Impact Measurement Scales; Extracted Interventionsis is Online Self-Management; Conditions is Rheumatoid Arthritis ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Telephone based cognitive behavioral therapy targeting major depression among urban dwelling, low income people living with HIV/AIDS: results of a randomized controlled trial.This pilot randomized controlled trial evaluated a previously developed manualized telephone based cognitive behavioral therapy (T-CBT) intervention compared to face-to-face (f2f) therapy among low-income, urban dwelling HIV infected depressed individuals. The primary outcome was the reduction of depressive symptoms as measured by the Hamliton rating scale for depression scale. The secondary outcome was adherence to HAART as measured by random telephone based pill counts. Outcome measures were collected by trained research assistants masked to treatment allocation. Analysis was based on intention-to-treat. Thirty-four participants met eligibility criteria and were randomly assigned to receive T-CBT (n = 16) or f2f (n = 18). There was no statistically significant difference in depression treatment outcomes comparing f2f to T-CBT. Within group evaluation demonstrated that both the T-CBT and the f2f psychotherapy groups resulted in significant reductions in depressive symptoms. Those who received the T-CBT were significantly more likely to maintain their adherence to antiretroviral medication compared to the f2f treatment. None of the participants discontinued treatment due to adverse events. T-CBT can be delivered to low-income, urban dwelling HIV infected depressed individuals resulting in significant reductions in depression symptoms and improved adherence to antiretroviral medication.Trial registry:Clinical Trial.gov identifier: NCT01055158.

Primary Outcome Measures is Hamilton Depression Scale (HAM-D); Extracted Interventionsis is Telephone-based CBT Enhanced Usual Care; Conditions is Depression|HIV Infections ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial.Objectives:Growing, small, peripheral, pulmonary nodules in patients at high risk for lung cancer lead to requests for video-assisted thoracoscopic (VATS) resection for pathologic diagnosis. The purpose of this randomized controlled trial was to determine if preoperative localization using percutaneously placed computed tomography (CT)-guided platinum microcoils decreases the need for thoracotomy or VATS anatomic resection (segmentectomy/lobectomy) for diagnosis.Methods:Patients with undiagnosed nodules of 15 mm or less were randomized to either no localization or preoperative microcoil localization. Coils were placed with the distal end deep to the nodule and the superficial end coiled on the visceral pleural surface with subsequent visualization by intraoperative fluoroscopy and VATS. Nodules were removed by VATS wedge excision using endostaplers. The primary outcome was a VATS wedge excision for pathologic diagnosis of the nodule without the need for either thoracotomy or VATS anatomic resection.Results:Sixty patients were randomized and 56 underwent surgery between March 2010 and June 2012. Twenty-nine underwent microcoil localization and 27 did not. The baseline characteristics (age, sex, forced expiratory volume in the first second of expiration, nodule size/depth) were similar. The coil group had a higher rate of successful diagnosis with VATS wedge resection alone (27/29 vs 13/27; P < .001), decreased operative time to nodule excision (37 ± 39 vs 100 ± 67 minutes; P < .001), and reduced stapler firings (3.7 ± 2.0 vs 5.9 ± 31; P = .003) with no difference in total costs. Pathologic diagnoses included 14 benign nodules, 32 primary lung malignancies, and 10 metastases. There were no clinically significant complications related to the coil placement or wedge resection.Conclusions:Preoperative CT-guided microcoil localization decreases the need for thoracotomy or VATS anatomic resection for the diagnosis of small peripheral pulmonary nodules.

Primary Outcome Measures is conversion to open thoracotomy; Extracted Interventionsis is Platinum microcoil; Conditions is Lung Cancer ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with moderately reduced left ventricular ejection fraction and a narrow QRS duration: study rationale and design.Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. The FIX-HF-5 study was a prospective randomized study comparing CCM plus optimal medical therapy (OMT) to OMT alone that included 428 New York Heart Association (NYHA) functional class III or IV heart failure patients with ejection fraction (EF) ≤45% according to core laboratory assessment. The study met its primary safety end point, but did not reach its primary efficacy end point: a responders analysis of changes in ventilatory anaerobic threshold (VAT). However, in a prespecified subgroup analysis, significant improvements in primary and secondary end points, including the responder VAT end point, were observed in patients with EFs ranging from 25% to 45%, who constituted about one-half of the study subjects. We therefore designed a new study to prospectively confirm the efficacy of CCM in this population. A hierarchic bayesian statistical analysis plan was developed to take advantage of the data already available from the first study. In addition, based on technical difficulties encountered in reliably quantifying VAT and the relatively large amount of nonquantifiable studies, the primary efficacy end point was changed to peak VO2, with significant measures incorporated to minimize the influence of placebo effect. In this paper, we provide the details and rationale of the FIX-HF-5C study design to study CCM plus OMT compared with OMT alone in subjects with normal QRS duration, NYHA functional class III or IV, and EF 25%-45%. This study is registered on www.clinicaltrials.gov with identifier no. NCT01381172.

Primary Outcome Measures is Peak VO2; Extracted Interventionsis is Optimizer System No intervention; Conditions is NYHA Class III Heart Failure|NYHA Class IV Heart Failure ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Triple combination of insulin glargine, sitagliptin and metformin in type 2 diabetes: the EASIE post-hoc analysis and extension trial.Aim:We examined the effects of adding glargine to metformin-sitagliptin (MS+G) or sitagliptin to metformin-glargine (MG+S) therapy in type 2 diabetic persons uncontrolled after 24-week MS or MG dual therapy.Methods:Subjects with A1c≥7% on MS or MG treatment were respectively given glargine (0.2U/kg starting dose) or sitagliptin (100mg daily) for 12weeks. The primary endpoint was number of subjects attaining A1c goal defined as <7%.Results:After receiving 24-week MS or MG dual therapy in the original EASIE Study, 42% (104/248) on MS and 68% (152/224) on MG attained A1c<7% (p<0.0001). The reduction in A1c was negatively associated with baseline fasting blood glucose (FBG) only in the MG group. Reduction in A1c was not related to baseline postprandial blood glucose (PPBG) in either the MG or MS group. Amongst 194 eligible patients, 57.7% (n=111) entered the 12-week extension trial [MS+G:74/131, 57.3%; MG+S:37/63, 58.7%) with 55 (51.9%) subjects attaining goal [MS+G:59.2%; MG+S:37.1%] at week 12. The final insulin dosage was similar in both groups [MS+G: 0.46U/kg; MG+S: 0.45U/kg] with a higher rate of hypoglycemia in the MG+S (6.5 events/patient-year) than the MS+G group (3.2 events/patient-year), although neither group had severe hypoglycemia.Conclusion:In metformin-treated type 2 diabetes patients, high fasting BG predicted greater A1c reductions with the addition of glargine, but not with sitagliptin. In subjects uncontrolled with 6-month dual therapy of MS or MG, 50% attained A1c<7% with triple therapy of MS+G or MG+S in 12weeks. The increased rate of hypoglycemia with MG+S (but not with MS+G) underlines the need to take measures to avoid the hypoglycemia.

Primary Outcome Measures is HbA1c: Change From Baseline to Study Endpoint; Extracted Interventionsis is Insulin Glargine Sitagliptin Metformin; Conditions is Diabetes Mellitus, Type 2 ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration.Summary statement:Intravitreal high dose (2 mg) ranibizumab may lead to quicker resolution of choroidal neovascularization (CNV) and associated retinal pigment epithelial detachment in eyes with exudative age-related macular degeneration, although it may possibly correlate with RPE tears in certain cases.Purpose:This prospective study compared the outcomes of 0.5 vs 2.0 mg intravitreal ranibizumab injections (RI) for treating vascularized pigment epithelial detachment (vPED) due to age-related macular degeneration.Methods:Patients with vPED were randomized to receive 2.0 vs 0.5 mg RI monthly for 12 months or for 4 months and then repeated on a pro-re nata basis. Optical coherence tomography, fundus photography, and fluorescein and indocyanine-green angiography were obtained at baseline and subsequent specific intervals. Outcome measures were best-corrected standardized visual acuities, central 1-mm thickness, surface area (SA), greatest linear diameter (GLD), heights (PED and CNV), and amount of subretinal fluid (SRF) and cystoid macular edema (CME).Results:Both groups yielded reductions of the central 1-mm thickness, PED and CNV SA and PED height and GLD, SRF, and CME. Vision improvement and reduction in SRF and PED height occurred earlier for eyes receiving the 2.0 mg dose. Cataract progression was similar but RPE tears developed more often with the 2.0 mg dose.Conclusions:There were similar visual and anatomical outcomes at the end of the study; however, the higher dose yielded more rapid reductions and more complete resolution of the PED, although there was possible increased tendency for an RPE tear with the higher dose.

Primary Outcome Measures is Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 12 months.; Extracted Interventionsis is Ranibizumab Ranibizumab Ranibizumab Ranibizumab; Conditions is Retinal Pigment Epithelial Detachment ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension.Japanese patients with uncontrolled essential hypertension received single-blind losartan 50 mg/hydrochlorothiazide 12.5 mg (L50/H12.5) for 8 weeks. Patients whose blood pressure (BP) remained uncontrolled were randomized double-blind to fixed-dose losartan 50 mg/hydrochlorothiazide 12.5 mg/amlodipine 5 mg (L50/H12.5/A5) or L50/H12.5 for 8 weeks followed by open-label L50/H12.5/A5 for 44 weeks. Adverse events were assessed. After 8 weeks, diastolic and systolic BP were reduced significantly more with L50/H12.5/A5 versus L50/H12.5 (both p < 0.001). Mean changes in diastolic and systolic BP were sustained for 44 weeks. L50/H12.5/A5 was well-tolerated and improved BP significantly versus L50/H12.5 in Japanese patients with uncontrolled essential hypertension.

Primary Outcome Measures is Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period; Extracted Interventionsis is L50/H12.5/A5 L50/H12.5 Placebo to L50/H12.5/A5 Placebo to L50/H12.5; Conditions is Hypertension ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Sofosbuvir and ribavirin prevent recurrence of HCV infection after liver transplantation: an open-label study.Background & aims:Patients with detectable hepatitis C virus (HCV) RNA at the time of liver transplantation universally experience recurrent HCV infection. Antiviral treatment before transplantation can prevent HCV recurrence, but existing interferon-based regimens are poorly tolerated and are either ineffective or contraindicated in most patients. We performed a trial to determine whether sofosbuvir and ribavirin treatment before liver transplantation could prevent HCV recurrence afterward.Methods:In a phase 2, open-label study, 61 patients with HCV of any genotype and cirrhosis (Child-Turcotte-Pugh score, ≤7) who were on waitlists for liver transplantation for hepatocellular carcinoma, received up to 48 weeks of sofosbuvir (400 mg) and ribavirin before liver transplantation. The primary end point was the proportion of patients with HCV-RNA levels less than 25 IU/mL at 12 weeks after transplantation among patients with this HCV-RNA level at their last measurement before transplantation.Results:Sixty-one patients received sofosbuvir and ribavirin, and 46 received transplanted livers. The per-protocol efficacy population consisted of 43 patients who had HCV-RNA level less than 25 IU/mL at the time of transplantation. Of these 43 patients, 30 (70%) had a post-transplantation virologic response at 12 weeks, 10 (23%) had recurrent infection, and 3 (7%) died (2 from nonfunction of the primary graft and 1 from complications of hepatic artery thrombosis). Of all 61 patients given sofosbuvir and ribavirin, 49% had a post-transplantation virologic response. Recurrence was related inversely to the number of consecutive days of undetectable HCV RNA before transplantation. The most frequently reported adverse events were fatigue (in 38% of patients), headache (23%), and anemia (21%).Conclusions:Administration of sofosbuvir and ribavirin before liver transplantation can prevent post-transplant HCV recurrence. ClinicalTrials.gov: NCT01559844.

Primary Outcome Measures is Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12; Extracted Interventionsis is Sofosbuvir Ribavirin; Conditions is Hepatitis C|Hepatocellular Carcinoma ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Optimisation of movement detection and artifact removal during laser speckle contrast imaging.Introduction:Laser speckle contrast imaging (LSCI) allows an easy non-contact monitoring of the cutaneous blood flow (CBF), but is highly sensitive to movement artifacts (ARTm). Subtraction of a signal recorded on an adhesive opaque surface (AOS) close to the area of interest was reported as a mean of reducing noise from the raw skin LSCI (LSCIsk) signal, provided an individual calibration was performed. Assuming that AOS=a·CBF+b·ARTm, an ideal patch should completely block the light reflection due to CBF and thus be insensitive to skin blood flow changes ("a"~0), while keeping a reflection signal amplitude similar to the one from the skin in case of artifact ("b"~1). This ideal AOS has not been determined and may discriminate flow from movements during LSCI recordings.Materials and methods:We tested different AOSs to determine their "a" and "b" parameters in 35 and 34 healthy volunteers, respectively. The AOS surface providing results as close as possible to an ideal AOS, was used for a point-by-point de-noising of post occlusive reactive hyperemia (PORH) on two different days in 15 new subjects. Correlation of raw, smoothed (average smoothing over 1s intervals) and denoised signals was tested through a cross-correlation analysis of the two POHR tests.Results:The optimal "a" and "b" values were obtained with a homemade bilayer adhesive patch (a=0.06±0.05 and b=1.03±0.17) whereas other tested AOS had "a" values ranging from 0.05 to 0.23 and "b" values ranging from 2.69 to 3.82. Using the bilayer adhesive patch the cross-correlation between the two tests of POHR increased from 0.330±0.128 for raw, to 0.461±0.168 for smoothed and 0.649±0.128 for denoised signals respectively (p<0.05 from raw coefficients).Conclusion:The home-made bilayer adhesive seems the optimal AOS for the removal of ARTm from the LSCIsk signal while respecting CBF signal. This specific AOS allows for an efficient de-noising of LSCI measurements without the need for individual calibration.

Primary Outcome Measures is nan; Extracted Interventionsis is nan; Conditions is Microvascular Function ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Stereopsis results at 4.5 years of age in the infant aphakia treatment study.Purpose:To determine whether stereopsis of infants treated for monocular cataracts varies with the type of optical correction used.Design:Randomized prospective clinical trial.Methods:The Infant Aphakia Treatment Study randomized 114 patients with unilateral cataracts at age 1-7 months to either primary intraocular lens (IOL) or contact lens correction. At 4.5 years of age a masked examiner assessed stereopsis on these patients using 3 different tests: (1) Frisby; (2) Randot Preschool; and (3) Titmus Fly.Results:Twenty-eight patients (25%) had a positive response to at least 1 of the stereopsis tests. There was no statistically significant difference in stereopsis between the 2 treatment groups: Frisby (contact lens, 6 [11%]; IOL, 7 [13%]; P = .99), Randot (contact lens, 3 [6%]; IOL, 1 [2%]; P = .62), or Titmus (contact lens, 8 [15%]; IOL, 13 [23%]; P = .34). The median age at surgery for patients with stereopsis was younger than for those without stereopsis (1.2 vs 2.4 months; P = .002). The median visual acuity for patients with stereopsis was better than for those without stereopsis (20/40 vs 20/252; P = .0003).Conclusion:The type of optical correction did not influence stereopsis outcomes. However, 2 other factors did: age at surgery and visual acuity in the treated eye at age 4.5 years. Early surgery for unilateral congenital cataract and the presence of visual acuity better than or equal to 20/40 appear to be more important than the type of initial optical correction used for the development of stereopsis.

Primary Outcome Measures is Visual Acuity; Extracted Interventionsis is Contact lens correction of aphakia Intraocular lens implantation; Conditions is Congenital Cataract ;Sex is ALL ;Age is CHILD

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Put a face to a name: a randomized controlled trial evaluating the impact of providing clinician photographs on inpatients' recall.Background:Inpatients are visited by many health care providers daily; many cannot remember the name of even one member of their clinical care team. We provided inpatients with photographs of their clinicians and evaluated the impact on patient recall and communication with their health care providers.Methods:A concealed allocation, randomized controlled trial (ClinicalTrials.gov NCT01658644) was conducted between September 2012 and April 2013 in the general internal medicine wards of a large teaching hospital in Toronto, Canada. Consenting patients were randomized into 3 groups: the control group received the current standard of care; the second group received handouts with the names and roles of their clinical care team; and the third group received handouts with the names, roles, and photographs of their clinical care team. Before discharge, patients completed a survey on their ability to recall their clinicians and were asked to rate the quality of communication with their care team.Results:Of the 186 patients (mean age 61 years, female = 44%) who completed surveys (control n = 60; names n = 65; photos n = 61), those receiving photos in the handout correctly identified significantly more clinicians by photograph (P = .001) and recalled more names (P = .002) than patients assigned to the control group. Regarding the perceived quality of communication, the results did not show differences between the control and intervention groups.Conclusion:In this era of patient-centered care, providing patients with more information about who is directly involved with their health care appears to be warranted.

Primary Outcome Measures is Patient's memory recall of their clinical care team; Extracted Interventionsis is Provision of Clinical Care Handout; Conditions is Effects of Photographic Aids (Photos of Faces) on Patient Recall of Their Clinical Care Team|Effects of Photographic Aids (Photos of Faces) on Clinician-patient Communication|Effects of Photographic Aids (Photos of Faces) on Overall Patient Satisfaction ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Evaluation of functional health and well-being in patients receiving levomilnacipran ER for the treatment of major depressive disorder.Introduction:Levomilnacipran extended-release (ER) is an FDA-approved serotonin norepinephrine reuptake inhibitor (SNRI) for treating major depressive disorder (MDD). SF-36v2 Health Survey outcomes from a Phase III, randomized, double-blind, placebo-controlled study (NCT00969709) were evaluated.Methods:Prospective and post hoc analyses of SF-36 Mental and Physical Component Summaries (MCS, PCS), and individual domains compared pooled levomilnacipran ER doses (40, 80, 120 mg/day) with placebo. Patients (18-65 years) had MDD, depressive episode ≥ 8 weeks, and Montgomery-Åsberg Depression Rating Scale total score ≥ 30. SF-36 score changes from baseline to Week 8 were analyzed using ANCOVA and the observed cases approach (Intent-to-Treat [ITT] Population). Minimally important differences (MID) evaluated clinical relevance.Results:Baseline MCS scores reflected marked mental deficits in the ITT Population (levomilnacipran ER = 529; placebo = 175). MCS change at Week 8 was significantly greater for levomilnacipran ER than placebo (LSMD [SE] = 4.8 [1.5]; P = 0.0011); MID exceeded the 3-point threshold. Baseline PCS scores suggested minimal physical deficits; no between-group difference at Week 8 was noted. LSMD was nominally statistically significant (P < 0.05) for levomilnacipran ER versus placebo in 5 domains (General Health [2.44; P = 0.0010], Vitality [2.48; P = 0.0307], Social Functioning [3.25; P = 0.0097], Role-Emotional [3.38; P = 0.0078], Mental Health [4.34; P = 0.0005]); changes in Vitality, Social Functioning, and Mental Health exceeded MID.Limitations:The trial was limited by short duration; analyses were post hoc and adjustments were not made for multiplicity.Conclusion:Statistically significant and clinically meaningful improvement on the MCS and several individual domains suggest overall and dimensional improvement in health-related functioning for patients with MDD treated with levomilnacipran ER versus placebo.

Primary Outcome Measures is Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score; Extracted Interventionsis is Levomilnacipran ER Levomilnacipran ER Levomilnacipran ER Placebo; Conditions is Major Depressive Disorder ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.The SAFETY Program: a treatment-development trial of a cognitive-behavioral family treatment for adolescent suicide attempters.The purpose of this article is to describe feasibility, safety, and outcome results from a treatment development trial of the SAFETY Program, a brief intervention designed for integration with emergency services for suicide-attempting youths. Suicide-attempting youths, ages 11 to 18, were enrolled in a 12-week trial of the SAFETY Program, a cognitive-behavioral family intervention designed to increase safety and reduce suicide attempt (SA) risk (N = 35). Rooted in a social-ecological cognitive-behavioral model, treatment sessions included individual youth and parent session-components, with different therapists assigned to youths and parents, and family session-components to practice skills identified as critical in the pathway for preventing repeat SAs in individual youths. Outcomes were evaluated at baseline, 3-month, and 6-month follow-ups. At the 3-month posttreatment assessment, there were statistically significant improvements on measures of suicidal behavior, hopelessness, youth and parent depression, and youth social adjustment. There was one reported SA by 3 months and another by 6 months, yielding cumulative attempt rates of 3% and 6% at 3 and 6 months, respectively. Treatment satisfaction was high. Suicide-attempting youths are at high risk for repeat attempts and continuing mental health problems. Results support the value of a randomized controlled trial to further evaluate the SAFETY intervention. Extension of treatment effects to parent depression and youth social adjustment are consistent with our strong family focus and social-ecological model of behavior change.

Primary Outcome Measures is Hospitalization; Extracted Interventionsis is SAFETY Enhanced usual care; Conditions is Suicide ;Sex is ALL ;Age is CHILD, ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.nan

Primary Outcome Measures is Median survival; Extracted Interventionsis is cisplatin gemcitabine hydrochloride adjuvant therapy conventional surgery neoadjuvant therapy radiation therapy; Conditions is Pancreatic Cancer ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Cognitive outcome of early intervention in preterms at 7 and 9 years of age: a randomised controlled trial.Objective:Examine the effect of an early intervention programme on cognitive outcome at 7 and 9 years in children with birth weight (BW) <2000 g.Design:A randomised controlled trial of a modified version of the Mother-Infant Transaction Program.Setting:A single tertiary neonatal unit.Patients:146 infants were randomised into a preterm control group (74) or a preterm intervention group (72).Interventions:The intervention consisted of eight sessions shortly before discharge and four home visits by specially trained nurses focusing on the infants' unique characteristics, temperament, developmental potential and the interaction between infants and parents.Main outcome measures:Outcomes were assessed with the Wechsler Intelligence Scale for Children (WISC-III).Results:Mean BWs were 1396 (429) g in the intervention group and 1381(436) g in the control group. After adjusting for the possible clustering effects of twin pairs and maternal education, there were no significant differences in WISC-III scores at age 7 or 9. The mean difference was 4.1 points (95% CI -1.5 to 9.8 points) in favour of the intervention group at 7 years and 2.2 points (95% CI -3.4 to 7.6 points) at 9 years. At 7 years, a 6.8 points difference in the Verbal Comprehension Index (95% CI 0.5 to 13.0 points) was found in favour of the intervention group. Loss to follow-up at age 7 and 9 was 11% and 14%, respectively.Conclusions:This intervention programme did not have a sustained significant effect on overall cognitive outcomes in preterm children at age 7 and 9.Trial registration number:The trial has been registered at http://www.clinicaltrials.gov (identifier NCT00222456).

Primary Outcome Measures is Cognitive and behavioral outcome|Parenting Stress; Extracted Interventionsis is Sensitizing parents; Conditions is Preterm Infants|Parenting Stress ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.A randomized, triple-masked, active-controlled investigation of the relative effects of dose, concentration, and infusion rate for continuous popliteal-sciatic nerve blocks in volunteers.Background:It remains unknown whether local anaesthetic dose is the only factor influencing continuous popliteal-sciatic nerve block effects, or whether concentration, volume, or both exert an influence as well.Methods:Bilateral sciatic catheters were inserted in volunteers (n=24). Catheters were randomly assigned to ropivacaine of either 0.1% (8 ml h(-1)) or 0.4% (2 ml h(-1)) for 6 h. The primary endpoint was the tolerance to transcutaneous electrical stimulation within the tibial nerve distribution at hour 6. Secondary endpoints included current tolerance at other time points and plantar flexion maximum voluntary isometric contraction (22 h total).Results:At hour 6, tolerance to cutaneous stimulation for limbs receiving 0.1% ropivacaine was [mean (standard deviation)] 27.0 (20.2) vs26.9 (20.4) mA for limbs receiving 0.4% [estimated mean difference 0.2 mA; 90% confidence interval (CI) -8.2 to 8.5; P=0.02 and 0.03 for lower and upper boundaries, respectively]. Because the 90% CI fell within the prespecified tolerance ±10 mA, we conclude that the effect of the two concentration/volume combinations were equivalent. Similar negative findings were found for the secondary outcomes.Conclusions:For continuous popliteal-sciatic nerve blocks, we found no evidence that local anaesthetic concentration and volume influence block characteristics, suggesting that local anaesthetic dose (mass) is the primary determinant of perineural infusion effects in this anatomic location. These findings suggest that for ambulatory perineural local anaesthetic infusion-for which there is usually a finite local anaesthetic reservoir-decreasing the basal rate while increasing the local anaesthetic concentration may allow for increased infusion duration without compromising postoperative analgesia.Clinical trial registration:NCT01898689.

Primary Outcome Measures is Maximum Tolerance to Transcutaneous Electrical Stimulation; Extracted Interventionsis is Ropivacaine 0.1% Ropivacaine 0.4%; Conditions is Relatively Healthy Volunteers ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Increased exposure of norethindrone in HIV+ women treated with ritonavir-boosted atazanavir therapy.Objective:Pharmacokinetics of norethindrone in combination oral contraceptive regimen are well described among HIV+ women treated with ritonavir-boosted protease inhibitor therapies; however, such characterization is lacking in women using progestin-only contraception. Our objective is to characterize pharmacokinetics of norethindrone in HIV+ women using ritonavir-boosted atazanavir treatment during progestin-only contraceptive regimens.Study design:An open-label, prospective, nonrandomized trial to characterize the pharmacokinetics of norethindrone in HIV+ women receiving ritonavir-boosted atazanavir (n=10; treatment group) and other antiretroviral therapy known to not alter norethindrone levels (n=17; control group) was conducted. Following informed consent, women were instructed to take a single daily fixed oral dose of 0.35 mg norethindrone and 300 mg/100 mg atazanavir/ritonavir for 22 days. On day 22, serial blood samples were collected by venous catheter at 0, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h. Whole blood was processed to collect serum and stored at -20°C until later analysis using radioimmunoassay. Pharmacokinetic parameters were estimated using noncompartmental method.Results:In the treatment group, compared to the control group, an increase in area under the curve₀₋₂₄ (16.69 h*ng/mL vs. 25.20 h*ng/mL; p<.05) and maximum serum concentration (2.09 ng/mL vs. 3.19 ng/mL; p<.05), decrease (25%-40%) in apparent volume of distribution and apparent clearance, and unaltered half-life were observed.Conclusion(s):Our findings suggest that progestin-only contraceptives, unlike combination oral contraceptives, benefit from drug-drug interaction and achieve higher levels of exposure. Further studies are needed to establish whether pharmacokinetic interaction leads to favorable clinical outcomes.Implications:Norethindrone-based progestin-only contraceptives, unlike combination oral contraceptives, exhibit greater drug exposure when co-administered with ritonavir-boosted atazanavir regimen and thus may not warrant a category 3 designation by the World Health Organization. Prospective studies are needed to confirm whether pharmacokinetic interaction results in favorable clinical outcomes.

Primary Outcome Measures is AUC Norethindrone; Extracted Interventionsis is Norethindrone acetate; Conditions is Pregnancy|HIV|AIDS ;Sex is FEMALE ;Age is ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Docosahexaenoic acid-enriched canola oil increases adiponectin concentrations: a randomized crossover controlled intervention trial.Background and aims:Little is known about the effect of various dietary fatty acids on pro- and anti-inflammatory processes. We investigated the effect of 5 oils containing various amounts of alpha-linolenic acid (ALA), linoleic acid (LA), oleic acid (OA) and docosahexaenoic acid (DHA) on plasma inflammatory biomarkers and expression levels of key inflammatory genes and transcription factors in whole blood cells.Methods and results:In a randomized, crossover controlled nutrition intervention, 114 adult men and women with abdominal obesity and at least one other criterion for the metabolic syndrome consumed 5 experimental isoenergetic diets for 4 weeks each, separated by 4-week washout periods. Each diet provided 60 g/3000 kcal of different oils: 1) control corn/safflower oil blend (CornSaff; LA-rich), 2) flax/safflower oil blend (FlaxSaff; ALA-rich), 3) conventional canola oil (Canola; OA-rich), 4) high oleic canola oil (CanolaOleic; highest OA content), 5) DHA-enriched high oleic canola oil (CanolaDHA; OA- and DHA-rich). Gene expression in whole blood cells was assessed in a subset of 62 subjects. CanolaDHA increased plasma adiponectin concentrations compared with the control CornSaff oil treatment (+4.5%, P = 0.04) and FlaxSaff (+6.9%, P = 0.0008). CanolaDHA also reduced relative expression levels of interleukin (IL)1B compared with CornSaff and Canola (-11% and -13%, respectively, both P = 0.03). High-sensitivity C-reactive protein concentrations were lower after Canola than after FlaxSaff (-17.8%, P = 0.047).Conclusion:DHA-enriched canola oil exerts anti-inflammatory effects compared with polyunsaturated fatty acids from plant sources.

Primary Outcome Measures is Change in endothelial function; Extracted Interventionsis is Corn and safflower oil Canola oil High oleic acid canola oil DHA enriched high oleic acid canola oil Flax and safflower oil; Conditions is Metabolic Syndrome ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Costs of repair of abdominal aortic aneurysm with different devices in a multicenter randomized trial.Objective:Prior analysis in the Open vs Endovascular Repair Veterans Affairs (VA) Cooperative Study (CSP #498) demonstrated that survival, quality of life, and total health care costs are not significantly different between the open and endovascular methods of repair of abdominal aortic aneurysm. The device is a major cost of this method of repair, and the objective of this study was to evaluate the costs of the device, abdominal aortic aneurysm repair, and total health care costs when different endograft systems are selected for the endovascular repair (EVR). Within each selected system, EVR costs are compared with open repair costs.Methods:The study randomized 881 patients to open (n = 437) or EVR (n = 444). Device selection was recorded before randomization; therefore, open repair controls were matched to each device cohort. Data were excluded for two low-volume devices, implanted in only 13 individuals, leaving 423 control and 431 endovascular patients: 166 Zenith (Cook Medical, Bloomington, Ind), 177 Excluder (W. L. Gore & Associates, Flagstaff, Ariz), and 88 AneuRx (Medtronic, Minneapolis, Minn). Mean device, hospitalization, and total health care costs from randomization to 2 years were compared. Health care utilization data were obtained from patients and national VA and Medicare data sources. VA costs were determined using methods previously developed by the VA Health Economics Resource Center. Non-VA costs were obtained from Medicare claims data and billing data from the patient's health care providers.Results:Implant costs were 38% of initial hospitalization costs. Mean device (range, $13,600-$14,400), initial hospitalization (range, $34,800-$38,900), and total health care costs at 2 years in the endovascular (range, $72,400-$78,200) and open repair groups (range, $75,600-$82,100) were not significantly different among device systems. Differences between endovascular and corresponding open repair cohorts showed lower mean costs for EVR (range, $3200-$8300), but these were not statistically different.Conclusions:The implant costs of endovascular aneurysm repair are substantial. When evaluating total health care system expenditures, there is large individual variability in costs, and there is no significant difference at 2 years among systems or when an individual system is compared with open repair.

Primary Outcome Measures is All-cause Mortality; Extracted Interventionsis is Endovascular Repair Standard Open Repair; Conditions is Aortic Aneurysm ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Investigation of change in cardinal symptoms of chronic rhinosinusitis after surgical or ongoing medical management.Background:Chronic rhinosinusitis (CRS) has been defined as inflammation of the paranasal sinuses lasting at least 12 weeks with corresponding 2 or more "cardinal symptoms" that include: (1) nasal obstruction; (2) thick nasal discharge; (3) facial pain/pressure; and (4) reduction or loss of sense of smell. Although prior studies have investigated symptoms of CRS after sinus surgery, none have compared the outcomes of these specific symptoms to ongoing medical therapy.Methods:Patients with CRS were prospectively enrolled into a multi-institutional, comparative effectiveness, cohort study. Subjects elected either continued medical management or endoscopic sinus surgery (ESS). Baseline characteristics and objective clinical findings were collected. Cardinal symptoms of CRS were operationalized by 4 questions on the 22-item Sino-Nasal Outcome Test (SNOT-22). Symptom improvement was evaluated in subjects with at least 6-month follow-up.Results:A total of 342 subjects were enrolled, with 69 (20.2%) electing continued medical management, whereas 273 (79.8%) elected ESS. Subjects electing surgical therapy were more likely to have a higher baseline aggregate SNOT-22 score (44.3 (18.9) vs 53.6 (18.8); p < 0.001). All subjects improved across all cardinal symptoms; however, subjects undergoing ESS were significantly more likely (p ≤ 0.013) to experience improvement in thick nasal discharge (odds ratio [OR] = 4.36), facial pain/pressure (OR = 3.56), and blockage/congestion of nose (OR = 2.76). Subjects with nasal polyposis were significantly more likely to report complete resolution of smell/taste following ESS compare to medical management (23.8% vs 4.0%; p = 0.026).Conclusion:Across a large population, surgical management is more effective at resolving the cardinal symptoms of CRS than ongoing medical management with the exception of sense of smell/taste.

Primary Outcome Measures is Disease-specific quality of life; Extracted Interventionsis is nan; Conditions is Chronic Rhinosinusitis ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Early preventive exercises versus usual care does not seem to reduce trismus in patients treated with radiotherapy for cancer in the oral cavity or oropharynx: a randomised clinical trial.Purpose:In head and neck cancer patients undergoing curative radiotherapy, we investigated the benefits and harms of an early exercise regime on trismus.Material and methods:Patients with head and neck cancer undergoing radiotherapy were centrally randomised to exercises 5-6 times for 45 minutes during and after radiotherapy supervised by a physiotherapist in addition to usual care versus usual care alone. The primary outcome was change in maximal interincisor distance (MID) measured at 5 and 12 months. Secondary outcomes were change in cervical ranges of motion, tissue tightness, and health-related quality of life. Mixed model analysis of repeated measures adjusted for tumour size and operation was conducted to assess the effect of early preventive exercises across time periods.Results:Of the 100 patients included, two patients withdrew and one died before the onset of radiotherapy. The unadjusted mean difference in MID at 12 months after having completed radiotherapy was 0.83 mm (95% confidence interval (CI) -3.64-5.29, p = 0.71) in the exercise intervention group compared with the control group. When adjusted for operation and tumour size, the effect of the exercise intervention on mean MID from baseline to 12-month follow-up was 5.92 mm (95% CI -0.48-12.33, p = 0.07). Of the secondary outcomes, cervical rotation showed a statistically significant deterioration in the exercise group compared with the control group (p = 0.01). No significant effects were observed on the other secondary outcomes.Conclusions:In patients with cancer in the oral cavity or oropharynx, early supervised exercises combined with self-care treatment focusing on mobility exercises to reduce trismus do not seem to provide additional beneficial effects compared with usual care during curative radiotherapy.

Primary Outcome Measures is The amplitude of mouth opening; Extracted Interventionsis is physiotherapy; Conditions is Oral Cavity Carcinoma|Oropharyngeal Cancer|Adverse Effect of Radiation Therapy|Trismus ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Health economic analysis of ticagrelor in patients with acute coronary syndromes intended for non-invasive therapy.Objective:To investigate the cost effectiveness of ticagrelor versus clopidogrel in patients with acute coronary syndromes (ACS) in the Platelet Inhibition and Patient Outcomes (PLATO) study who were scheduled for non-invasive management.Methods:A previously developed cost effectiveness model was used to estimate long-term costs and outcomes for patients scheduled for non-invasive management. Healthcare costs, event rates and health-related quality of life under treatment with either ticagrelor or clopidogrel over 12 months were estimated from the PLATO study. Long-term costs and health outcomes were estimated based on data from PLATO and published literature sources. To investigate the importance of different healthcare cost structures and life expectancy for the results, the analysis was carried out from the perspectives of the Swedish, UK, German and Brazilian public healthcare systems.Results:Ticagrelor was associated with lifetime quality-adjusted life-year (QALY) gains of 0.17 in Sweden, 0.16 in the UK, 0.17 in Germany and 0.13 in Brazil compared with generic clopidogrel, with increased healthcare costs of €467, €551, €739 and €574, respectively. The cost per QALY gained with ticagrelor was €2747, €3395, €4419 and €4471 from a Swedish, UK, German and Brazilian public healthcare system perspective, respectively. Probabilistic sensitivity analyses indicated that the cost per QALY gained with ticagrelor was below conventional threshold values of cost effectiveness with a high probability.Conclusions:Treatment of patients with ACS scheduled for 12 months' non-invasive management with ticagrelor is associated with a cost per QALY gained below conventional threshold values of cost effectiveness compared with generic clopidogrel.Trial registration number:NCT000391872.

Primary Outcome Measures is Participants With Any Event From the Composite of Death From Vascular Causes; Extracted Interventionsis is Ticagrelor Clopidogrel; Conditions is Acute Coronary Syndrome ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Color Doppler analysis of uterine, spiral, and intraovarian artery blood flow before and after treatment with cabergoline in hyperprolactinemic patients.Prolactin (PRL) may have stimulatory effects on vascular resistance. We aimed to analyze uterine, spiral, and intraovarian artery blood flow by Doppler ultrasonography in hyperprolactinemic patients prior to and after treatment with cabergoline. The study was conducted in Sisli Etfal Training and Research Hospital gynecology outpatient clinic between 1 March 2010 and 30 September 2011. Twenty-four women with symptomatic hyperprolactinemia in reproduction age were included in the study. All hyperprolactinemic patients were studied prior to and following the suppression of circulating PRL levels by cabergoline. Patients were examined by standard B-mod and color transvaginal ultrasonography. Pulsality index (PI), resistance index (RI), and systolic/diastolic ratio (S/D) were recorded. The median PRL value was 86 (62-120) ng/ml before treatment and 4.0 (2.5-6.4) ng/ml after the treatment (p < 0.001). We found a significant association among PRL, uterine, spiral, and intraovarian artery RI with linear regression analysis (p < 0.001 for all three arteries). Uterine, spiral, and intraovarian artery PI (p = 0.021, p < 0.001, and p < 0.001, respectively) and RI (p = 0.001, p < 0.001, and p < 0.001, respectively) significantly decreased after cabergoline treatment. In conclusion, this is a pilot study which shows for the first time that PRL increases the uterine, endometrial, and intraovarian vascular resistance and cabergoline reverses this effect.

Primary Outcome Measures is th effect of prolactin vascular flow and resistance; Extracted Interventionsis is cabergoline treatment; Conditions is Adverse Reaction to Other Drugs and Medicines ;Sex is FEMALE ;Age is ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.Objective:Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure.Design:Prospective, randomized, crossover, pilot clinical trial (NCT01562340).Setting:The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area.Subjects:Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period.Intervention:Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily.Main outcome measures:The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure.Results:Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production.Conclusions:Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress nor affect predialysis blood pressure.

Primary Outcome Measures is Markers of oxidative stress; Extracted Interventionsis is Pomegranate juice Pomegranate fruit extract; Conditions is End Stage Renal Disease|Cardiovascular Disease|Inflammation ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Prophylactic peritoneal dialysis catheter does not decrease time to achieve a negative fluid balance after the Norwood procedure: a randomized controlled trial.Objective:Infants and children who undergo cardiopulmonary bypass and cardiac surgery are at risk of postoperative fluid overload. Peritoneal dialysis catheter (PDC) and peritoneal dialysis are reported to be effective means of postoperative fluid management. We sought to test the hypothesis that PDC insertion in the operating room at the time of Norwood palliation would decrease the time to achieve a negative fluid balance in a group of neonates with hypoplastic left heart syndrome.Methods:A single center randomized controlled trial was performed. We randomized neonates with hypoplastic left heart syndrome to prophylactic PDC, with or without dialysis, or standard care (ie, no PDC).Results:Twenty-two neonates were included; 10 were randomized to PDC and 12 were randomized to standard care. The mean time to first postoperative negative fluid balance was 2.70 ± 1.06 days for the prophylactic PDC group and 2.67 ± 0.65 days for the standard care group (P = .93). There was no difference between the 2 groups in time to lactate ≤ 2 mmol/L, maximum vasoactive-inotrope score on postoperative days 2 to 5, time to sternal closure, time to first extubation, modified clinical outcome score, or hospital length of stay. Twenty-one patients (95%) survived to hospital discharge. Four patients randomized to prophylactic PDC had 1 or more serious adverse events compared with no patients in the standard care group (P = .03).Conclusions:Prophylactic PDC, with or without dialysis, did not decrease the time to achieve a negative fluid balance after the Norwood procedure, did not alter physiological variables postoperatively, and was associated with more severe adverse events.

Primary Outcome Measures is Time to First Post-operative Negative 24 Hour Fluid Balance; Extracted Interventionsis is Peritoneal dialysis; Conditions is Hypoplastic Left Heart Syndrome ;Sex is ALL ;Age is CHILD

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Pressurised irrigation versus swabbing method in cleansing wounds healed by secondary intention: a randomised controlled trial with cost-effectiveness analysis.Background:Wound cleansing should create an optimal healing environment by removing excess debris, exudates, foreign and necrotic material which are commonly present in the wounds that heal by secondary intention. At present, there is no research evidence for whether pressurised irrigation has better wound healing outcomes compared with conventional swabbing practice in cleansing wound.Objectives:This study investigated the differences between pressurised irrigation and swabbing method in cleansing wounds that healed by secondary intention in relation to wound healing outcomes and cost-effectiveness.Design:Multicentre, prospective, randomised controlled trial.Setting:The study took place in four General Outpatient Clinics in Hong Kong.Methods:Two hundred and fifty six patients with wounds healing by secondary intention were randomly assigned by having a staff independent of the study opening a serially numbered, opaque and sealed envelope to either pressurised irrigation (n=122) or swabbing (n=134). Staff undertaking study-related assessments was blinded to treatment assignment. Patients' wounds were followed up for 6 weeks or earlier if wounds had healed to determine wound healing, infection, symptoms, satisfaction, and cost effectiveness. The primary outcome was time-to-wound healing. Patients were analysed according to their treatment allocation. This trial is registered with ClinicalTrials.gov, number NCT01885273.Results:Intention-to-treat analysis showed that pressurised irrigation group was associated with a shorter median time-to-wound healing than swabbing group [9.0 days (95% CI: 7.4-13.8) vs. 12.0 (95% CI: 10.2-13.8); p=0.007]. Pressurised irrigation group has significantly more patients experiencing lower grade of pain during wound cleansing (93.4% vs. 84.2%; p=0.02), and significantly higher median satisfaction with either comfort or cleansing method (MD 1 [95% CI: 5-6]; p=0.002; MD 1 [95% CI: 5-6]; p<0.001) than did swabbing group. Wound infection was reported in 4 (3.3%) patients in pressurised irrigation group and in 7 (5.2%) patients in swabbing group (p=0.44). Cost-effectiveness analysis indicated that pressurised irrigation in comparison with swabbing saved per patient HK$ 110 (95% CI: -33 to 308) and was a cost-effective cleansing method at no extra direct medical cost with a probability of 90%.Conclusions:This is the first randomised controlled trial to compare the pressurised irrigation and swabbing. Pressurised irrigation is more cost-effective than swabbing in shortening time that wound heals by secondary intention with better patient tolerance. Use of pressurised irrigation for wound cleansing is supported by this trial.

Primary Outcome Measures is time-to-wound healing; Extracted Interventionsis is Pressurized irrigation method Swabbing wound cleansing method; Conditions is Acute and Chronic Wounds ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study.Objective:To identify the effective predictors for therapeutic outcomes based on intermittent theta-burst stimulation (iTBS).Design:A sham-controlled, double-blind parallel study design.Setting:A tertiary hospital.Participants:People with stroke (N=72) who presented with unilateral hemiplegia.Interventions:Ten consecutive sessions of real or sham iTBS were implemented with the aim of enhancing hand function. Patients were categorized into 4 groups according to the presence (MEP+) or absence (MEP-) of motor-evoked potentials (MEPs) and grip strength according to the Medical Research Council (MRC) scale.Main outcome measures:Cortical excitability, Wolf Motor Function Test (WMFT), finger-tapping task (FT), and simple reaction time were performed before and after the sessions.Results:MEPs and the MRC scale were predictive of iTBS therapeutic outcomes. Group A (MEP+, MRC>1) exhibited the greatest WMFT change (7.6±2.3, P<.001), followed by group B (MEP-, MRC>1; 5.2±2.2 score change) and group C (MEP-, MRC=0; 2.3±1.5 score change). These improvements were correlated significantly with baseline motor function and ipsilesional maximum MEP amplitude.Conclusions:The effectiveness of iTBS modulation for poststroke motor enhancement depends on baseline hand grip strength and the presence of MEPs. Our findings indicate that establishing neurostimulation strategies based on the proposed electrophysiological and clinical criteria can allow iTBS to be executed with substantial precision. Effective neuromodulatory strategies can be formulated by using electrophysiological features and clinical presentation information as guidelines.

Primary Outcome Measures is Change of Repeatable Battery for the Assessment of Neuropsychological Status; Extracted Interventionsis is Functional near infrared spectroscopy rTMS; Conditions is Central Nervous System Diseases ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.A Phase 1 randomized study on the safety and pharmacokinetics of OCS-05, a neuroprotective disease modifying treatment for Acute Optic Neuritis and Multiple Sclerosis.OCS-05 (aka BN201) is a peptidomimetic that binds to serum glucocorticoid kinase-2 (SGK2), displaying neuroprotective activity. The objective of this randomized, double-blind 2-part study was to test safety and pharmacokinetics of OCS-05 administered by intravenous (i.v.) infusion in healthy volunteers. Subjects (n = 48) were assigned to receive placebo (n = 12) or OCS-05 (n = 36). , Doses tested were 0.05, 0.2, 0.4, 0.8, 1.6, 2.4 and 3.2 mg/kg in the single ascending dose (SAD) part. In the multiple ascending dose (MAD) part, 2.4 and 3.0 mg/kg doses were administered with 2 h i.v. infusion for 5 consecutive days. Safety assessments included adverse events, blood tests, ECG, Holter monitoring, brain MRI and EEG. No serious adverse events were reported in the OCS-05 group (there was one serious adverse event in the placebo group). Adverse events reported in the MAD part were not clinically significant, and no changes on the ECG, EEG or brain MRI were observed. Single-dose (0.05-3.2 mg/kg) exposure (Cmax and AUC) increased in a dose-proportional manner. Steady state was reached by Day 4 and no accumulation was observed. Elimination half-life ranged from 3.35 to 8.23 h (SAD) and 8.63 to 12.2 h (MAD). Mean individual Cmax concentrations in the MAD part were well below the safety thresholds. OCS-05 administered as 2-h i.v. infusions of multiple doses up to 3.0 mg/Kg daily for up to 5 consecutive days was safe and well tolerated. Based on this safety profile, OCS-05 is currently being tested in a phase 2 trial in patient with acute optic neuritis (NCT04762017, date registration 21/02/2021).

Primary Outcome Measures is Number of patients with treatment-related adverse events (frequencies and percentages tabulated by treatment group); Extracted Interventionsis is OCS-05 IV administration Placebo IV administration; Conditions is Optic Neuritis|Optic; Neuritis, With Demyelination ;Sex is ALL ;Age is ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Women and health professionals' perspectives on a conditional cash transfer programme to improve pregnancy follow-up: a qualitative analysis of the NAITRE randomised controlled study.Objectives:Women of low socioeconomic status have been described as having suboptimal prenatal care, which in turn has been associated with poor pregnancy outcomes. Many types of conditional cash transfer (CCT) programmes have been developed, including programmes to improve prenatal care or smoking cessation during pregnancy, and their effects demonstrated. However, ethical critiques have included paternalism and lack of informed choice. Our objective was to determine if women and healthcare professionals (HPs) shared these concerns.Design:Prospective qualitative research.Setting:We included economically disadvantaged women, as defined by health insurance data, who participated in the French NAITRE randomised trial assessing a CCT programme during prenatal follow-up to improve pregnancy outcomes. The HP worked in some maternities participating in this trial.Participants:26 women, 14 who received CCT and 12 who did not, mostly unemployed (20/26), and - 7 HPs.Interventions:We conducted a multicentre cross-sectional qualitative study among women and HPs who participated in the NAITRE Study to assess their views on CCT. The women were interviewed after childbirth.Results:Women did not perceive CCT negatively. They did not mention feeling stigmatised. They described CCT as a significant source of aid for women with limited financial resources. HP described the CCT in less positive terms, for example, expressing concern about discussing cash transfer at their first medical consultation with women. Though they emphasised ethical concerns about the basis of the trial, they recognised the importance of evaluating CCT.Conclusions:In France, a high-income country where prenatal follow-up is free, HPs were concerned that the CCT programme would change their relationship with patients and wondered if it was the best use of funding. However, women who received a cash incentive said they did not feel stigmatised and indicated that these payments helped them prepare for their baby's birth.Trial registration number:NCT02402855.

Primary Outcome Measures is Occurence of complication(s) of pregnancy; Extracted Interventionsis is Delivery of a prepaid payment card Interview with a sociologist No intervention; Conditions is Pregnancy ;Sex is FEMALE ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Distinct and shared therapeutic neural mechanisms of mindfulness-based and social support stress reduction groups in adults with autism spectrum disorder.Background:Mindfulness-based stress reduction (MBSR) alleviates depression and anxiety in adults with autism spectrum disorder (ASD); however, underlying therapeutic neural mechanisms and mindfulness-specific effects have yet to be elucidated.Methods:We randomly assigned adults with ASD to MBSR or social support/education (SE). They completed questionnaires that assessed depression, anxiety, mindfulness traits, autistic traits and executive functioning abilities as well as a self-reflection functional MRI task. We used repeated-measures analysis of covariance (ANCOVA) to evaluate behavioural changes. To identify task-specific connectivity changes, we performed a generalized psychophysiological interactions (gPPI) functional connectivity (FC) analysis on regions of interest (ROIs; insula, amygdala, cingulum and prefrontal cortex [PFC]). We used Pearson correlations to explore brain-behaviour relationships.Results:Our final sample included 78 adults with ASD - 39 who received MBSR and 39 who received SE. Mindfulness-based stress reduction uniquely improved executive functioning abilities and increased mindfulness traits, whereas both MBSR and SE groups showed reductions in depression, anxiety and autistic traits. Decreases specific to MBSR in insula-thalamus FC were associated with anxiety reduction and increased mindfulness traits, including the trait "nonjudgment;" MBSR-specific decreases in PFC-posterior cingulate connectivity correlated with improved working memory. Both groups showed decreased amygdala-sensorimotor and medial-lateral PFC connectivity, which corresponded with reduced depression.Limitations:Larger sample sizes and neuropsychological evaluations are needed to replicate and extend these findings.Conclusion:Together, our findings suggest that MBSR and SE are similarly efficacious for depression, anxiety and autistic traits, whereas MBSR produced additional salutary effects related to executive functioning and mindfulness traits. Findings from gPPI identified shared and distinct therapeutic neural mechanisms, implicating the default mode and salience networks. Our results mark an early step toward the development of personalized medicine for psychiatric symptoms in ASD and offer novel neural targets for future neurostimulation research.Clinical trial registration:ClinicalTrials.gov identifier NCT04017793.

Primary Outcome Measures is Beck Depression Inventory - II; Extracted Interventionsis is Mindfulness Based Stress Reduction Relaxation Group; Conditions is Autism Spectrum Disorder ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Generalizability of the Results of Efficacy Trials in First-Episode Schizophrenia: Comparing Outcome and Study Discontinuation of Groups of Participants in the Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) Trial.Objective: In the majority of randomized controlled trials (RCTs) conducted in schizophrenia populations, patients suffering from a substance use disorder (SUD) or suicidality are excluded. Excluding these patients from RCTs might impact the generalizability of results. The aim of this study is to determine whether excluding patients with suicidality and/or SUD impacts RCT results on symptomatic remission, premature study discontinuation, symptom severity, and social functioning.Methods: Across Europe and Israel, 481 patients with first-episode schizophrenia, schizophreniform disorder, or schizoaffective disorder, based on DSM-IV criteria, were recruited between May 26, 2011, and May 15, 2016, for the Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) trial. Baseline characteristics and follow-up assessments were compared between patients with versus without baseline SUD and/or suicidality.Results: A total of 446 patients met eligibility criteria for the OPTiMiSE trial and initiated amisulpride treatment, of whom 404 (91%) had data available on suicidality, SUD, duration of illness, and CDS score. Of the 360 eligible patients with baseline data on suicidality and SUD, 106 patients had comorbid suicidality and/or SUD while 254 patients had neither of these comorbidities. No significant differences in the likelihood to achieve symptomatic remission or to prematurely discontinue the study were found when comparing comorbid versus non-comorbid patients (P = .27). There were no significant differences in symptom severity and social functioning between the groups. Comorbid patients had a higher level of depressive symptoms and more impaired social functioning compared to non-comorbid patients.Discussion: Excluding first-episode schizophrenia patients with comorbidities from clinical trials unlikely affects key outcome measures. It is recommended to include patients with comorbidities in clinical trials while carefully monitoring suicidality and implementing safety plans to gain insight into efficacy and safety of treatment in this substantial patient population.Trial Registration: ClinicalTrials.gov identifier: NCT01248195.

Primary Outcome Measures is PANSS; Extracted Interventionsis is Amisulpride open label 6-week amisulpride double blind treatment 6-week olanzapine double blind treatment 12-week clozapine open-label treatment Psychosocial intervention; Conditions is Schizophrenia|Schizophreniform Disorder|Schizoaffective Disorder ;Sex is ALL ;Age is ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Pain prevalence and pain management in children and adolescents in an italian third level pediatric hospital: a cross-sectional study.Background:In 2016, we performed a one-day investigation to analyze the prevalence of pain, pain intensity, and pain therapy in the Departments of Surgery and Onco-Hematology of the Ospedale Pediatrico Bambino Gesù. To improve the knowledge gap highlighted in the previous study, refresher courses and even personalized audits have been carried out during these years. The purpose of this study is to evaluate if, after 5 years, there have been improvements in the management of pain.Methods:The study was conducted on 25 January 2020. Pain assessment, pain therapies, pain prevalence and intensity in the preceding 24 h and during the recovery period were recorded. Pain outcomes were compared with previous audit results.Results:Out of the 63 children with at least one documented pain assessment (starting from 100 eligible), 35 (55.4%) experienced pain: 32 children (50.7%) experienced moderate /severe pain while 3 patients (4%) felt mild pain. In the preceding 24 h, 20 patients (31.7%) reported moderate/severe pain while 10 (16%) reported moderate or severe pain during the interview. The average value of the Pain Management Index (PMI) was - 1.3 ± 0.9 with a minimum of -3 and a maximum of 0. 28 patients (87%) undergoing analgesic therapy for moderate/severe pain had a PMI of less than 0 (undertreated pain), while 3 patients (13%) scored value of 0 or higher (adequate pain therapy), 4 patients (12.5%) received multimodal analgesia with opioids and 2 patients (6%) opioids alone. Time-based therapy was prescribed to 20 patients (62.5%), intermittent therapy was prescribed to 7 patients (22%) and 5 patients (15.5%) did not receive any therapy. The prevalence of pain was higher during hospitalization and 24 h before the interview, while at the time of the interview, the proportion was the same. In this audit, the daily prescription modality of the therapy had some improvements (time-based: 62.5% vs. 44%; intermittent: 22%vs 25%; no therapy: 15.5% vs. 31%).Conclusion:Pain management in hospitalized children constantly requires special daily attention from health professionals aimed at mitigating the components of intractable pain and resolving those of treatable pain.Trial registration:This study is registered with ClinicalTrials.gov, number (NCT04209764), registered 24 December 2019, https://clinicaltrials.gov/ct2/show/NCT04209764?term=NCT04209764&draw=2&rank=1 .

Primary Outcome Measures is Pain in Children: Numbers of patients at the time of interview and twenty four hours before; Extracted Interventionsis is nan; Conditions is Pain, Postoperative|Chronic Pain Syndrome ;Sex is ALL ;Age is CHILD, ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Offering vegetables to children at breakfast time in nursery and kindergarten settings: the Veggie Brek feasibility and acceptability cluster randomised controlled trial.Background:In many Westernised countries, children do not consume a sufficient amount of vegetables for optimal health and development. Child-feeding guidelines have been produced to address this, but often only promote offering vegetables at midday/evening meals and snack times. With guidance having limited success in increasing children's vegetable intake at a population level, novel approaches to address this must be developed. Offering vegetables to children at breakfast time in nursery/kindergarten settings has the potential to increase children's overall daily vegetable consumption as children typically attend nursery/kindergarten and many routinely eat breakfast there. However, the feasibility and acceptability of this intervention (Veggie Brek) to children and nursery staff has not been investigated.Methods:A feasibility and acceptability cluster randomised controlled trial (RCT) was undertaken in eight UK nurseries. All nurseries engaged in one-week baseline and follow-up phases before and after an intervention/control period. Staff in intervention nurseries offered three raw carrot batons and three cucumber sticks alongside children's main breakfast food each day for three weeks. Control nurseries offered children their usual breakfast. Feasibility was assessed by recruitment data and nursery staff's ability to follow the trial protocol. Acceptability was assessed by children's willingness to eat the vegetables at breakfast time. All primary outcomes were assessed against traffic-light progression criteria. Staff preference for collecting data via photographs versus using paper was also assessed. Further views about the intervention were obtained through semi-structured interviews with nursery staff.Results:The recruitment of parents/caregivers willing to provide consent for eligible children was acceptable at 67.8% (within the amber stop-go criterion) with 351 children taking part across eight nurseries. Both the feasibility and acceptability of the intervention to nursery staff and the willingness of children to consume the vegetables met the green stop-go criteria, with children eating some part of the vegetables in 62.4% (745/1194) of instances where vegetables were offered. Additionally, staff preferred reporting data using paper compared to taking photographs.Conclusions:Offering vegetables to children at breakfast time in nursery/kindergarten settings is feasible and acceptable to children and nursery staff. A full intervention evaluation should be explored via a definitive RCT.Trial registration:NCT05217550.

Primary Outcome Measures is Children's willingness to eat vegetables at breakfast as measured by counts of the vegetables eaten; Extracted Interventionsis is Veggie Brek; Conditions is Nutrition, Healthy ;Sex is ALL ;Age is CHILD

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices.Background:It is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity evaluation and examine fidelity moderators of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster-randomized, controlled trial to test the impact of a Community Health Workers (CHW)-led health coaching intervention to prevent incident type 2 Diabetes Mellitus in New York (NY).Methods:We applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descriptive statistics and regression models. PC patients with prediabetes receiving care from safety-net patient-centered medical homes (PCMHs) at either, VA NY Harbor or at Bellevue Hospital (BH) were eligible to be randomized into the CHW-led CHORD intervention or usual care. Among 559 patients randomized and enrolled in the intervention group, 79.4% completed the intake survey and were included in the analytic sample for fidelity assessment. Fidelity was measured as coverage, content adherence and frequency of each core component, and the moderators assessed were implementation site and patient activation measure.Results:Content adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to goal setting (77.4% BH vs. 87.7% VA), educational coaching (78.9% BH vs. 88.3% VA), number of successful CHW-patient encounters (6 BH vs 4 VA) and percent of patients receiving all four components (41.1% BH vs. 25.7% VA).Conclusions:The fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of randomized trials of complex multi-site behavioral interventions.Trial registration:The trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is NCT03006666 .

Primary Outcome Measures is Incidence rates of type 2 DM; Extracted Interventionsis is CHW Training Data Only; Conditions is Diabetes Mellitus ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Time-dependent event accumulation in a cardiovascular outcome trial of patients with type 2 diabetes and established atherosclerotic cardiovascular disease.Background:Estimating cardiovascular (CV) event accrual is important for outcome trial planning. Limited data exist describing event accrual patterns in patients with type 2 diabetes (T2D). We compared apparent CV event accrual patterns with true event rates in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).Methods:Centrally adjudicated event dates and accrual rates for a 4-point major adverse CV event composite (MACE-4; includes CV death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina hospitalization), MACE-4 components, all-cause mortality (ACM), and heart failure hospitalization were compiled. We used three graphical methods (Weibull probability plot, plot of negative log of the Kaplan-Meier survival distribution estimate, and the Epanechnikov kernel-smoothed estimate of the hazard rate) to examine hazard rate morphology over time for the 7 outcomes.Results:Plots for all outcomes showed real-time constant event hazard rates for the duration of the follow-up, confirmed by Weibull shape parameters. The Weibull shape parameters for ACM (1.14, 95% CI 1.08-1.21) and CV death (1.08, 95% CI 1.01-1.16) were not sufficiently > 1 as to require non-constant hazard rate models to accurately depict the data. The time lag between event occurrence and event adjudication being completed, the adjudication gap, improved over the course of the trial.Conclusions:In TECOS, the nonfatal event hazard rates were constant over time. Small increases over time in the hazard rate for fatal events would not require complex modelling to predict event accrual, providing confidence in traditional modelling methods for predicting CV outcome trial event rates in this population. The adjudication gap provides a useful metric to monitor within-trial event accrual patterns.Clinical trial registration:Clinicaltrials.gov NCT00790205.

Primary Outcome Measures is Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population); Extracted Interventionsis is Sitagliptin Placebo; Conditions is Type 2 Diabetes Mellitus ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Comparative efficacy of different combinations of acapella, active cycle of breathing technique, and external diaphragmatic pacing in perioperative patients with lung cancer: a randomised controlled trial.Background:Acapella plus active cycle of breathing technique (ACBT), external diaphragm pacemaker (EDP) plus ACBT have been shown to facilitate the recovery of functional capacity and lung function in patients suffering from airway obstruction but the efficacy in perioperative patients with lung cancer has not been proven.Methods:We conducted a three-arm, prospective, randomized, assessor-blinded, controlled trial in patients with lung cancer who underwent thoracoscopic lobectomy or segmentectomy in the department of thoracic surgery, China. Patients were randomly assigned (1:1:1) to receive Acapella plus ACBT, EDP plus ACBT, or ACBT group (control group) using SAS software. The primary outcome was functional capacity, measured by the 6-minute walk test (6MWT).Results:We recruited 363 participants over 17 months: 123 assigned to the Acapella plus ACBT group, 119 to the EDP plus ACBT group, and 121 to the ACBT group. Statistically significant differences were noted for functional capacity between the EDP plus ACBT and control groups at each follow-up time (1-week follow-up: difference = 47.25 m, 95% CI, 31.56-62.93; P < 0.001; and 1-month follow-up: difference = 49.72 m, 95% CI, 34.04-65.41; P < 0.001), between the Acapella plus ACBT and control groups at postoperative week 1 (difference = 35.23 m, 95% CI, 19.30-51.16; P < 0.001) and postoperative month 1 (difference = 34.96 m, 95% CI, 19.03-50.89; P < 0.001), and between the EDP plus ACBT and Acapella plus ACBT groups at 1-month follow-up (difference = 14.76 m, 95% CI, 1.34-28.19; P = 0.0316).Conclusion:EDP plus ACBT and Acapella plus ACBT significantly improved functional capacity and lung function in perioperative patients with lung cancer, compared with single-model ACBT, and the effects of EDP plus ACBT were clearly superior to those of other programs.Trial registration:The study was registered in the clinical trial database (clinicaltrials.gov) on June 4, 2021 (No. NCT04914624).

Primary Outcome Measures is The change from baseline Forced Expiratory Volume In One Second at one month after surgery; Extracted Interventionsis is ACBT training acpella®PEP EDP-type II external diaphragm pacemaker; Conditions is Rehabilitation ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Effect of butorphanol on visceral pain in patients undergoing gastrointestinal endoscopy: a randomized controlled trial.Background:Butorphanol slightly influences the respiratory and circulatory systems, has a better effect on relieving the discomfort caused by mechanical traction, and has a low incidence of postoperative nausea and vomiting (PONV). Combined butorphanol and propofol may suppress postoperative visceral pain, which is avoidable in gastrointestinal endoscopy. Thus, we hypothesized that butorphanol could decrease the incidence of postoperative visceral pain in patients undergoing gastroscopy and colonoscopy.Methods:This was a randomized, placebo-controlled, and double-blinded trial. Patients undergoing gastrointestinal endoscopy were randomized to intravenously receive either butorphanol (Group I) or normal saline (Group II). The primary outcome was visceral pain after the procedure 10 min after recovery. The secondary outcomes included the rate of safety outcomes and adverse events. Postoperative visceral pain was defined as a visual analog scale (VAS) score ≥ 1.Results:A total of 206 patients were enrolled in the trial. Ultimately, 203 patients were randomly assigned to Group I (n = 102) or Group II (n = 101). In total, 194 patients were included in the analysis: 95 in Group I and 99 in Group II. The incidence of visceral pain at 10 min after recovery was found to be statistically lower with butorphanol than with the placebo (31.5% vs. 68.5%, respectively; RR: 2.738, 95% CI [1.409-5.319], P = 0.002), and the notable difference was in pain level or distribution of visceral pain (P = 0.006).Conclusions:The trial indicated that adding butorphanol to propofol results in a lower incidence of visceral pain after surgery without noticeable fluctuations in circulatory and respiratory functions for gastrointestinal endoscopy patients.Trial registration:Clinicaltrials.gov NCT04477733 (PI: Ruquan Han; date of registration: 20/07/2020).

Primary Outcome Measures is visceral pain; Extracted Interventionsis is Butorphanol Injection Saline; Conditions is Colonoscopy ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Study of efficacy and longevity of immune response to third and fourth doses of COVID-19 vaccines in patients with cancer: A single arm clinical trial.Background:Cancer patients show increased morbidity with COVID-19 and need effective immunization strategies. Many healthcare regulatory agencies recommend administering 'booster' doses of COVID-19 vaccines beyond the standard two-dose series, for this group of patients. Therefore, studying the efficacy of these additional vaccine doses against SARS-CoV-2 and variants of concern is of utmost importance in this immunocompromised patient population.Methods:We conducted a prospective single arm clinical trial enrolling patients with cancer that had received two doses of mRNA or one dose of AD26.CoV2.S vaccine and administered a third dose of mRNA vaccine. We further enrolled patients that had no or low responses to three mRNA COVID vaccines and assessed the efficacy of a fourth dose of mRNA vaccine. Efficacy was assessed by changes in anti-spike antibody, T-cell activity, and neutralization activity, which were again assessed at baseline and 4 weeks.Results:We demonstrate that a third dose of COVID-19 vaccine leads to seroconversion in 57% of patients that were seronegative after primary vaccination series. The immune response is durable as assessed by anti-SARS-CoV-2 (anti-S) antibody titers, T-cell activity, and neutralization activity against wild-type (WT) SARS-CoV2 and BA1.1.529 at 6 months of follow-up. A subset of severely immunocompromised hematologic malignancy patients that were unable to mount an adequate immune response (titer <1000 AU/mL) after the third dose and were treated with a fourth dose in a prospective clinical trial which led to adequate immune boost in 67% of patients. Low baseline IgM levels and CD19 counts were associated with inadequate seroconversion. Booster doses induced limited neutralization activity against the Omicron variant.Conclusions:These results indicate that third dose of COVID vaccine induces durable immunity in cancer patients and an additional dose can further stimulate immunity in a subset of patients with inadequate response.Funding:Leukemia Lymphoma Society, National Cancer Institute.Clinical trial number:NCT05016622.

Primary Outcome Measures is Rates of seroconversion for SARS-CoV-2 spike antibody; Extracted Interventionsis is BNT162b2 vaccine; Conditions is Cancer ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Influence of Culprit Lesion Intervention on Outcomes in Infarct-Related Cardiogenic Shock With Cardiac Arrest.Background:Cardiac arrest (CA) is common in patients with infarct-related cardiogenic shock (CS).Objectives:The goal of this study was to identify the characteristics and outcomes of culprit lesion percutaneous coronary intervention (PCI) of patients with infarct-related CS stratified according to CA in the CULPRIT-SHOCK (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) randomized trial and registry.Methods:Patients with CS with and without CA from the CULPRIT-SHOCK study were analyzed. All-cause death or severe renal failure leading to renal replacement therapy within 30 days and 1-year death were assessed.Results:Among 1,015 patients, 550 (54.2%) had CA. Patients with CA were younger, more frequently male, had lower rates of peripheral artery disease, a glomerular filtration rate <30 mL/min, and left main disease, and they presented more often with clinical signs of impaired organ perfusion. The composite of all-cause death or severe renal failure within 30 days occurred in 51.2% of patients with CA vs 48.5% in non-CA patients (P = 0.39) and 1-year death in 53.8% vs 50.4% (P = 0.29), respectively. In a multivariate analysis, CA was an independent predictor of 1-year mortality (HR: 1.27; 95% CI: 1.01-1.59). In the randomized trial, culprit lesion-only PCI was superior to immediate multivessel PCI in patients both with and without CA (P for interaction = 0.6).Conclusions:More than 50% of patients with infarct-related CS had CA. These patients with CA were younger and had fewer comorbidities, but CA was an independent predictor of 1-year mortality. Culprit lesion-only PCI is the preferred strategy, both in patients with and without CA. (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock [CULPRIT-SHOCK]; NCT01927549).

Primary Outcome Measures is 30-day mortality and/or severe renal failure requiring renal replacement therapy; Extracted Interventionsis is Immediate multivessel PCI Culprit Lesion only PCI; Conditions is Cardiogenic Shock|Acute Myocardial Infarction|Complications ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Final Study Report of Andexanet Alfa for Major Bleeding With Factor Xa Inhibitors.Background:Andexanet alfa is a modified recombinant inactive factor Xa (FXa) designed to reverse FXa inhibitors. ANNEXA-4 (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors) was a multicenter, prospective, phase-3b/4, single-group cohort study that evaluated andexanet alfa in patients with acute major bleeding. The results of the final analyses are presented.Methods:Patients with acute major bleeding within 18 hours of FXa inhibitor administration were enrolled. Co-primary end points were anti-FXa activity change from baseline during andexanet alfa treatment and excellent or good hemostatic efficacy, defined by a scale used in previous reversal studies, at 12 hours. The efficacy population included patients with baseline anti-FXa activity levels above predefined thresholds (≥75 ng/mL for apixaban and rivaroxaban, ≥40 ng/mL for edoxaban, and ≥0.25 IU/mL for enoxaparin; reported in the same units used for calibrators) who were adjudicated as meeting major bleeding criteria (modified International Society on Thrombosis and Haemostasis definition). The safety population included all patients. Major bleeding criteria, hemostatic efficacy, thrombotic events (stratified by occurring before or after restart of either prophylactic [ie, a lower dose, for prevention rather than treatment] or full-dose oral anticoagulation), and deaths were assessed by an independent adjudication committee. Median endogenous thrombin potential at baseline and across the follow-up period was a secondary outcome.Results:There were 479 patients enrolled (mean age, 78 years; 54% male; 86% White); 81% were anticoagulated for atrial fibrillation, and the median time was 11.4 hours since last dose, with 245 (51%) on apixaban, 176 (37%) on rivaroxaban, 36 (8%) on edoxaban, and 22 (5%) on enoxaparin. Bleeding was predominantly intracranial (n=331 [69%]) or gastrointestinal (n=109 [23%]). In evaluable apixaban patients (n=172), median anti-FXa activity decreased from 146.9 ng/mL to 10.0 ng/mL (reduction, 93% [95% CI, 94-93]); in rivaroxaban patients (n=132), it decreased from 214.6 ng/mL to 10.8 ng/mL (94% [95% CI, 95-93]); in edoxaban patients (n=28), it decreased from 121.1 ng/mL to 24.4 ng/mL (71% [95% CI, 82-65); and in enoxaparin patients (n=17), it decreased from 0.48 IU/mL to 0.11 IU/mL (75% [95% CI, 79-67]). Excellent or good hemostasis occurred in 274 of 342 evaluable patients (80% [95% CI, 75-84]). In the safety population, thrombotic events occurred in 50 (10%) patients; in 16 patients, these occurred during treatment with prophylactic anticoagulation that began after the bleeding event. No thrombotic episodes occurred after oral anticoagulation restart. Specific to certain populations, reduction of anti-FXa activity from baseline to nadir significantly predicted hemostatic efficacy in patients with intracranial hemorrhage (area under the receiver operating characteristic curve, 0.62 [95% CI, 0.54-0.70]) and correlated with lower mortality in patients <75 years of age (adjusted P=0.022; unadjusted P=0.003). Median endogenous thrombin potential was within the normal range by the end of andexanet alfa bolus through 24 hours for all FXa inhibitors.Conclusions:In patients with major bleeding associated with the use of FXa inhibitors, treatment with andexanet alfa reduced anti-FXa activity and was associated with good or excellent hemostatic efficacy in 80% of patients.Registration:URL: https://www.Clinicaltrials:gov; Unique identifier: NCT02329327.

Primary Outcome Measures is Percent Change From Baseline In Anti-fXa Activity By FXa Inhibitor; Extracted Interventionsis is Andexanet; Conditions is Bleeding ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Exploring the Relationship Between Efpeglenatide Dose and Cardiovascular Outcomes in Type 2 Diabetes: Insights From the AMPLITUDE-O Trial.Background:In the AMPLITUDE-O (Effect of Efpeglenatide on Cardiovascular Outcomes) cardiovascular outcomes trial, adding either 4 mg or 6 mg weekly of the glucagon-like peptide-1 receptor agonist efpeglenatide to usual care reduced major adverse cardiovascular events (MACE) in people with type 2 diabetes at high cardiovascular risk. Whether these benefits are dose related remains uncertain.Methods:Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide. The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed. A dose-response relationship was assessed using the log-rank test and χ2 statistic for trend.Results:During a median follow-up of 1.8 years, MACE occurred in 125 (9.2%) participants assigned to placebo, 84 (6.2%) participants assigned to 6 mg of efpeglenatide (hazard ratio [HR], 0.65 [95% CI, 0.5-0.86]; P=0.0027), and 105 (7.7%) assigned to 4 mg of efpeglenatide (HR, 0.82 [95% CI, 0.63-1.06]; P=0.14). Participants receiving high-dose efpeglenatide also experienced fewer secondary outcomes, including the composite of MACE, coronary revascularization, or hospitalization for unstable angina (HR, 0.73 for 6 mg, P=0.011; HR, 0.85 for 4 mg, P=0.17), a kidney composite outcome comprising sustained new macroalbuminuria, a ≥40% decline in estimated glomerular filtration rate or renal failure (HR, 0.63 for 6 mg, P<0.0001; HR, 0.73 for 4 mg, P=0.0009), MACE or any death (HR, 0.67 for 6 mg, P=0.0021; HR, 0.81 for 4 mg, P=0.08), a kidney function outcome comprising a sustained ≥40% decline in estimated glomerular filtration rate, renal failure, or death (HR, 0.61 for 6 mg, P=0.0072; HR, 0.97 for 4 mg, P=0.83), and the composite of MACE, any death, heart failure hospitalization, or the kidney function outcome (HR, 0.63 for 6 mg, P=0.0002; HR, 0.81 for 4 mg, P=0.067). A clear dose-response was noted for all primary and secondary outcomes (all P for trend ≤0.018).Conclusions:The graded salutary relationship between efpeglenatide dose and cardiovascular outcomes suggests that titrating efpeglenatide and potentially other glucagon-like peptide-1 receptor agonists to high doses may maximize their cardiovascular and renal benefits.Registration:URL: https://www.Clinicaltrials:gov; Unique identifier: NCT03496298.

Primary Outcome Measures is Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis; Extracted Interventionsis is Efpeglenatide (SAR439977) Placebo; Conditions is Type 2 Diabetes Mellitus ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Effectiveness of antitussives, anticholinergics, and honey versus usual care in adults with uncomplicated acute bronchitis: a multiarm randomized clinical trial.Background:Despite the frequent use of symptomatic therapies in cough, evidence of their benefits is lacking.Objective:We compared the effectiveness of 3 symptomatic therapies and usual care in acute bronchitis.Methods:Multicenter, pragmatic, multiarm parallel group, open randomized trial in primary care (ClinicalTrials.gov, Identifier: NCT03738917) was conducted in Catalonia. Patients ≥18 with uncomplicated acute bronchitis, with cough<3 weeks as the main symptom, scoring ≥4 in either daytime or nocturnal cough (7-point Likert scale), were randomized to usual care, dextromethorphan 15 mg t.i.d., ipratropium bromide inhaler 20 µg 2 puffs t.i.d, or 30 mg of honey t.i.d., all taken for up to 14 days. The main outcome measure was the number of days with moderate-to-severe cough. A symptom diary was given. A second visit was scheduled at days 2-3 for assessing evolution, with 2 more visits at days 15 and 29 for clinical assessment, evaluation of adverse effects, re-attendance, and complications.Results:We failed to achieve the sample size scheduled due to the COVID-19 pandemic. We finally recruited 194 patients. The median number of days with moderate-to-severe cough (score ≥ 3) in the usual care arm was 5 (interquartile range [IQR], 4, 8.75), 5 in the ipratropium bromide arm (IQR, 3, 8), 5 in the dextromethorphan arm (IQR, 4, 9.75), and 6 in the honey arm (IQR, 3.5, 7). The same results were obtained in the Kaplan-Meier survival analysis for the median survival time of each arm with the usual care as the reference group.Conclusion:The symptomatic treatment evaluated has shown to be ineffective against cough.

Primary Outcome Measures is Duration of moderate-severe cough in days in the four arms.; Extracted Interventionsis is Dextromethorphan 15 milligrams Ipratropium Bromide 20Micrograms Inhaler Honey 30 g (full tablespoon) Usual clinical practice; Conditions is Acute Bronchitis ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial.Background:The aim of this study was to investigate safety and immunogenicity of vaccine formulations against respiratory syncytial virus (RSV) containing the stabilized prefusion conformation of RSV fusion protein (RSVPreF3).Methods:This phase 1/2, randomized controlled, observer-blind study enrolled 48 young adults (YAs; aged 18-40 years) and 1005 older adults (OAs; aged 60-80 years) between January and August 2019. Participants were randomized into equally sized groups to receive 2 doses of unadjuvanted (YAs and OAs) or AS01-adjuvanted (OAs) vaccine or placebo 2 months apart. Vaccine safety and immunogenicity were assessed until 1 month (YAs) or 12 months (OAs) after second vaccination.Results:The RSVPreF3 vaccines boosted humoral (RSVPreF3-specific immunoglobulin G [IgG] and RSV-A neutralizing antibody) responses, which increased in an antigen concentration-dependent manner and were highest after dose 1. Compared to prevaccination, the geometric mean frequencies of polyfunctional CD4+ T cells increased after each dose and were significantly higher in adjuvanted than unadjuvanted vaccinees. Postvaccination immune responses persisted until end of follow-up. Solicited adverse events were mostly mild to moderate and transient. Despite a higher observed reactogenicity of AS01-containing vaccines, no safety concerns were identified for any assessed formulation.Conclusions:Based on safety and immunogenicity profiles, the AS01E-adjuvanted vaccine containing 120 μg of RSVPreF3 was selected for further clinical development.Clinical trials registration:NCT03814590.

Primary Outcome Measures is Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose; Extracted Interventionsis is RSV Vaccine (GSK3844766A) unadjuvanted low dose RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B RSV Vaccine (GSK3844766A) unadjuvanted medium dose RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B RSV Vaccine (GSK3844766A) unadjuvanted high dose RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B Placebo (Saline solution); Conditions is Respiratory Syncytial Virus Infections ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Efficacy of combined immunosuppression with or without eltrombopag in children with newly diagnosed aplastic anemia.We compared the efficacy and safety of eltrombopag (ELTR) combined with immunosuppressive therapy (IST) and IST alone in treatment-naïve children with severe (SAA) and very severe (vSAA) aplastic anemia. Ninety-eight pediatric patients were randomized to receive horse antithymocyte globulin (hATG) and cyclosporin A (CsA) with (n = 49) or without (n = 49) ELTR. The primary endpoint was the overall response rate (ORR) at 4 months. After 4 months, nonresponders were crossed over to the alternative group. In all patients, the ORR in ELTR + IST and IST groups was similar (65% vs 53%; P = .218); however, the complete response (CR) rate was significantly higher in the ELTR + IST group (31% vs 12%; P = .027). In severity subgroups, the ORR was 89% vs 57% (P = .028) in favor of IST + ELTR in SAA, but it did not differ in patients with vSAA (52% vs 50%; P = .902). At 6 months after the crossover, 61% of initial ELTR(-) patients achieved a response compared with 17% of initial ELTR(+) patients (P = .016). No significant difference in ELTR + IST and IST groups was observed in the 3-year overall survival (OS) (89% vs 91%; P = .673) or the 3-year event-free survival (EFS) (53% vs 41%; P = .326). There was no unexpected toxicity related to ELTR. Adding ELTR to standard IST was well tolerated and increased the CR rate. The greatest benefit from ELTR combined with IST was observed in patients with SAA but not in those with vSAA. The second course of IST resulted in a high ORR in initial ELTR(-) patients who added ELTR and had limited efficacy among patients who received ELTR upfront. This trial was registered at Clinicaltrials.gov as #NCT03413306.

Primary Outcome Measures is ORR (CR + PR); Extracted Interventionsis is Eltrombopag IST (ATG + CsA); Conditions is Acquired Aplastic Anemia ;Sex is ALL ;Age is CHILD, ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Impact of Computational Modeling on Transcatheter Left Atrial Appendage Closure Efficiency and Outcomes.Background:When performing transcatheter left atrial appendage (LAA) closure, peridevice leaks and device-related thrombus (DRT) have been associated with worse clinical outcomes-hence, their risk should be mitigated.Objectives:The authors sought to assess whether use of preprocedural computational modeling impacts procedural efficiency and outcomes of transcatheter LAA closure.Methods:The PREDICT-LAA trial (NCT04180605) is a prospective, multicenter, randomized trial in which 200 patients were 1:1 randomized to standard planning vs cardiac computed tomography (CT) simulation-based planning of LAA closure with Amplatzer Amulet. The artificial intelligence-enabled CT-based anatomical analyses and computer simulations were provided by FEops (Belgium).Results:All patients had a preprocedural cardiac CT, 197 patients underwent LAA closure, and 181 of these patients had a postprocedural CT scan (standard, n = 91; CT + simulation, n = 90). The composite primary endpoint, defined as contrast leakage distal of the Amulet lobe and/or presence of DRT, was observed in 41.8% in the standard group vs 28.9% in the CT + simulation group (relative risk [RR]: 0.69; 95% CI: 0.46-1.04; P = 0.08). Complete LAA closure with no residual leak and no disc retraction into the LAA was observed in 44.0% vs 61.1%, respectively (RR: 1.44; 95% CI: 1.05-1.98; P = 0.03). In addition, use of computer simulations resulted in improved procedural efficiency with use of fewer Amulet devices (103 vs 118; P < 0.001) and fewer device repositionings (104 vs 195; P < 0.001) in the CT + simulation group.Conclusions:The PREDICT-LAA trial demonstrates the possible added value of artificial intelligence-enabled, CT-based computational modeling when planning for transcatheter LAA closure, leading to improved procedural efficiency and a trend toward better procedural outcomes.

Primary Outcome Measures is Incomplete LAA closure and definite device-related thrombosis (DRT); Extracted Interventionsis is Additional support for preoperative planning of LAA closure procedures Left atrial appendage closure; Conditions is Atrial Fibrillation|Stroke Prevention ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Sexual dysfunction worsens both the general and specific quality of life of women with irritable bowel syndrome. A cross-sectional study.Background:Irritable bowel syndrome (IBS) and sexual dysfunction (SxD) lowers quality of life (QOL) separately, but the effect of their overlap in unselected populations has not been studied.Objective:To evaluate the QOL of IBS women with and without SxD and compare it with controls.Methods:In this cross-sectional assessment, we studied 51 IBS women (Rome IV criteria) and 54 controls. SxD was determined using the female sexual function index questionnaire. QOL was evaluated by the Short Form 36 (SF-36) and IBS-QOL questionnaires.Results:SxD prevalence was similar between IBS women (39.22%) and controls (38.89%). Compared with other groups, IBS patients with SxD showed lower scores in all domains as well as in the physical, mental summaries of the SF-36 and almost all domains (except for body image, food avoidance, and social reaction compared with IBS patients without SxD) and the total score of IBS-QOL.Conclusions:These findings show that SxD worsens both general and specific QOL of women with IBS. The consideration of SxD in patients with IBS will allow us to make a more effective diagnostic and therapeutic approach. Clinical trial registry in Mexico City General Hospital: DI/19/107/03/080.Clinical trials registration:NCT04716738.

Primary Outcome Measures is Change on barostat study during menstrual cycle; Extracted Interventionsis is Blood analyses and coprological; Conditions is Irritable Bowel Syndrome|Sexual Dysfunction ;Sex is FEMALE ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Electroacupuncture for the management of symptom clusters in cancer patients and survivors (EAST).Background:Neuropsychiatric symptoms, comprising cognitive impairment, fatigue, insomnia, depression, and anxiety, are prevalent and may co-occur during and after chemotherapy treatment for cancer. Electroacupuncture (EA), which involves mild electrical stimulation with acupuncture, holds great potential in addressing the management of individual symptoms. However, there is a lack of studies evaluating if EA can manage concurrent neuropsychiatric symptoms in cancer (i.e., symptom cluster). Hence, we designed a trial to evaluate the efficacy, safety, and feasibility of administering EA as an intervention to mitigate neuropsychiatric symptom clusters amongst cancer patients and survivors.Methods:The EAST study is a randomized, sham-controlled, patient- and assessor-blinded clinical trial. Sixty-four cancer patients and survivors with complaints of one or more neuropsychiatric symptom(s) in the seven days prior to enrollment are recruited from the University of California Irvine (UCI) and Children's Hospital of Orange County (CHOC). Individuals with needle phobia, metastases, bleeding disorders, electronic implants, epilepsy, exposure to acupuncture in the three months prior to enrollment, and who are breastfeeding, pregnant, or planning to get pregnant during the duration of the study will be excluded. Screening for metal fragments and claustrophobia are performed prior to the optional neuroimaging procedures. Recruited patients will be randomized (1:1) in random blocks of four or six to receive either ten weekly verum EA (treatment arm, vEA) or weekly sham EA (control arm, sEA) treatment visits with a follow-up appointment four to twelve weeks after their last treatment visit. The treatment arm will receive EA at 13 acupuncture points (acupoints) chosen for their therapeutic effects, while the control arm receives minimal EA at 7 non-disease-related acupoints. Questionnaires and cognitive assessments are administered, and blood drawn to assess changes in symptom clusters and biomarkers, respectively.Conclusion:The EAST study can provide insight into the efficacy of EA, an integrative medicine modality, in the management of cancer symptom clusters in routine clinical practice.Trial registration:This trial is registered with clinicaltrials.gov NCT05283577.

Primary Outcome Measures is Subjective Cognitive Function (FACT-Cog version 3); Extracted Interventionsis is Electroacupuncture Sham-Electroacupuncture; Conditions is Cancer ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Evidence of a cognitive bias in the quantification of COVID-19 with CT: an artificial intelligence randomised clinical trial.Chest computed tomography (CT) has played a valuable, distinct role in the screening, diagnosis, and follow-up of COVID-19 patients. The quantification of COVID-19 pneumonia on CT has proven to be an important predictor of the treatment course and outcome of the patient although it remains heavily reliant on the radiologist's subjective perceptions. Here, we show that with the adoption of CT for COVID-19 management, a new type of psychophysical bias has emerged in radiology. A preliminary survey of 40 radiologists and a retrospective analysis of CT data from 109 patients from two hospitals revealed that radiologists overestimated the percentage of lung involvement by 10.23 ± 4.65% and 15.8 ± 6.6%, respectively. In the subsequent randomised controlled trial, artificial intelligence (AI) decision support reduced the absolute overestimation error (P < 0.001) from 9.5% ± 6.6 (No-AI analysis arm, n = 38) to 1.0% ± 5.2 (AI analysis arm, n = 38). These results indicate a human perception bias in radiology that has clinically meaningful effects on the quantitative analysis of COVID-19 on CT. The objectivity of AI was shown to be a valuable complement in mitigating the radiologist's subjectivity, reducing the overestimation tenfold.Trial registration: https://Clinicaltrial.gov . Identifier: NCT05282056, Date of registration: 01/02/2022.

Primary Outcome Measures is Mean difference of lung affection quantification percentage; Extracted Interventionsis is CAD analysis; Conditions is COVID-19 ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.12-Month clinical and radiographic outcomes of ViBone viable bone matrix in patients undergoing cervical and lumbar spinal fusion surgery.Background:To investigate the clinical safety and efficacy of ViBone® Viable Bone Matrix (VBM), a next generation cellular bone matrix allograft that comprises all three essential bone-forming components: osteogenic, osteoinductive, and osteoconductive factors, and is optimized to enhance cell viability and bone formation.Methods:This was a multi-center, prospective, post-market study evaluating the safety and efficacy of ViBone VBM in patients undergoing 1-3 level anterior cervical discectomy and fusion or lumbar interbody fusion surgery. Patients were evaluated at baseline, 6-month, and 12-month follow-up clinically and radiographically. Clinical assessment included Visual Analog Scale for pain (VAS-pain), the Neck Disability Index (NDI) for patients with cervical pathologies, and the Oswestry Disability Index (ODI) for patients with lumbar pathologies. Fusion success defined by an independent radiologist was determined radiographically by plain films.Results:Clinical outcomes evaluated with VAS-pain, NDI, and ODI scales were improved significantly at 6 and 12 months compared to baseline. All patients reached clinically significant improvements at 12 months. There were no adverse events or infections attributed to ViBone VBM. At 12 months, the fusion rate per patient was 88.1% in cervical and 97.6% in lumbar patients, while per-level fusion was 98.5% for cervical and 100% for lumbar segments.Conclusions:Patients undergoing cervical and lumbar spinal fusion implanted with ViBone VBM demonstrated favorable outcomes at 6 months and 12 months as measured by subjective clinical measures and radiographic fusion rates. Trial registration This study was registered as NCT03425682 on 1/29/2018.

Primary Outcome Measures is Fusion; Extracted Interventionsis is ViBone; Conditions is Spondylosis|Cervical Spondylosis|Spondylolisthesis|Herniated Nucleus Pulposus|Degenerative Disc Disease ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases.Background:Stereotactic radiosurgery (SRS) is a frequently chosen treatment for patients with brain metastases and the number of long-term survivors is increasing. Brain necrosis (e.g. radionecrosis) is the most important long-term side effect of the treatment. Retrospective studies show a lower risk of radionecrosis and local tumor recurrence after fractionated stereotactic radiosurgery (fSRS, e.g. five fractions) compared with stereotactic radiosurgery in one or three fractions. This is especially true for patients with large brain metastases. As such, the 2022 ASTRO guideline of radiotherapy for brain metastases recommends more research to fSRS to reduce the risk of radionecrosis. This multicenter prospective randomized study aims to determine whether the incidence of adverse local events (either local failure or radionecrosis) can be reduced using fSRS versus SRS in one or three fractions in patients with brain metastases.Methods:Patients are eligible with one or more brain metastases from a solid primary tumor, age of 18 years or older, and a Karnofsky Performance Status ≥ 70. Exclusion criteria include patients with small cell lung cancer, germinoma or lymphoma, leptomeningeal metastases, a contraindication for MRI, prior inclusion in this study, prior surgery for brain metastases, prior radiotherapy for the same brain metastases (in-field re-irradiation). Participants will be randomized between SRS with a dose of 15-24 Gy in 1 or 3 fractions (standard arm) or fSRS 35 Gy in five fractions (experimental arm). The primary endpoint is the incidence of a local adverse event (local tumor failure or radionecrosis identified on MRI scans) at two years after treatment. Secondary endpoints are salvage treatment and the use of corticosteroids, bevacizumab, or antiepileptic drugs, survival, distant brain recurrences, toxicity, and quality of life.Discussion:Currently, limiting the risk of adverse events such as radionecrosis is a major challenge in the treatment of brain metastases. fSRS potentially reduces this risk of radionecrosis and local tumor failure.Trial registration:ClincalTrials.gov, trial registration number: NCT05346367 , trial registration date: 26 April 2022.

Primary Outcome Measures is radio necrosis or local failure; Extracted Interventionsis is SRT fSRT; Conditions is Brain Metastases ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Effect of monthly intermittent preventive treatment with dihydroartemisinin-piperaquine with and without azithromycin versus monthly sulfadoxine-pyrimethamine on adverse pregnancy outcomes in Africa: a double-blind randomised, partly placebo-controlled trial.Background:Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine is more effective than IPTp with sulfadoxine-pyrimethamine at reducing malaria infection during pregnancy in areas with high-grade resistance to sulfadoxine-pyrimethamine by Plasmodium falciparum in east Africa. We aimed to assess whether IPTp with dihydroartemisinin-piperaquine, alone or combined with azithromycin, can reduce adverse pregnancy outcomes compared with IPTp with sulfadoxine-pyrimethamine.Methods:We did an individually randomised, double-blind, three-arm, partly placebo-controlled trial in areas of high sulfadoxine-pyrimethamine resistance in Kenya, Malawi, and Tanzania. HIV-negative women with a viable singleton pregnancy were randomly assigned (1:1:1) by computer-generated block randomisation, stratified by site and gravidity, to receive monthly IPTp with sulfadoxine-pyrimethamine (500 mg of sulfadoxine and 25 mg of pyrimethamine for 1 day), monthly IPTp with dihydroartemisinin-piperaquine (dosed by weight; three to five tablets containing 40 mg of dihydroartemisinin and 320 mg of piperaquine once daily for 3 consecutive days) plus a single treatment course of placebo, or monthly IPTp with dihydroartemisinin-piperaquine plus a single treatment course of azithromycin (two tablets containing 500 mg once daily for 2 consecutive days). Outcome assessors in the delivery units were masked to treatment group. The composite primary endpoint was adverse pregnancy outcome, defined as fetal loss, adverse newborn baby outcomes (small for gestational age, low birthweight, or preterm), or neonatal death. The primary analysis was by modified intention to treat, consisting of all randomised participants with primary endpoint data. Women who received at least one dose of study drug were included in the safety analyses. This trial is registered with ClinicalTrials.gov, NCT03208179.Findings:From March-29, 2018, to July 5, 2019, 4680 women (mean age 25·0 years [SD 6·0]) were enrolled and randomly assigned: 1561 (33%; mean age 24·9 years [SD 6·1]) to the sulfadoxine-pyrimethamine group, 1561 (33%; mean age 25·1 years [6·1]) to the dihydroartemisinin-piperaquine group, and 1558 (33%; mean age 24·9 years [6.0]) to the dihydroartemisinin-piperaquine plus azithromycin group. Compared with 335 (23·3%) of 1435 women in the sulfadoxine-pyrimethamine group, the primary composite endpoint of adverse pregnancy outcomes was reported more frequently in the dihydroartemisinin-piperaquine group (403 [27·9%] of 1442; risk ratio 1·20, 95% CI 1·06-1·36; p=0·0040) and in the dihydroartemisinin-piperaquine plus azithromycin group (396 [27·6%] of 1433; 1·16, 1·03-1·32; p=0·017). The incidence of serious adverse events was similar in mothers (sulfadoxine-pyrimethamine group 17·7 per 100 person-years, dihydroartemisinin-piperaquine group 14·8 per 100 person-years, and dihydroartemisinin-piperaquine plus azithromycin group 16·9 per 100 person-years) and infants (sulfadoxine-pyrimethamine group 49·2 per 100 person-years, dihydroartemisinin-piperaquine group 42·4 per 100 person-years, and dihydroartemisinin-piperaquine plus azithromycin group 47·8 per 100 person-years) across treatment groups. 12 (0·2%) of 6685 sulfadoxine-pyrimethamine, 19 (0·3%) of 7014 dihydroartemisinin-piperaquine, and 23 (0·3%) of 6849 dihydroartemisinin-piperaquine plus azithromycin treatment courses were vomited within 30 min.Interpretation:Monthly IPTp with dihydroartemisinin-piperaquine did not improve pregnancy outcomes, and the addition of a single course of azithromycin did not enhance the effect of monthly IPTp with dihydroartemisinin-piperaquine. Trials that combine sulfadoxine-pyrimethamine and dihydroartemisinin-piperaquine for IPTp should be considered.Funding:European & Developing Countries Clinical Trials Partnership 2, supported by the EU, and the UK Joint-Global-Health-Trials-Scheme of the Foreign, Commonwealth and Development Office, Medical Research Council, Department of Health and Social Care, Wellcome, and the Bill-&-Melinda-Gates-Foundation.

Primary Outcome Measures is Adverse pregnancy outcome; Extracted Interventionsis is dihydroartemisinin-piperaquine sulphadoxine-pyrimethamine dihydroartemisinin-piperaquine plus azithromycin; Conditions is Pregnancy|Malaria in Pregnancy|Malaria ;Sex is FEMALE ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II).Background:Baricitinib is an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. In a 24-week phase 2 study in patients with systemic lupus erythematosus (SLE), baricitinib 4 mg significantly improved SLE disease activity compared with placebo. In this Article, we report the evaluation of efficacy and safety of baricitinib in patients with SLE in a 52-week phase 3 study.Methods:In this phase 3 double-blind, randomised, placebo-controlled study, SLE-BRAVE-II, patients (aged ≥18 years) with active SLE receiving stable background therapy were randomly assigned 1:1:1 to baricitinib 4 mg, baricitinib 2 mg, or placebo once daily for 52 weeks. The primary endpoint was the proportion of patients with an SLE Responder Index (SRI)-4 response at week 52 in the baricitinib 4 mg treatment group compared with placebo. Glucocorticoid tapering was encouraged but not required per protocol. The primary endpoint was assessed by logistic regression analysis with baseline disease activity, baseline corticosteroid dose, region, and treatment group in the model. Efficacy analyses were done on an intention-to-treat population, comprising all participants who were randomly assigned and received at least one dose of investigational product and who did not discontinue from the study for the reason of lost to follow-up at the first post-baseline visit. Safety analyses were done on all randomly assigned participants who received at least one dose of investigational product and who did not discontinue. This study is registered with ClinicalTrials.gov, NCT03616964, and is complete.Findings:A total of 775 patients were randomly assigned and received at least one dose of baricitinib 4 mg (n=258), baricitinib 2 mg (n=261), or placebo (n=256). There was no difference in the primary efficacy outcome of the proportion of SRI-4 responders at week 52 between participants who received baricitinib 4mg (121 [47%]; odds ratio 1·07 [95% CI 0·75 to 1·53]; difference with placebo 1·5 [95% CI -7·1 to 10·2]), 2 mg (120 [46%]; 1·05 [0·73 to 1·50]; 0·8 [-7·9 to 9·4]) and placebo (116 [46%]). None of the major secondary endpoints, including glucocorticoid tapering and time to first severe flare, were met. Serious adverse events were observed in 29 (11%) participants in the baricitinib 4 mg group, 35 (13%) in the baricitinib 2 mg group, and 22 (9%) in the placebo group. The safety profile of baricitinib in patients with SLE was consistent with the known baricitinib safety profile.Interpretation:Although phase 2 data suggested baricitinib as a potential treatment for patients with SLE, which was supported in SLE-BRAVE-I, this result was not replicated in SLE-BRAVE-II. No new safety signals were observed.Funding:Eli Lilly and Company.

Primary Outcome Measures is Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib); Extracted Interventionsis is Baricitinib Placebo; Conditions is Systemic Lupus Erythematosus ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I).Background:Baricitinib is an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. In a 24-week phase 2 study in patients with systemic lupus erythematosus (SLE), baricitinib 4 mg significantly improved SLE disease activity compared with placebo. The objective of this trial was to evaluate the efficacy and safety of baricitinib in patients with active SLE in a 52-week phase 3 study.Methods:In a multicentre, double-blind, randomised, placebo-controlled, parallel-group, phase 3 study, SLE-BRAVE-I, patients (aged ≥18 years) with active SLE receiving stable background therapy were randomly assigned 1:1:1 to baricitinib 4 mg, 2 mg, or placebo once daily for 52 weeks with standard of care. Glucocorticoid tapering was encouraged but not required per protocol. The primary endpoint was the proportion of patients reaching an SLE Responder Index (SRI)-4 response at week 52 in the baricitinib 4 mg treatment group compared with placebo. The primary endpoint was assessed by logistic regression analysis with baseline disease activity, baseline corticosteroid dose, region, and treatment group in the model. Efficacy analyses were done on a modified intention-to-treat population, comprising all participants who were randomly assigned and received at least one dose of investigational product. Safety analyses were done on all randomly assigned participants who received at least one dose of investigational product and who did not discontinue from the study for the reason of lost to follow-up at the first post-baseline visit. This study is registered with ClinicalTrials.gov, NCT03616912.Findings:760 participants were randomly assigned and received at least one dose of baricitinib 4 mg (n=252), baricitinib 2 mg (n=255), or placebo (n=253). A significantly greater proportion of participants who received baricitinib 4 mg (142 [57%]; odds ratio 1·57 [95% CI 1·09 to 2·27]; difference with placebo 10·8 [2·0 to 19·6]; p=0·016), but not baricitinib 2 mg (126 [50%]; 1·14 [0·79 to 1·65]; 3·9 [-4·9 to 12·6]; p=0·47), reached SRI-4 response compared with placebo (116 [46%]). There were no significant differences between the proportions of participants in either baricitinib group reaching any of the major secondary endpoints compared with placebo, including glucocorticoid tapering and time to first severe flare. 26 (10%) participants receiving baricitinib 4 mg had serious adverse events, 24 (9%) participants receiving baricitinib 2 mg, and 18 (7%) participants receiving placebo. The safety profile of baricitinib in participants with SLE was consistent with the known baricitinib safety profile.Interpretation:The primary endpoint in this study was met for the 4 mg baricitinib group. However, key secondary endpoints were not. No new safety signals were observed.Funding:Eli Lilly and Company.

Primary Outcome Measures is Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib); Extracted Interventionsis is Baricitinib Placebo; Conditions is Systemic Lupus Erythematosus ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Effect of group education and person-centered support in primary health care on mental health and quality of life in women aged 45-60 years with symptoms commonly associated with stress: a randomized controlled trial.Background:Mental illness and somatic symptoms are common causes of long-term sick leave for women during menopause, which usually occurs between the ages of 45 and 55. Many women experience a lack of knowledge about menopause and its associated symptoms. This study evaluates the effect of group education and person-centered individual support in primary health care (PHC) on mental health and quality of life for women in menopause with symptoms that are usually associated with stress.Methods:The randomized controlled clinical trial (RCT) with a two-factor design was conducted in PHC in southwestern Sweden, from 2018 to 2019. A total of 370 women aged 45-60 were allocated in four groups: 1, group education (GE) 2, GE and person-centered individual support (PCS) 3, PCS and 4, control group. GE comprised four weekly sessions and PCS included five sessions with topics related to menopause. The effect of the interventions were followed up at 6 and 12 months. Linear and ordinal regression were used to analyse the effect of the intervention, either group education or person-centred individual support.Results:The main findings: Improved quality of life and physical, psychological, and urogenital symptoms. GE and PCS resulted in improvement of the quality of life at six months. At the 12-month follow-up these results were significantly strengthened for PCS and improved health-related quality of life, and reduced mental, urogenital, and stress-related symptoms with an effect lasting at least 12 months. These results suggest that this intervention could be an effective intervention in PHC for improving women's health in menopause.Conclusions:PCS can be an effective intervention in PHC for improving women's health in menopause and possibly also prevent the development of exhaustion syndrome.Trial registration:Universal trial number is U1111-1219-6542 and the registration number in ClinicalTrials.gov is NCT03663075, date of registration 10/09/2018.

Primary Outcome Measures is Short term effect of group education (GI) on change in quality of life; Extracted Interventionsis is Group information (GI) Structured person-centered support (PCS); Conditions is Women's Health|Quality of Life|Mental Health|Menopause|Primary Health Care|Sick Leave ;Sex is FEMALE ;Age is ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.MEDEA randomised intervention study protocol in Cyprus, Greece and Israel for mitigation of desert dust health effects in adults with atrial fibrillation.Introduction:Mediterranean countries experience frequent desert dust storm (DDS) events originating from neighbouring Sahara and Arabian deserts, which are associated with significant increase in mortality and hospital admissions, mostly from cardiovascular and respiratory diseases. Short-term exposure to ambient air pollution is considered as a trigger for symptomatic exacerbations of pre-existing paroxysmal atrial fibrillation (AF) and other types of heart arrhythmia. The Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches clinical randomised intervention study in adults with AF is funded by EU LIFE+programme to evaluate the efficacy of recommendations aiming to reduce exposure to desert dust and related heart arrhythmia effects.Methods and analysis:The study is performed in three heavily exposed to desert dust regions of the Eastern Mediterranean: Cyprus, Israel and Crete-Greece. Adults with paroxysmal AF and implanted pacemaker are recruited and randomised to three parallel groups: (a) no intervention, (b) interventions to reduce outdoor exposure to desert dust, (c) interventions to reduce both outdoor and indoor exposure to particulate matter during desert dust episodes. Eligible participants are enrolled on a web-based platform which communicates, alerts and makes exposure reduction recommendations during DDS events. Exposure changes are assessed by novel tools (smartwatches with Global Positioning System and physical activity sensors, air pollution samplers assessing air quality inside and outside participant's homes, etc). Clinical outcomes include the AF burden expressed as the percentage of time with paroxysmal AF over the total study period, the incidence of ventricular arrhythmia episodes as recorded by the participants' pacemakers or cardioverters/defibrillators and the disease-specific Atrial Fibrillation Effect on QualiTy-of-Life questionnaire.Ethics and dissemination:Local bioethics' authorities approved the study at all sites, according to national legislations (Cyprus: National Bioethics Committee, Data Protection Commissioner and Ministry of Health; Greece, Scientific Committee and Governing Board of the University General Hospital of Heraklion; Israel: Institutional Review Board ('Helsinki committee') of the Soroka University Medical Center). The findings will be publicised in peer-reviewed scientific journals, in international conferences and in professional websites and newsletters. A summary of the results and participants' interviews will be included in a documentary in English, Greek and Hebrew.Trial registration number:ClinicalTrials.gov Identifier; NCT03503812.

Primary Outcome Measures is Comparison of Asthma Control Test (ACT) questionnaire score between the no intervention group and the intervention groups in asthmatic children during the high DDS period of 2019; Extracted Interventionsis is Intervention (1) for outdoor exposure reduction - Asthma in Children Intervention (2) for outdoor and indoor exposure reduction - Asthma in Children Intervention (1) for outdoor exposure reduction - Atrial Fibrillation Intervention (2) for outdoor and indoor exposure reduction - Atrial Fibrillation; Conditions is Asthma in Children|Atrial Fibrillation ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Six-month safety follow-up of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in adults: A phase 2/3, double-blind, randomized study.Background:We evaluated the safety of SCB-2019, a protein subunit vaccine candidate containing a recombinant SARS-CoV-2 spike (S) trimer fusion protein, combined with CpG-1018/alum adjuvants.Methods:This ongoing phase 2/3, double-blind, placebo-controlled, randomized trial is being conducted in Belgium, Brazil, Colombia, the Philippines, and South Africa in participants ≥ 12 years of age. Participants were randomly assigned to receive 2 doses of SCB-2019 or placebo administered intramuscularly 21 days apart. Here, we present the safety results of SCB-2019 over the 6-month period following 2-dose primary vaccination series in all adult participants (≥18 years of age).Results:A total of 30,137 adult participants received at least one dose of study vaccine (n = 15,070) or placebo (n = 15,067) between 24 March 2021 and 01 December 2021. Unsolicited adverse events, medically-attended adverse events, adverse events of special interest, and serious adverse events were reported in similar frequencies in both study arms over the 6-month follow-up period. Vaccine-related SAEs were reported by 4 of 15,070 SCB-2019 recipients (hypersensitivity reactions in two participants, Bell's palsy, and spontaneous abortion) and 2 of 15,067 placebo recipients (COVID-19, pneumonia, and acute respiratory distress syndrome in one participant and spontaneous abortion in the other one). No signs of vaccine-associated enhanced disease were observed.Conclusions:SCB-2019 administered as a 2-dose series has an acceptable safety profile. No safety concerns were identified during the 6-month follow-up after the primary vaccination.Clinical trials registration:NCT04672395; EudraCT: 2020-004272-17.

Primary Outcome Measures is Number of Participants with a First Occurrence of COVID-19 of Any Severity Starting 14 Days after Second Dose of SCB-2019; Extracted Interventionsis is CpG 1018/Alum-adjuvanted SCB-2019 vaccine Placebo; 0.9% saline SCB-2019 vaccine SCB-2019 vaccine for Placebo; Conditions is COVID-19 ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.A randomized phase I/II safety and immunogenicity study of the Montanide-adjuvanted SARS-CoV-2 spike protein-RBD-Fc vaccine, AKS-452.Background:Previous interim data from a phase I study of AKS-452, a subunit vaccine comprising an Fc fusion of the respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein receptor binding domain (SP/RBD) emulsified in the water-in-oil adjuvant, Montanide™ ISA 720, suggested a good safety and immunogenicity profile in healthy adults. This phase I study was completed and two dosing regimens were further evaluated in this phase II study.Methods:This phase II randomized, open-labelled, parallel group study was conducted at a single site in The Netherlands with 52 healthy adults (18 - 72 years) receiving AKS-452 subcutaneously at one 90 µg dose (cohort 1, 26 subjects) or two 45 µg doses 28 days apart (cohort 2, 26 subjects). Serum samples were collected at the first dose (day 0) and at days 28, 56, 90, and 180. Safety and immunogenicity endpoints were assessed, along with induction of IgG isotypes, cross-reactive immunity against viral variants, and IFN-γ T cell responses.Results:All AEs were mild/moderate (grades 1 or 2), and no SAEs were attributable to AKS-452. Seroconversion rates reached 100% in both cohorts, although cohort 2 showed greater geometric mean IgG titers that were stable through day 180 and associated with enhanced potencies of SP/RBD-ACE2 binding inhibition and live virus neutralization. AKS-452-induced IgG titers strongly bound mutant SP/RBD from several SARS-CoV-2 variants (including Omicrons) that were predominantly of the favorable IgG1/3 isotype and IFN-γ-producing T cell phenotype.Conclusion:These favorable safety and immunogenicity profiles of the candidate vaccine as demonstrated in this phase II study are consistent with those of the phase I study (ClinicalTrials.gov: NCT04681092) and suggest that a total of 90 µg received in 2 doses may offer a greater duration of cross-reactive neutralizing titers than when given in a single dose.

Primary Outcome Measures is Safety / Tolerability; Extracted Interventionsis is AKS-452; Conditions is Covid19 ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine coadministered with quadrivalent influenza vaccine: A phase 3 randomized trial.Introduction:Older adults are at increased risk of adverse outcomes from pneumococcal disease and influenza infections. Vaccination is an established strategy for preventing both illnesses. This study evaluated coadministration of 20-valent pneumococcal conjugate vaccine (PCV20) and an adjuvanted quadrivalent inactivated influenza vaccine (QIV).Methods:This phase 3, randomized, double-blind, multicenter study included 1796 US adults ≥ 65 years of age randomized 1:1 to receive either PCV20 and QIV followed 1 month later by saline (Coadministration group) or QIV and saline followed 1 month later by PCV20 (Separate Administration group). Primary immunogenicity objectives were to show noninferiority of PCV20 and QIV coadministration compared with separate administration of either vaccine based on serotype-specific opsonophagocytic activity (OPA) titers for PCV20 and strain-specific hemagglutination inhibition assay (HAI) titers for QIV. Safety endpoints included local reactions, systemic events, and adverse events (AEs).Results:Noninferiority for pneumococcal and influenza antibody responses (lower bound 95 % CI of the OPA and HAI geometric mean ratios of > 0.5 and > 0.67, respectively) was shown for the Coadministration group compared with the Separate Administration group for all 20 pneumococcal serotypes and all 4 influenza vaccine strains. Local reactions and systemic events were mostly mild or moderate in severity across groups; injection site pain was the most frequent local reaction, and fatigue was the most frequent systemic event. Mild and moderate fatigue were reported more frequently after PCV20 and QIV coadministration compared with separate administration (mild, 20.0 % vs 10.8 %-12.6 %; moderate, 12.3 % vs 8.4 %-9.6 %); this was not considered clinically significant. AE reporting rates were similar across groups, and no serious AEs were considered vaccination-related.Conclusions:Immune responses after coadministration of PCV20 and QIV were noninferior to separate administration of either vaccine. The PCV20 safety profile was similar when given together with or after QIV. These findings support PCV20 and QIV coadministration.Trial registration:ClinicalTrials.gov, NCT04526574.

Primary Outcome Measures is Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC; Extracted Interventionsis is Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) Saline Influenza vaccine; Conditions is Pneumococcal Disease ;Sex is ALL ;Age is OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Active school transport in an urban environment:prevalence and perceived barriers.Background:Active school transport (AST) can increase children's and adolescents' physical activity. The proportion of children and adolescents who engage in AST has declined internationally in recent decades. This study examines the prevalence, correlates, and perceived barriers to AST in the city of Leipzig, Germany.Methods:The study sample includes 1070 participants, 364 children and 706 adolescents, aged between 6 and 18 years, as well as their parents. The parents as well as adolescents age 10 and above completed questionnaires concerning sociodemographic variables, means of transport/AST and perceived barriers to AST. The distance between home and school was calculated as the network distance from the home to school address using the Dijkstra algorithm. Based on these data, logistic models were fitted in a two-step variable selection process, using AST as the dependent variable.Results:Approximately half of the children (59%) and adolescents (51%) engaged in AST. The prevalence of AST exhibited a negative correlation with age (Odds Ratio (OR) = 0.94, 95% confidence interval (CI) = 0.9-0.99, p = 0.015) and did not significantly differ by gender (children: ORgirls = 1.5, CI = 0.95-2.25, p = 0.075, adolescents: ORgirls = 1.01, CI = 0.75-1.37, p = 0.924). A high socioeconomic status was positively correlated to AST on the morning trip (OR = 1.7, CI 1.3-2.21, p < 0.01) but negatively on the afternoon trip (OR = 0.7, CI = 0.53-0.9, p < 0.01) in the summer. Common barriers for children (from their parents' perspective) and for adolescents (from their own and their parents' perspective) were distance and a heavy load to carry. The parents of adolescents did not perceive any other specific barriers as a serious impediment. Further significant barriers perceived by the younger children's parents were adults giving a lift on the way to other errands, no other children to walk or cycle with, and too much traffic. Too much traffic was also a significant barrier for adolescents, as were taking too much time and bad weather conditions.Conclusions:Future interventions promoting AST in an urban environment should be guided by the identified perceived barriers.Trial registration:LIFE Child has been retrospectively registered with ClinicalTrials.gov (NCT02550236).

Primary Outcome Measures is Civilization diseases and their risk factors; Extracted Interventionsis is nan; Conditions is Child Development ;Sex is ALL ;Age is CHILD, ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Tolerability of concurrent external beam radiotherapy and [177Lu]Lu-PSMA-617 for node-positive prostate cancer in treatment naïve patients, phase I study (PROQURE-I trial).Background:Prostate cancer patients with locoregional lymph node disease at diagnosis (N1M0) still have a limited prognosis despite the improvements provided by aggressive curative intent multimodal locoregional external beam radiation therapy (EBRT) with systemic androgen deprivation therapy (ADT). Although some patients can be cured and the majority of patients have a long survival, the 5-year biochemical failure rate is currently 29-47%. [177Lu]Lu-PSMA-617 has shown impressive clinical and biochemical responses with low toxicity in salvage setting in metastatic castration-resistant prostate cancer. This study aims to explore the combination of standard EBRT and ADT complemented with a single administration of [177Lu]Lu-PSMA-617 in curative intent treatment for N1M0 prostate cancer. Hypothetically, this combined approach will enhance EBRT to better control macroscopic tumour localizations, and treat undetected microscopic disease locations inside and outside EBRT fields.Methods:The PROQURE-I study is a multicenter prospective phase I study investigating standard of care treatment (7 weeks EBRT and 3 years ADT) complemented with one concurrent cycle (three, six, or nine GBq) of systemic [177Lu]Lu-PSMA-617 administered in week two of EBRT. A maximum of 18 patients with PSMA-positive N1M0 prostate cancer will be included. The tolerability of adding [177Lu]Lu-PSMA-617 will be evaluated using a Bayesian Optimal Interval (BOIN) dose-escalation design. The primary objective is to determine the maximum tolerated dose (MTD) of a single cycle [177Lu]Lu-PSMA-617 when given concurrent with EBRT + ADT, defined as the occurrence of Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 grade three or higher acute toxicity. Secondary objectives include: late toxicity at 6 months, dosimetric assessment, preliminary biochemical efficacy at 6 months, quality of life questionnaires, and pharmacokinetic modelling of [177Lu]Lu-PSMA-617.Discussion:This is the first prospective study to combine EBRT and ADT with [177Lu]Lu-PSMA-617 in treatment naïve men with N1M0 prostate cancer, and thereby explores the novel application of [177Lu]Lu-PSMA-617 in curative intent treatment. It is considered likely that this study will confirm tolerability as the combined toxicity of these treatments is expected to be limited. Increased efficacy is considered likely since both individual treatments have proven high anti-tumour effect as mono-treatments.Trial registration:ClinicalTrials, NCT05162573 . Registered 7 October 2021.

Primary Outcome Measures is Maximum tolerated dose (MTD); Extracted Interventionsis is 177Lu-PSMA-617 EBRT; Conditions is Prostatic Neoplasm ;Sex is MALE ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Characterization of Influenza-Like Illness Burden Using Commercial Wearable Sensor Data and Patient-Reported Outcomes: Mixed Methods Cohort Study.Background:The burden of influenza-like illness (ILI) is typically estimated via hospitalizations and deaths. However, ILI-associated morbidity that does not require hospitalization remains poorly characterized.Objective:The main objective of this study was to characterize ILI burden using commercial wearable sensor data and investigate the extent to which these data correlate with self-reported illness severity and duration. Furthermore, we aimed to determine whether ILI-associated changes in wearable sensor data differed between care-seeking and non-care-seeking populations as well as between those with confirmed influenza infection and those with ILI symptoms only.Methods:This study comprised participants enrolled in either the FluStudy2020 or the Home Testing of Respiratory Illness (HTRI) study; both studies were similar in design and conducted between December 2019 and October 2020 in the United States. The participants self-reported ILI-related symptoms and health care-seeking behaviors via daily, biweekly, and monthly surveys. Wearable sensor data were recorded for 120 and 150 days for FluStudy2020 and HTRI, respectively. The following features were assessed: total daily steps, active time (time spent with >50 steps per minute), sleep duration, sleep efficiency, and resting heart rate. ILI-related changes in wearable sensor data were compared between the participants who sought health care and those who did not and between the participants who tested positive for influenza and those with symptoms only. Correlative analyses were performed between wearable sensor data and patient-reported outcomes.Results:After combining the FluStudy2020 and HTRI data sets, the final ILI population comprised 2435 participants. Compared with healthy days (baseline), the participants with ILI exhibited significantly reduced total daily steps, active time, and sleep efficiency as well as increased sleep duration and resting heart rate. Deviations from baseline typically began before symptom onset and were greater in the participants who sought health care than in those who did not and greater in the participants who tested positive for influenza than in those with symptoms only. During an ILI event, changes in wearable sensor data consistently varied with those in patient-reported outcomes.Conclusions:Our results underscore the potential of wearable sensors to discriminate not only between individuals with and without influenza infections but also between care-seeking and non-care-seeking populations, which may have future application in health care resource planning.Trial registration:Clinicaltrials.gov NCT04245800; https://clinicaltrials.gov/ct2/show/NCT04245800.

Primary Outcome Measures is Detection of RVI cases through the use of behavioral data and patient-reported outcomes; Extracted Interventionsis is nan; Conditions is Influenza -Like Illness|Influenza A|Influenza Type B|Respiratory Viral Infection|Respiratory Tract Infections ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Acute Effects of Coffee Consumption on Health among Ambulatory Adults.Background:Coffee is one of the most commonly consumed beverages in the world, but the acute health effects of coffee consumption remain uncertain.Methods:We conducted a prospective, randomized, case-crossover trial to examine the effects of caffeinated coffee on cardiac ectopy and arrhythmias, daily step counts, sleep minutes, and serum glucose levels. A total of 100 adults were fitted with a continuously recording electrocardiogram device, a wrist-worn accelerometer, and a continuous glucose monitor. Participants downloaded a smartphone application to collect geolocation data. We used daily text messages, sent over a period of 14 days, to randomly instruct participants to consume caffeinated coffee or avoid caffeine. The primary outcome was the mean number of daily premature atrial contractions. Adherence to the randomization assignment was assessed with the use of real-time indicators recorded by the participants, daily surveys, reimbursements for date-stamped receipts for coffee purchases, and virtual monitoring (geofencing) of coffee-shop visits.Results:The mean (±SD) age of the participants was 39±13 years; 51% were women, and 51% were non-Hispanic White. Adherence to the random assignments was assessed to be high. The consumption of caffeinated coffee was associated with 58 daily premature atrial contractions as compared with 53 daily events on days when caffeine was avoided (rate ratio, 1.09; 95% confidence interval [CI], 0.98 to 1.20; P = 0.10). The consumption of caffeinated coffee as compared with no caffeine consumption was associated with 154 and 102 daily premature ventricular contractions, respectively (rate ratio, 1.51; 95% CI, 1.18 to 1.94); 10,646 and 9665 daily steps (mean difference, 1058; 95% CI, 441 to 1675); 397 and 432 minutes of nightly sleep (mean difference, 36; 95% CI, 25 to 47); and serum glucose levels of 95 mg per deciliter and 96 mg per deciliter (mean difference, -0.41; 95% CI, -5.42 to 4.60).Conclusions:In this randomized trial, the consumption of caffeinated coffee did not result in significantly more daily premature atrial contractions than the avoidance of caffeine. (Funded by the University of California, San Francisco, and the National Institutes of Health; CRAVE ClinicalTrials.gov number, NCT03671759.).

Primary Outcome Measures is Change in PAC frequency; Extracted Interventionsis is Start Start; Conditions is Premature Atrial Contractions|Premature Ventricular Contractions ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis.Background:Lebrikizumab, a high-affinity IgG4 monoclonal antibody targeting interleukin-13, prevents the formation of the interleukin-4Rα-interleukin-13Rα1 heterodimer receptor signaling complex.Methods:We conducted two identically designed, 52-week, randomized, double-blind, placebo-controlled, phase 3 trials; both trials included a 16-week induction period and a 36-week maintenance period. Eligible patients with moderate-to-severe atopic dermatitis (adults [≥18 years of age] and adolescents [12 to <18 years of age, weighing ≥40 kg]) were randomly assigned in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks. Outcomes for the induction period were assessed up to 16 weeks and are included in this report. The primary outcome was an Investigator's Global Assessment (IGA) score of 0 or 1 (indicating clear or almost clear skin; range, 0 to 4 [severe disease]) with a reduction (indicating improvement) of at least 2 points from baseline at week 16. Secondary outcomes included a 75% improvement in the Eczema Area and Severity Index score (EASI-75 response) and assessments of itch and of itch interference with sleep. Safety was also assessed.Results:In trial 1, the primary outcome was met in 43.1% of 283 patients in the lebrikizumab group and in 12.7% of 141 patients in the placebo group (P<0.001); an EASI-75 response occurred in 58.8% and 16.2%, respectively (P<0.001). In trial 2, the primary outcome was met in 33.2% of 281 patients in the lebrikizumab group and in 10.8% of 146 patients in the placebo group (P<0.001); an EASI-75 response occurred in 52.1% and 18.1%, respectively (P<0.001). Measures of itch and itch interference with sleep indicated improvement with lebrikizumab therapy. The incidence of conjunctivitis was higher among patients who received lebrikizumab than among those who received placebo. Most adverse events during the induction period were mild or moderate in severity and did not lead to trial discontinuation.Conclusions:In the induction period of two phase 3 trials, 16 weeks of treatment with lebrikizumab was effective in adolescents and adults with moderate-to-severe atopic dermatitis. (Funded by Dermira; ADvocate1 and ADvocate2 ClinicalTrials.gov numbers, NCT04146363 and NCT04178967, respectively.).

Primary Outcome Measures is Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16; Extracted Interventionsis is Lebrikizumab Placebo; Conditions is Atopic Dermatitis ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Antidepressant Augmentation versus Switch in Treatment-Resistant Geriatric Depression.Background:The benefits and risks of augmenting or switching antidepressants in older adults with treatment-resistant depression have not been extensively studied.Methods:We conducted a two-step, open-label trial involving adults 60 years of age or older with treatment-resistant depression. In step 1, patients were randomly assigned in a 1:1:1 ratio to augmentation of existing antidepressant medication with aripiprazole, augmentation with bupropion, or a switch from existing antidepressant medication to bupropion. Patients who did not benefit from or were ineligible for step 1 were randomly assigned in step 2 in a 1:1 ratio to augmentation with lithium or a switch to nortriptyline. Each step lasted approximately 10 weeks. The primary outcome was the change from baseline in psychological well-being, assessed with the National Institutes of Health Toolbox Positive Affect and General Life Satisfaction subscales (population mean, 50; higher scores indicate greater well-being). A secondary outcome was remission of depression.Results:In step 1, a total of 619 patients were enrolled; 211 were assigned to aripiprazole augmentation, 206 to bupropion augmentation, and 202 to a switch to bupropion. Well-being scores improved by 4.83 points, 4.33 points, and 2.04 points, respectively. The difference between the aripiprazole-augmentation group and the switch-to-bupropion group was 2.79 points (95% CI, 0.56 to 5.02; P = 0.014, with a prespecified threshold P value of 0.017); the between-group differences were not significant for aripiprazole augmentation versus bupropion augmentation or for bupropion augmentation versus a switch to bupropion. Remission occurred in 28.9% of patients in the aripiprazole-augmentation group, 28.2% in the bupropion-augmentation group, and 19.3% in the switch-to-bupropion group. The rate of falls was highest with bupropion augmentation. In step 2, a total of 248 patients were enrolled; 127 were assigned to lithium augmentation and 121 to a switch to nortriptyline. Well-being scores improved by 3.17 points and 2.18 points, respectively (difference, 0.99; 95% CI, -1.92 to 3.91). Remission occurred in 18.9% of patients in the lithium-augmentation group and 21.5% in the switch-to-nortriptyline group; rates of falling were similar in the two groups.Conclusions:In older adults with treatment-resistant depression, augmentation of existing antidepressants with aripiprazole improved well-being significantly more over 10 weeks than a switch to bupropion and was associated with a numerically higher incidence of remission. Among patients in whom augmentation or a switch to bupropion failed, changes in well-being and the occurrence of remission with lithium augmentation or a switch to nortriptyline were similar. (Funded by the Patient-Centered Outcomes Research Institute; OPTIMUM ClinicalTrials.gov number, NCT02960763.).

Primary Outcome Measures is Psychological Well-Being; Extracted Interventionsis is Aripiprazole Augmentation Bupropion Augmentation Switch to bupropion Lithium Augmentation Switch to nortriptyline; Conditions is Treatment Resistant Depression|Major Depressive Disorder|Treatment-Refractory Depression|Late Life Depression|Geriatric Depression ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.A phase 2 study of interleukin-22 and systemic corticosteroids as initial treatment for acute GVHD of the lower GI tract.Graft-versus-host disease (GVHD) is a major cause of morbidity and mortality following allogeneic hematopoietic transplantation. In experimental models, interleukin-22 promotes epithelial regeneration and induces innate antimicrobial molecules. We conducted a multicenter single-arm phase 2 study evaluating the safety and efficacy of a novel recombinant human interleukin-22 dimer, F-652, used in combination with systemic corticosteroids for treatment of newly diagnosed lower gastrointestinal acute GVHD. The most common adverse events were cytopenias and electrolyte abnormalities, and there were no dose-limiting toxicities. Out of 27 patients, 19 (70%; 80% confidence interval, 56%-79%) achieved a day-28 treatment response, meeting the prespecified primary endpoint. Responders exhibited a distinct fecal microbiota composition characterized by expansion of commensal anaerobes, which correlated with increased overall microbial α-diversity, suggesting improvement of GVHD-associated dysbiosis. This work demonstrates a potential approach for combining immunosuppression with tissue-supportive strategies to enhance recovery of damaged mucosa and promote microbial health in patients with gastrointestinal GVHD. This trial was registered at www.clinicaltrials.gov as NCT02406651.

Primary Outcome Measures is The Number of Participants With Lower Gastrointestinal Acute Graft-Versus-Host-Disease Treatment Response Rate on Day 28; Extracted Interventionsis is Recombinant Human Interleukin-22 IgG2-Fc (F-652) Systemic Corticosteroids; Conditions is Acute Graft vs Host Disease ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Effectiveness of high-flow nasal cannulae compared with noninvasive positive-pressure ventilation in preventing reintubation in patients receiving prolonged mechanical ventilation.Many intensive care unit patients who undergo endotracheal extubation experience extubation failure and require reintubation. Because of the high mortality rate associated with reintubation, postextubation respiratory management is crucial, especially for high-risk populations. We conducted the present study to compare the effectiveness of oxygen therapy administered using high-flow nasal cannulae (HFNC) and noninvasive positive pressure ventilation (NIPPV) in preventing reintubation among patients receiving prolonged mechanical ventilation (PMV). This single-center, prospective, unblinded randomized controlled trial was at the respiratory care center (RCC). Participants were randomized to an HFNC group or an NIPPV group (20 patients in each) and received noninvasive respiratory support (NRS) administered using their assigned method. The primary outcome was reintubation within7 days after extubation. None of the patients in the NIPPV group required reintubation, whereas 5 (25%) of the patients in the HFNC group required reintubation (P = 0.047). The 90-day mortality rates of the NIPPV and HFNC groups (four patients [20%] vs. two patients [10%], respectively) did not differ significantly. No significant differences in length of RCC stay, length of hospital stay, time to liberation from NRS, and ventilator-free days at 28-day were identified. The time to event outcome analysis also revealed that the risk of reintubation in the HFNC group was higher than that in the NIPPV group (P = 0.018). Although HFNC is becoming increasingly common as a form of postextubation NRS, HFNC may not be as effective as NIPPV in preventing reintubation among patients who have been receiving PMV for at least 2 weeks. Additional studies evaluating HFNC as an alternative to NIPPV for patients receiving PMV are warranted.ClinicalTrial.gov ID: NCT04564859; IRB number: 20160901R.Trial registration: ClinicalTrial.gov ( https://clinicaltrials.gov/ct2/show/NCT04564859 ).

Primary Outcome Measures is Re-intubation rate; Extracted Interventionsis is Heated Humidified High-Flow Nasal Cannula; Conditions is Critically Illness ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Psychometric evaluation of the NTDT-PRO questionnaire for assessing symptoms in patients with non-transfusion-dependent beta-thalassaemia.Objectives:The non-transfusion-dependent beta-thalassaemia-patient-reported outcome (NTDT-PRO) questionnaire was developed for assessing anaemia-related tiredness/weakness (T/W) and shortness of breath (SoB) among patients with NTDT. Psychometric properties were evaluated using blinded data from the BEYOND trial (NCT03342404).Design:Analysis of a phase 2, double-blind, randomised, placebo-controlled trial.Setting:USA, Greece, Italy, Lebanon, Thailand and the UK.Participants:Adults (≥18 years) (N=145) with NTDT who had not received a red blood cell transfusion within 8 weeks prior to randomisation, with mean baseline haemoglobin level ≤100 g/L.Measures:NTDT-PRO daily scores from baseline until week 24, and scores at select time points for the 36-Item Short Form Health Survey version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Patient Global Impression of Severity (PGI-S).Results:Cronbach's alpha at weeks 13-24 was 0.95 and 0.84 for the T/W and SoB domains, respectively, indicating acceptable internal consistency reliability. Among participants self-reporting no change in thalassaemia symptoms via the PGI-S between baseline and week 1, intraclass correlation coefficients were 0.94 and 0.92 for the T/W and SoB domains, respectively, indicating excellent test-retest reliability. In a known-groups validity analysis, least-squares mean T/W and SoB scores at weeks 13-24 were worse in participants with worse scores for the FACIT-F Fatigue Subscale (FS), SF-36v2 vitality or PGI-S. Indicating responsiveness, changes in T/W and SoB domain scores were moderately correlated with changes in haemoglobin levels, and strongly correlated with changes in SF-36v2 vitality, FACIT-F FS, select FACIT-F items and the PGI-S. Improvements in least-squares mean T/W and SoB scores were higher in participants with greater improvements in scores on other PROs measuring similar constructs.Conclusions:The NTDT-PRO demonstrated adequate psychometric properties to assess anaemia-related symptoms in adults with NTDT and can be used to evaluate treatment efficacy in clinical trials.

Primary Outcome Measures is Percentage of Participants Achieving Erythroid Response (Week 13 to Week 24); Extracted Interventionsis is Luspatercept Placebo Best Supportive Care (BSC); Conditions is Thalassemia ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study.Objective: Patients with early-phase schizophrenia or bipolar I disorder (BD-I) are at greater risk for antipsychotic-associated weight gain. This 12-week, randomized, double-blind study conducted between June 2017 and December 2021 evaluated weight effects of combination olanzapine and samidorphan (OLZ/SAM) versus olanzapine in early-phase illness.Methods: Young adults (16-39 years) with DSM-5 schizophrenia, schizophreniform disorder, or BD-I, < 4 years since symptom onset, body mass index < 30 kg/m2, and < 24 weeks' cumulative antipsychotic exposure were randomized to OLZ/SAM (5-20/10 mg/d) or olanzapine (5-20 mg/d). Primary endpoint was percent change from baseline body weight at week 12. Secondary endpoints, tested hierarchically, were proportions of patients with ≥ 10% or ≥ 7% weight gain, waist circumference change, and Clinical Global Impressions-Severity (CGI-S) change.Results: Of 428 patients (OLZ/SAM, n = 213; olanzapine, n = 215), 408 had ≥ 1 postbaseline weight assessment and were analyzed. Percent weight change was significantly lower with OLZ/SAM versus olanzapine (4.91% vs 6.77%; least-squares mean [LSM] [SE] difference, -1.87% [0.75]; P = .012). Although fewer patients treated with OLZ/SAM had ≥ 10% weight gain, the difference was not statistically significant versus olanzapine (21.9% vs 30.4%, respectively; OR = 0.64; 95% CI = 0.39 to 1.05); hierarchical testing precluded further statistical evaluation of secondary endpoints. Proportions of patients with ≥ 7% weight gain (33.1% vs 44.8%; OR = 0.61, 95% CI = 0.39 to 0.94) and waist circumference change (2.99 vs 3.90 cm; LSM [SE] difference, -0.92 cm [0.58]; 95% CI = -2.06 to 0.22) favored OLZ/SAM. LSM (SE) CGI-S change with OLZ/SAM was -0.82 (0.06). OLZ/SAM and olanzapine had similar safety profiles, including small, similar metabolic parameter changes.Conclusions: In patients with early-phase schizophrenia, schizophreniform disorder, or BD-I, OLZ/SAM treatment resulted in less weight gain versus olanzapine.Trial Registration: ClinicalTrials.gov identifier: NCT03187769.

Primary Outcome Measures is Percent Change From Baseline in Body Weight at Week 12; Extracted Interventionsis is ALKS 3831 Olanzapine; Conditions is Schizophrenia|Schizophreniform Disorders|Bipolar I Disorder ;Sex is ALL ;Age is CHILD, ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Adverse Events and Measurement of Dissociation After the First Dose of Esketamine in Patients With TRD.Background:"Dissociation" comprises distinct phenomena, some of which are associated with esketamine treatment and some may overlap with positive symptoms of psychosis. Relationships between dissociation and psychotic symptoms assessed by -clinician report vs conventional rating scales were investigated in a post hoc analysis of data from the initial treatment session in an -open-label, -long-term safety, phase 3 study of esketamine plus a newly initiated oral antidepressant in patients with treatment-resistant depression.Methods:Adverse events of dissociation or psychosis were examined via investigator report and the Clinician Administered Dissociative States Scale (CADSS) and Brief Psychiatric Rating Scale-Plus, respectively, 40 minutes post first esketamine dose. The range of CADSS total scores associated with investigator-reported severity of dissociation was determined by equipercentile linking. Logistic regression models and receiver operating curve analysis explored the CADSS cutoff point for determining presence/absence of dissociation. Frequency of response to specific CADSS items was examined to investigate qualitative differences in the pattern of symptoms reported across investigator-reported levels of adverse event severity.Results:Dissociation was reported as an adverse event in 14.3% (109/764) of patients. Severity of most CADSS items increased with the severity of investigator-reported dissociation. No CADSS cutoff point discriminated well between the presence and absence of dissociation events. Hallucinations were reported as adverse events in 5 patients; none reported delusions.Conclusions:CADSS scores and severity of dissociation adverse events move generally in the same direction; however, there is substantial variability in this relationship. No signature profile of dissociative experiences was revealed, and psychotic symptoms were uncommon.Trial registration:Clinical Trials.gov identifier: NCT02497287.

Primary Outcome Measures is Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs); Extracted Interventionsis is Esketamine (Intranasal Spray) Duloxetine (Oral Antidepressant) Escitalopram (Oral Antidepressant) Sertraline (Oral Antidepressant) Venlafaxine Extended Release (XR) (Oral Antidepressant); Conditions is Treatment-resistant Depression ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Facebook Intervention to Connect Alaska Native People With Resources and Support to Quit Smoking: CAN Quit Pilot Randomized Controlled Trial.Introduction:There is some evidence that social media interventions can promote smoking cessation. This randomized controlled pilot study is the first to evaluate the feasibility and potential efficacy of a Facebook smoking cessation intervention among Alaska Native (AN) adults.Aims and methods:Recruitment and data collection occurred from December 2019 to March 2021. Participants were recruited statewide in Alaska using Facebook advertisements with a targeted sample of 60 enrolled. Participants were stratified by gender, age, and rural or urban residence and randomly assigned to receive referral resources on evidence-based cessation treatments (EBCTs) (control, n = 30) or these resources plus a 3-month, closed (private), culturally tailored, Facebook group (intervention, n = 31) that connected participants to EBCT resources and was moderated by two Alaska Native Trained Tobacco Specialists. Assessments were conducted online post-randomization at 1, 3, and 6 months. Outcomes were feasibility (recruitment, retention, and intervention engagement), self-reported use of EBCTs, and biochemically confirmed seven-day point-prevalence smoking abstinence.Results:Of intervention participants, 90% engaged (eg posted, commented) more than once. Study retention was 57% at 6 months (no group differences). The proportion utilizing EBCTs was about double for intervention compared with the control group participants at 3 and 6 months. Smoking abstinence was higher for intervention than control participants at 3 months (6.5% vs. 0%, p = .16) but comparable at 6 months (6.4% vs. 6.7%, p = .97).Conclusions:While additional research is needed to promote long-term cessation, this pilot trial supports recruitment feasibility during the Coronavirus Disease 2019 (COVID-19) pandemic, consumer uptake, and a signal for intervention efficacy on the uptake of cessation treatment and short-term smoking abstinence.Implications:This study is the first evaluation of a social media intervention for smoking cessation among Indigenous people. We learned that statewide Facebook recruitment of AN adults who smoke was feasible and there was a signal for the efficacy of a Facebook intervention on the uptake of EBCT and short-term (3 months) biochemically verified smoking abstinence. Clinically, social media platforms may complement current care models by connecting AN individuals and others living in hard-to-reach communities to cessation treatment resources.

Primary Outcome Measures is Smoking Cessation Program Completion; Extracted Interventionsis is Facebook Group; Conditions is Tobacco Use|Tobacco Smoking|Tobacco Use Cessation|Smoking Cessation|Smoking, Cigarette|Smoking, Tobacco|Smoking ;Sex is ALL ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Impact of ¡Míranos! on parent-reported home-based healthy energy balance-related behaviors in low-income Latino preschool children: a clustered randomized controlled trial.Background:Widespread establishment of home-based healthy energy balance-related behaviors (EBRBs), like diet, physical activity, sedentary behavior, screen time, and sleep, among low-income preschool-aged children could curb the childhood obesity epidemic. We examined the effect of an 8-month multicomponent intervention on changes in EBRBs among preschool children enrolled in 12 Head Start centers.Methods:The Head Start (HS) centers were randomly assigned to one of three treatment arms: center-based intervention group (CBI), center-based plus home-based intervention group (CBI + HBI), or control. Before and following the intervention, parents of 3-year-olds enrolled in participating HS centers completed questionnaires about their child's at-home EBRBs. Adult-facilitated physical activity (PA) was measured by an index based on questions assessing the child's level of PA participation at home, with or facilitated by an adult. Fruit, vegetable, and added sugar intake were measured via a short food frequency questionnaire, and sleep time and screen time were measured using 7-day logs. A linear mixed effects model examined the intervention's effect on post-intervention changes in PA, intake of fruit, vegetable, and added sugar, sleep time, and screen time from baseline to post-intervention.Results:A total of 325 parents participated in the study (CBI n = 101; CBI + HBI n = 101; and control n = 123). Compared to control children, CBI and CBI + HBI parents reported decreases in children's intake of added sugar from sugar-sweetened beverages. Both CBI and CBI + HBI parents also reported smaller increases in children's average weekday screen time relative to controls. In addition, CBI + HBI parents reported CBI + HBI parents reported increases in children's adult-facilitated PA, fruit and vegetable intake, and daily sleep time during weekdays (excluding weekends) and the total week from baseline to post-intervention, while children in the CBI increased sleep time over the total week compared to the children in the control group.Conclusions:Parent engagement strengthened the improvement in parent-reported EBRBs at home in young children participating in an evidence-based obesity prevention program in a childcare setting. Future studies should investigate equity-related contextual factors that influence the impact of obesity prevention in health-disparity populations.Trial registration:ClinicalTrials.gov, NCT03590834. Registered July 18, 2018, https://clinicaltrials.gov/ct2/show/NCT03590834.

Primary Outcome Measures is Change in Body Mass Index; Extracted Interventionsis is Center-based Intervention Home-based Intervention Active Control; Conditions is Obesity|Healthy Eating|Physical Activity|Health Knowledge, Attitudes, Practice|Gross Motor Development ;Sex is ALL ;Age is CHILD

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.One year follow-up on a randomized study investigating serratus anterior muscle and pectoral nerves type I block to reduced neuropathic pain descriptors after mastectomy.Breast cancer is the second most common diagnosed type of cancer in women. Chronic neuropathic pain after mastectomy occurs frequently and is a serious health problem. In our previous single-center, prospective, randomized controlled clinical study, we demonstrated that the combination of serratus anterior plane block (SAM) and pectoral nerve block type I (PECS I) with general anesthesia reduced acute postoperative pain. The present report describes a prospective follow-up study of this published study to investigate the development of chronic neuropathic pain 12 months after mastectomy by comparing the use of general anesthesia alone and general anesthesia with SAM + PECS I. Additionally, the use of analgesic medication, quality of life, depressive symptoms, and possible correlations between plasma levels of interleukin (IL)-1 beta, IL-6, and IL-10 collected before and 24 h after surgery as predictors of pain and depression were evaluated. The results showed that the use of SAM + PECS I with general anesthesia reduced numbness, hypoesthesia to touch, the incidence of patients with chronic pain in other body regions and depressive symptoms, however, did not significantly reduce the incidence of chronic neuropathic pain after mastectomy. Additionally, there was no difference in the consumption of analgesic medication and quality of life. Furthermore, no correlation was observed between IL-1 beta, IL-6, and IL-10 levels and pain and depression. The combination of general anesthesia with SAM + PECS I reduced the occurrence of specific neuropathic pain descriptors and depressive symptoms. These results could promote the use of SAM + PECS I blocks for the prevention of specific neuropathic pain symptoms after mastectomy.Registration of clinical trial: The Research Ethics Board of the Hospital Sirio-Libanes/Brazil approved the study (CAAE 48721715.0.0000.5461). This study is registered at Registro Brasileiro de Ensaios Clinicos (ReBEC), and ClinicalTrials.gov, Identifier: NCT02647385.

Primary Outcome Measures is Patient´s Pain assessment; Extracted Interventionsis is Block with lidocaine for SAM and PEC I block; Conditions is Breast Cancer|Anesthesia ;Sex is FEMALE ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Paliperidone ER versus risperidone for neurocognitive function in patients with schizophrenia: a randomized, open-label, controlled trial.This study aims to determine the effectiveness of paliperidone extended release (ER) on cognitive function in patients with schizophrenia in comparison with risperidone. This was a 12-week, randomized, open-label study on schizophrenia patients who were receiving risperidone. The patients were randomized to a risperidone-continuation group or a paliperidone-switch group. The primary outcome measure was neurocognitive function, which was measured using a computerized battery. Secondary efficacy measures included the Positive and Negative Syndrome Scale, Social and Occupational Functioning Scale, and Calgary Depression Scale for Schizophrenia. In total, 58 patients participated in this trial. Improvements in recall after an interference phase in the verbal learning test were significantly greater in the paliperidone-switch than in the risperidone-continuation group. No significant differences in changes were observed in the other six neurocognitive domains measured. Improvements in the Social and Occupational Functioning Scale were significantly greater in the paliperidone ER-switch group than in the risperidone-continuation group. In other efficacy outcome measures, no significant differences were observed between the two drugs. Paliperidone ER had a side-effect profile similar to that of risperidone, including metabolic problems and prolactin-related adverse events. In conclusion, switching from risperidone to paliperidone ER may lead to additional cognitive and social functional improvements.

Primary Outcome Measures is Neurocognitive function; Extracted Interventionsis is Paliperidone ER Risperidone; Conditions is Schizophrenia ;Sex is ALL ;Age is ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Eldecalcitol normalizes bone turnover markers regardless of their pre-treatment levels.Background:Three-year treatment with eldecalcitol has been shown to improve lumbar and total hip bone mineral density (BMD), decrease bone turnover markers, and lower the incidences of vertebral and wrist fractures in patients with osteoporosis more than with treatment with alfacalcidol under vitamin D repletion. The purpose of this study was to determine whether there was a risk of eldecalcitol causing severely suppressed bone turnover in osteoporosis patients with low pre-treatment levels of bone turnover markers.Methods and results:Post-hoc analysis was conducted on the data from a 3-year, randomized, double-blind, active-comparator, clinical trial of eldecalcitol versus alfacalcidol under vitamin D repletion conducted in Japan. Enrolled patients with baseline measurements of bone turnover markers were stratified into tertiles according to their pre-treatment levels of serum bone-specific alkaline phosphatase, serum procollagen type I N-terminal propeptide, or urinary collagen-N-telopeptide. Eldecalcitol treatment rapidly reduced bone turnover markers, and kept them within the normal range. However, in the patients whose baseline values for bone turnover were low, eldecalcitol treatment did not further reduce bone turnover markers during the 3-year treatment period. Further long-term observation may be required to reach the conclusion. CLINICALTRIALS.GOV NUMBER: NCT00144456.Conclusions:Eldecalcitol normalizes, but does not overly suppress, bone turnover regardless of baseline levels of bone turnover markers. Thus, it is unlikely that eldecalcitol treatment will increase the risk of severely suppressed bone turnover and therefore deterioration of bone quality, at least for a treatment duration of 3 years.

Primary Outcome Measures is Incidences of vertebral fracture; Extracted Interventionsis is ED-71 Alfacalcidol ED-71 placebo Alfacalcidol placebo; Conditions is Osteoporosis ;Sex is ALL ;Age is CHILD, ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.Background and objective:Approximately 75% of postmenopausal women experience vasomotor symptoms (hot flashes). Currently, hormone replacement therapy is the only approved treatment for hot flashes. However, its use has been associated with an increased risk of invasive breast cancer, coronary heart disease, stroke and venous thromboembolic disease. Gabapentin has also been demonstrated to be efficacious in the treatment of vasomotor symptoms in postmenopausal women when administered three times a day. A gastroretentive extended-release formulation of gabapentin (gabapentin-ER) has recently been demonstrated to be efficacious in the treatment of postmenopausal hot flashes. The objective of this paper is to report the steady-state pharmacokinetics and safety of gabapentin with different dosing regimens of gabapentin-ER in postmenopausal women with hot flashes.Methods:This was a multicentre, randomized, double-blind, dose-escalating, placebo-controlled, parallel group study in 124 postmenopausal women experiencing ≥7 moderate to severe hot flashes per day. The study consisted of two 5-week treatment periods, with each one preceded by a 1-week titration to the assigned dose. Groups A, B and C received gabapentin-ER 600 mg evening (pm), 600 mg morning (am)/600 mg pm and 1200 mg pm in the first period, and then 600 mg am/1200 mg pm, 600 mg am/1800 mg pm and 1200 mg am/1800 mg pm in the second period, respectively. The tablets were taken after a non-specified meal. Pharmacokinetic sampling was conducted over a 24-hour period at the end of each study period. Plasma samples were analysed by a validated liquid chromatography tandem mass spectrometry method. Non-compartmental pharmacokinetic analysis was performed on the concentration-time data to determine area under the plasma concentration versus time curve from time zero to 24 hours (AUC(24)). Maximum (C(max)), minimum (C(min)) and average (C(avg)) drug concentration and time to reach C(max) (t(max)) were determined by inspection of the data. Tolerability was evaluated by physical examination, clinical laboratory measurements and adverse events monitoring.Results:Gabapentin exposure at steady state, as measured by AUC(24), increased with doses from 600 mg/day to 3000 mg/day, although there was a slight decrease in gabapentin's relative bioavailability with increasing dose compared with the 600 mg dose. The relative bioavailability compared with the 600 mg dose was 86-88% for the 1200 mg/day doses, 75% for the 1800 mg/day dose, 84% for the 2400 mg/day dose, and 73% for the 3000 mg/day dose. C(max) generally increased with increasing dose as did C(min) and C(avg) for the various treatments in a manner that was consistent with the dosing regimen. The values of t(max) were not different between the various doses, with the median t(max) values relative to the most recent dose ranging from 6 to 8 hours for all dose levels. Gabapentin-ER was generally well tolerated at all doses studied. The most common AEs were headache, dizziness and somnolence, with most being mild in intensity. Seven patients withdrew from the study due to AEs.Conclusion:The pharmacokinetic profile of gabapentin-ER may allow for once- or twice-daily dosing while maintaining bioavailability and thus efficacy. Gabapentin-ER was well tolerated.Clinical trial registration:Registered as ClinicalTrials.gov Identifier: NCT00511953.

Primary Outcome Measures is Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period; Extracted Interventionsis is Gabapentin Extended Release tablets Gabapentin; Conditions is Hot Flashes ;Sex is FEMALE ;Age is ADULT, OLDER_ADULT

Extract PICO elements from the following titles and abstracts, including gender, age, condition, intervention, and outcome.Oral mucosal decontamination with chlorhexidine for the prevention of ventilator-associated pneumonia in children - a randomized, controlled trial.Objective:To study the efficacy of oral mucosal decontamination with chlorhexidine gel for the prevention of ventilator-associated pneumonia in children between 3 months and 15 yrs.Design:Double blind randomized placebo controlled trial.Setting:Pediatric intensive care unit of a tertiary care hospital in North India.Patients:Eligible participants were patients aged 3 months to 15 yrs who required orotracheal or nasotracheal intubation and mechanical ventilation. Two hundred eighty-three children admitted to the pediatric intensive care unit between November 2007 and April 2009 were screened. Eighty-six patients fulfilled the study requirements.Intervention:Either 1% chlorhexidine or placebo gel was applied on the buccal mucosa at 8-hr intervals for the entire duration of ventilation, subject to a maximum of 21 days. Patients were followed up for the development of ventilator-associated pneumonia, diagnosed using the Centers for Disease Control and Prevention criteria.Main outcome measures:Incidence of ventilator-associated pneumonia, duration of hospital stay, duration of intensive care unit stay, mortality, and characteristics of organisms isolated.Results:Fourty-one children received 1% chlorhexidine, whereas 45 received placebo application. Patients of both groups were comparable with respect to baseline characteristics. Incidence of ventilator-associated pneumonia was 39.6/1,000 ventilator days with 1% chlorhexidine and 38.1/1,000 ventilator days with placebo (relative risk 1.03, confidence interval 0.44-2.42, p = .46). The duration of intensive care unit stay and hospital stay was a mean of 8.4 ± 5.8 vs. 9.6 ± 11.4 days (p = .58) and 16.1 ± 10.2 days vs. 15.1 ± 14.3 days (p = .19) with chlorhexidine and placebo, respectively. The mortality rates were similar in the two groups (p = .81). All but two isolates causing ventilator-associated pneumonia were gram-negative, with Acinetobacter species being the most common (14 of 26). No side effects of the applied gel were seen in either group.Conclusion:Oral mucosal application on 1% chlorhexidine gel did not prevent the development of ventilator-associated pneumonia in children 3 months to 15 yrs age.

Primary Outcome Measures is Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria; Extracted Interventionsis is Chlorhexidine gel Placebo gel; Conditions is Ventilator Associated Pneumonia ;Sex is ALL ;Age is CHILD