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Objective: Mirtazapine and SSRIs are widely prescribed as first-line agents for late-life depression. However, evidence for these drugs is mostly based on non-elderly patients. Therefore, we reanalyzed a randomized controlled trial of mirtazapine versus SSRIs for depression in a sub-population of late-life patients. Methods: A randomized controlled trial was conducted with 141 patients, of whom 41 were elderly, and 100 were non-elderly. This study compared SSRIs and mirtazapine in late-life depression, examined late-onset and early adult-onset separately and compared elderly and non-elderly patients for each drug. Treatment effects and adverse events were assessed using the Hamilton Depression Rating Scale and the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale, respectively. Results: In late-life depression, mirtazapine showed faster HAM-D total score improvement (3.3 points difference, p = 0.021) and higher improvement in insomnia (1.7 points difference, p = 0.001) and appetite (1.2 points difference, p = 0.020). Similar findings were observed for late-onset depression with the HAM-D total score (4.3 points difference, p = 0.007) and appetite (0.9 points difference, p = 0.004), favoring mirtazapine. Depressive symptoms were generally less improved in late-life depression than in non-late-life depression. Regarding the effect of mirtazapine on appetite, late-life depression showed greater improvement (0.7 points difference, p = 0.008). Nausea and micturition disturbances were more common with SSRIs in late-life depression than in non-late-life depression. In contrast, somnolence was less common in late-life depression with mirtazapine. Conclusion: The potential usefulness of mirtazapine in elderly patients was demonstrated. The results also showed differences in the treatment response to SSRIs and mirtazapine between elderly and non-elderly patients. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: To evaluate the efficacy of vaginal CO2 laser in women with stress predominant urinary incontinence (SUI) compared with the sham treatment. Methods: A randomized controlled trial with sham treatment was conducted between January 2019 and April 2021. Women with predominant SUI were recruited and randomized into two groups: the CO2 laser group (n = 29) and the sham group (n = 30). The International Consultation on Continence Questionnaire—Urinary Incontinence Short Form (ICIQ-UI SF) was used to evaluate the efficacy at 3 months postoperatively. All participants in both groups were advised to perform pelvic floor muscle training (PFMT) after the intervention. Results: A total of 59 women were studied. A total of 29 women were included in the CO2 laser group and 30 women were included in the sham group. The baseline scores of the ICIQ-UI SF were similar in both groups. A significant improvement in urinary incontinence scores was found in both groups 3 months after treatment (p < 0.001). However, there were no statistically significant differences between the two groups at 3 months (p = 0.8281). There were no changes in bladder neck descent or levator hiatal area immediately after intervention or 3 months after completion of treatment in either group. Most participants who received the active intervention reported mild vaginal pain during the procedure that resolved spontaneously at the end of treatment. Conclusions: Fractional CO2 laser treatment does not provide any benefit over the sham technique in alleviating SUI symptoms. The improvement in SUI symptoms in both groups might be related to PFMT. This study was registered with the Thai Clinical Trial Register (TCTR20190131004). [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The objective was to study the effect of immediate pre-operative warm-up using virtual reality simulation on intraoperative robot-assisted laparoscopic hysterectomy (RALH) performance by gynecology trainees (residents and fellows). Methods: We randomized the first, non-emergent RALH of the day that involved trainees warming up or not warming up. For cases assigned to warm-up, trainees performed a set of exercises on the da Vinci Skills Simulator immediately before the procedure. The supervising attending surgeon, who was not informed whether or not the trainee was assigned to warm-up, assessed the trainee's performance using the Objective Structured Assessment for Technical Skill (OSATS) and the Global Evaluative Assessment of Robotic Skills (GEARS) immediately after each surgery. Results: We randomized 66 cases and analyzed 58 cases (30 warm-up, 28 no warm-up), which involved 21 trainees. Attending surgeons rated trainees similarly irrespective of warm-up randomization with mean (SD) OSATS composite scores of 22.6 (4.3; warm-up) vs 21.8 (3.4; no warm-up) and mean GEARS composite scores of 19.2 (3.8; warm-up) vs 18.8 (3.1; no warm-up). The difference in composite scores between warm-up and no warm-up was 0.34 (95% CI: −1.44, 2.13), and 0.34 (95% CI: −1.22, 1.90) for OSATS and GEARS respectively. Also, we did not observe any significant differences in each of the component/subscale scores within OSATS and GEARS between cases assigned to warm-up and no warm-up. Conclusion: Performing a brief virtual reality-based warm-up before RALH did not significantly improve the intraoperative performance of the trainees. [ABSTRACT FROM AUTHOR]

Introduction: Femoral nerve block (FNB) is a well-established analgesic technique for TKA. However, it associates quadriceps weakness. Therefore, femoral triangle block (FTB) and adductor canal block (ACB) were proposed as effective alternative motor-spearing techniques. The primary objective was to compare quadriceps muscle strength preservation between FNB, FTB and ACB in TKA. The secondary objective was to analyze pain control and functional outcomes. Methods: This is a prospective, double-blinded RCT. From April 2018 to April 2019, patients who undergo a primary TKA were randomized into three experimental groups: FNB-G1/FTB-G2/ACB-G3. Quadriceps strength preservation was measured as the difference in maximum voluntary isometric contraction (MVIC) preoperatively and postoperatively. Results: Seventy-eight patients (G1, n = 22; G2, n = 26; G3, n = 30) met our inclusion/exclusion criteria. Patients with FNB retained significantly lower baseline MVIC at 6 h postoperatively (p = 0.001), but there were no differences at 24 and 48 h. There were no differences between the groups in functional outcomes at any time point. Patients in the FNB-G1 presented significant lower pain scores at 6 h (p = 0.01), 24 h (p = 0.005) and 48 h (p = 0.01). The highest cumulative opioid requirement was reported in ACB-G3. Conclusion: For patients undergoing TKA, FTB and ACB preserve quadriceps strength better than FNB at 6 h postoperatively, but there are no differences at 24 and 48 h. Moreover, this early inferiority does not translate to worse functional outcomes at any time point. FNB is associated with better pain control at 6, 24 and 48 h after surgery, while ACB presents the highest cumulative opioid requirement. Clinical trial registration: This study was registered in clinicaltrials.gov (NCT03518450; https://clinicaltrials.gov/ct2/show/NCT03518450; submitted March 17, 2018). [ABSTRACT FROM AUTHOR]

Purpose: To explore the theoretical constructs that functioned as mediators of interventions for moderate-to-vigorous physical activity (MVPA) maintenance among breast cancer survivors. Method: 161 survivors were randomized into 3 groups: Reach Plus, Reach Plus Message or Reach Plus Phone. All participants received a 3-month theory-based intervention delivered by volunteer coaches. During months 4–9, all participants monitored their MVPA and received feedback reports. Additionally, Reach Plus Message received weekly text/email messages and Reach Plus Phone received monthly calls from their coaches. Assessments of weekly MVPA minutes and theoretical constructs (self-efficacy, social support, physical activity [PA] enjoyment and PA barriers) were obtained at baseline, 3, 6, 9 and 12-months. Analyses: Using a multiple mediator analysis with a product of coefficients approach, we examined mechanisms associated with between-group differences over time in weekly MVPA minutes. Results: Self-efficacy mediated effects of Reach Plus Message vs. Reach Plus at 6 (ab = 16.99) and 9 M (ab = 27.45); social support mediated effects at 6 (ab = 4.86), 9 (ab = 14.30) and 12 M (ab = 6.18). Self-efficacy mediated effects of Reach Plus Phone vs. Reach Plus at 6 (ab = 18.76), 9 (ab = 28.93) and 12 M (ab = 18.18). Social support mediated effects of Reach Plus Phone vs. Reach Plus Message at 6 (ab=-5.50) and 9 M (ab=-13.20); PA enjoyment mediated effects at 12 M (ab=-3.63). Conclusions: PA maintenance efforts should focus on strengthening breast cancer survivors' self-efficacy and obtaining social support. The trial was registered at ClinicalTrials.Gov: NCT02694640 (Feb. 26, 2016). [ABSTRACT FROM AUTHOR]

Needle-related procedures can cause pain and fear in children and may lead to avoidance of future medical care. The aim of this study is to investigate whether virtual reality hypnosis (VRH) is non-inferior to medical hypnosis (MH) by a trained healthcare provider in reducing pain in children. This non-inferiority randomized trial was conducted at a teaching hospital in the Netherlands. Children aged 6 to 18 years were randomized to treatment with VRH or MH. The primary outcome was self-reported pain, using the Wong-Baker FACES Scale (WBFS) with the non-inferiority margin defined as a difference of 1.5 points. Secondary outcomes included observer-reported pain (Numeric Rating Scale), fear (scored by children and observers with the Children's Fear Scale), blood pressure, heart rate, treatment satisfaction, and adverse effects. We randomized 138 children to VRH or MH treatment and included 114 children in the analyses (VRH n = 60, MH n = 54). We found non-inferiority for VRH compared to MH on patient-reported pain (mean difference = − 0.17, 95%CI − 1.01;0.66). Secondary outcomes were comparable between VRH and MH groups. Both treatments scored high on patient satisfaction (VRH median = 9.0, MH median = 10.0, p = 0.512). Conclusion: VRH may be an effective and safe treatment option besides MH for reducing patient-reported pain in children during a needle-related procedure. VRH was non-inferior to MH in patient-reported fear and both treatments were comparable in terms of patient-reported fear, observer-reported pain and fear, physical distress, and patient satisfaction. Trial registration: ICTRP https://trialsearch.who.int/, trial ID NL9385; date registered: 03/04/2021. What is Known: • Medical hypnosis is effective in reducing procedural distress in children during needle-related procedures. • Virtual reality (VR) is an audiovisual electronic device that guides users into an immersive three-dimensional environment. What is New: • This study shows that VR hypnosis is non-inferior to medical hypnosis in reducing pain and fear in children undergoing a needle-related procedure. • Both VR hypnosis and medical hypnosis were appreciated highly by children to distract them during needle-related procedures. [ABSTRACT FROM AUTHOR]

The effectiveness of cerebellar repetitive transcranial magnetic stimulation (rTMS) on motor dysfunction in patients with neurological disorders has received increasing attention because of its potential for neuromodulation. However, studies on the neuromodulatory effects, parameters, and safety of rTMS implementation in the cerebellum to alleviate motor dysfunction are limited. This systematic review aimed to evaluate the effectiveness and safety of cerebellar rTMS treatment for motor dysfunction caused by neurological disorders and to review popular stimulation parameters. Five electronic databases—Medline, Web of Science, Scopus, Cochrane Library, and Embase—were searched for relevant research published from inception to July 2022. All randomized controlled trials (RCTs) that reported the effects of cerebellar rTMS combined with behavioral rating scales on motor dysfunction were eligible for enrollment. Additionally, reference lists of the enrolled studies were manually checked. Among 1156 articles screened, 21 RCTs with 666 subjects were included. rTMS conducted on the cerebellum showed an improvement in stroke (spasticity, balance, and gait), cervical dystonia, Parkinson's disease (tremor), cerebellar ataxia, and essential tremor but not in multiple sclerosis. The 8-shaped coil with a diameter of 70 mm was determined as the most common therapeutic choice. None of the studies reported severe adverse events except mild side effects in three. Therefore, rTMS appears to be a promising and safe technique for the treatment of motor dysfunction, targeting the cerebellum to induce motor behavioral improvement. Further rigorous RCTs, including more samples and longer follow-up periods, are required to precisely explore the effective stimulation parameters and possible mechanisms. [ABSTRACT FROM AUTHOR]

Background: Honey is described as a wound healing agent. Many virtues have been attributed to it, in particular, antibacterial properties. The aim of our study was to evaluate its value in healing of wounds after wide excision on pilonidal cyst healing. Methods: A prospective randomized trial was conducted from March 2016 to February 2022 which included patients with a persistent non healed wound which required packing 6 weeks after pilonidal cyst excision. Patients were randomly allocated to simple alginate wick dressings or the same design plus honey. Results: Fifty patients were included in each arm. There were 57 men and 43 women. The median age was 22 years (range 19–28 years). The mean healing time was 61 (± 44) days in the wick + honey group compared to 78 (± 55) days in the simple alginate wick group (p = 0.094). There was no significant difference between the two groups in terms of time off work and time without physical activity The VQ-Dermato quality of life score was equivalent in both groups. Conclusions: Tolerability for honey dressings is good and is equivalent to that of alginate dressings in cavity wound care. This trial did not reach a significant difference in its primary endpoint but it shows the value of honey in this indication, although its use requires further study. Trial registration number: clinical trials NCT02485860 and EUDRACT: 2015-A00452-47 (10/03/2015). [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to explore the efficiency and safety of modified tissue-selecting therapy stapler combined with complete anal canal epithelial preservation operation (M-TST-CACP) in the treatment of circumferential mixed hemorrhoids. Methods: This was a single-center, statistical analyst-blinded, randomized controlled trial (RCT). A total of 306 patients were finally included for analysis. The efficiency (efficacy, recurrence, anal smoothness, quality of life, and wound healing time) and safety (anal incontinence, pain level, anal stenosis, urinary retention, perianal edema, and postoperative bleeding) were evaluated. The statistical difference in continuous data between M-TST-CACP group and procedure for prolapse and hemorrhoids (PPH) group was compared using t-test or Mann–Whitney U test. The statistical difference in counting data between the two groups were compared using Pearson χ2 test. Difference within each group in different time points was evaluated using repeated-measures analysis of variance. Results: M-TST-CACP group showed a higher cure rate (6 months: 74.51% vs. 64.71%, P = 0.044), lower recurrence (6 months: 0% vs. 4.58%, P = 0.015; 12 months: 0.65% vs. 5.88%, P = 0.010), lower anal incontinence score (1 month: 1.29 ± 1.17 vs. 1.93 ± 1.33; 3 months: 1.07 ± 0.87 vs. 1.59 ± 1.01; 6 months: 0.58 ± 0.61 vs. 1.00 ± 0.90; all P < 0.001), and lower rate of anal stenosis (1 month: 0% vs. 7.84%; 3 months: 0% vs. 9.80%; both P < 0.001) than the PPH group. Conclusions: M-TST-CACP had better efficiency and safety than the PPH, which could be a reasonable adoption for the surgeons to treat circumferential mixed hemorrhoids. [ABSTRACT FROM AUTHOR]

Background: Studies assessing the effects of parenting programs have focused on interventions delivered through face-to-face modalities. There is a need for research to evaluate the effects of online parenting programs on child development, such as the BEM Program ('Play Teaches Change' in English), an online play-based parenting program that teaches caregivers on how to introduce playful interactions into their daily household chores. Objective: To assess the effects of the BEM Program on child development and the quality of caregiver-child interaction. Method: A two-arm randomized controlled trial was conducted in a socioeconomically disadvantaged district of São Paulo city in Brazil. 129 children aged 12–23 months and their caregiver were randomly assigned to receive either the BEM Program for 8 weeks (intervention, n = 66) or standard child care (control, n = 63). Data were collected at baseline and endline of the intervention through home visits and online interviews. An intention-to-treat analysis was conducted. Results: The intervention showed positive effects on child development, by improving language development (Cohen's d = 0.20, 95%CI 0.08–0.47) and reduced intrusiveness (Cohen's d = 0.35, 95%CI 0.06–0.65) of caregiver-child interaction. No significant differences were observed in caregiver's repertoire and engagement in age-appropriate play activities with the child while doing the household chores, parenting sense of competence and perceived stress. Conclusions: Despite the small size and low adherence to the program, such promising results advance evidences for fully remote parenting programs and their effects on child development. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the short-term efficacy of low-concentration betamethasone mouthwash for severe erosive oral lichen planus (EOLP). Materials and method: In this randomized, investigator-blind, positive-controlled trial, OLP patients with erosive lesions received betamethasone mouthwash (0.137 mg/mL) or dexamethasone mouthwash (0.181 mg/mL) three times daily for 2 or 4 weeks and were followed up for 3 months to observe recurrence. The primary outcome was the week-2 reduction in erosive area. Results: Fifty-seven participants were randomized to betamethasone (n = 29) and dexamethasone (n = 28). At week 2, participants using betamethasone (n = 28) experienced a greater reduction in erosive area than gargling with dexamethasone (n = 26). Similarly, secondary outcomes, including the healing proportion of erosions, reduced pain level, reduction in atrophic area, Thongprasom score, and recurrence interval, showed the superiority of betamethasone. At week 4, betamethasone (n = 7) was not superior to dexamethasone (n = 15) in further reducing lesional area and pain level. No serious adverse events were documented. Conclusions: The 0.137 mg/mL compound betamethasone mouthwash exhibited significant efficacy in rapidly enhancing erosion healing within 2 weeks and extending the recurrence interval with a good safety profile. Clinical relevance: This study proved the significant efficacy of short-course 0.137 mg/mL betamethasone mouthwash therapy for treating erosion and pain, providing a novel topical agent for patients with severe EOLP. Trial registration: This study was prospectively registered at the International Clinical Trials Registry Platform (ChiCTR1800016507) on 5 June 2018. [ABSTRACT FROM AUTHOR]

Introduction: Upadacitinib, an oral selective Janus kinase (JAK) inhibitor, is used to treat moderate-to-severe atopic dermatitis (AD). Acne is the most common treatment-emergent adverse event in patients with AD treated with upadacitinib. In this post hoc analysis, we describe the acne events in Japanese patients with AD who received upadacitinib during the Rising Up study. Methods: In this phase 3, double-blind, 3-year trial evaluating the safety and efficacy of upadacitinib 15 mg or 30 mg in Japanese patients with moderate-to-severe AD, patients were randomized 1:1:1 to receive upadacitinib 15 mg, 30 mg, or placebo for up to 16 weeks. At week 16, placebo-treated patients were re-randomized 1:1 to receive upadacitinib 15 mg or 30 mg. The incidence, characteristics, and management of treatment-emergent acne events up to the 52-week cutoff date were summarized. Results: Among 272 patients in this analysis, the incidence of acne was higher in patients receiving upadacitinib compared with patients who received placebo. The rate of acne was higher in patients receiving upadacitinib 30 mg (32.4%) compared with those taking upadacitinib 15 mg (17.3%) during the long-term treatment period. All cases of acne were mild or moderate; no cases led to study drug discontinuation. The mean (range) of acne onset was 135.4 (7–465) days after starting study drug. Most acne occurred on the face; inflammatory papules were the most common morphology. Risk factors for acne included relevant concomitant medications (e.g., corticosteroids) started before acne onset and family and personal history of acne. Acne was generally managed with topical treatments. Conclusion: Mild or moderate acne reported in Japanese patients with AD receiving upadacitinib occurred in a dose-dependent manner and had a variable onset time. Acne was readily managed with topical treatments. Patients and clinicians should be aware of the risk of acne associated with upadacitinib treatment for AD. Trial Registration: ClinicalTrials.gov identifier, NCT03661138. [ABSTRACT FROM AUTHOR]

It is generally agreed that one origin of machine bias is resulting from characteristics within the dataset on which the algorithms are trained, i.e., the data does not warrant a generalized inference. We, however, hypothesize that a different 'mechanism' may also be responsible for machine bias, namely that biases may originate from (i) the programmers' cultural background, including education or line of work, or (ii) the contextual programming environment, including software requirements or developer tools. Combining an experimental and comparative design, we study the effects of cultural and contextual metaphors, and test whether each of these are 'transferred' from the programmer to the program, thus constituting a machine bias. Our results show that (i) cultural metaphors influence the programmer's choices and (ii) contextual metaphors induced through priming can be used to moderate or exacerbate the effects of the cultural metaphors. Our studies are purposely performed with users of varying educational backgrounds and programming skills stretching from novice to proficient. [ABSTRACT FROM AUTHOR]

Introduction: Renal colic is one of the most common urological emergencies, and is usually caused by ureteral colic spasms. Pain management in renal colic remains the central focus of emergency treatment. The purpose of this meta-analysis is to identify the efficacy and safety of ketamine versus opioids in the treatment of patients with renal colic. Methods: We searched PubMed, EMBASE, Cochrane Library, and Web of Science databases for published randomized controlled trials (RCTs) that referred to the use of ketamine and opioids for patients with renal colic. The methodology was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The mean difference (MD) or odds ratio (OR) with a 95% confidence interval (CI) was used to analyze the data. The results were pooled using a fixed-effects model or random-effects model. The primary outcome measure was patient-reported pain scores 5, 15, 30, and 60 min after drug administration. The secondary outcome measure was side effects. Results: The data analysis revealed that ketamine was similar to opioids in pain intensity at the time of 5 min post-dose (MD = − 0.40, 95% CI − 1.82 to 1.01, P = 0.57), 15 min post-dose (MD = − 0.15, 95% CI − 0.82 to 0.52, P = 0.67), 30 min post-dose (MD = 0.38, 95% CI − 0.25 to 1.01, P = 0.24). Also, the pain score of ketamine was better than that of opioids at 60 min after administration (MD = − 0.12, 95% CI − 0.22 to − 0.02, P = 0.02). As for safety, the ketamine group was linked to a significant decrease in the incidence of hypotensive (OR = 0.08, 95% CI 0.01–0.65, P = 0.02). The two groups did not statistically differ in the incidence of nausea, vomiting, and dizziness. Conclusions: Compared with opioids, ketamine showed a longer duration of analgesia in renal colic, with satisfactory safety. Trial Registration: The PROSPERO registration number is CRD42022355246. [ABSTRACT FROM AUTHOR]

Introduction: Spondyloarthritis (SpA) is a serious chronic inflammatory rheumatism implying different painful and crippling symptoms that require a multidisciplinary approach for the patient. Fatigue is one of the less well treated symptoms, even if its repercussion on everyday life is noticeable. Shiatsu is a Japanese preventive and well-being therapy that aims to promote better health. However, the effectiveness of shiatsu in SpA-associated fatigue has never been studied yet in a randomized study. Methods and Analysis: We describe the design of SFASPA (Etude pilote randomisée en cross-over évaluant l'efficacité du Shiatsu sur la FAtigue des patients atteints de SPondyloarthrite Axiale), a single-center, randomized controlled cross-over trial with allocation of patients according to a ratio (1:1) evaluating the effectiveness of shiatsu in SpA-associated fatigue. The sponsor is the Regional Hospital of Orleans, France. The two groups of 60 patients each will receive three "active" shiatsu and three sham shiatsu treatments (120 patients, 720 shiatsu). The wash-out period between the active and the sham shiatsu treatments is 4 months. Planned Outcomes: The primary outcome is the percentage of patients responding to the FACIT-fatigue score. A response to fatigue is defined as an improvement, i.e., an increase of ≥ 4 points in the FACIT-fatigue score, which corresponds to the "minimum clinically important difference" (MCID). Differences in the evolution of activity and impact of the SpA will be assessed on several secondary outcomes. An important aim of this study is also to gather material for further trials with higher proof of evidence. Trial Registration: NCT05433168, date of registration, June 21st, 2022 (clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Purpose: We aimed to demonstrate non-inferiority in terms of functional outcomes in patients with lumbar spinal stenosis who underwent full-endoscopic decompression compared with tubular-based microscopic decompression. Methods: This prospective, randomized controlled, non-inferiority trial included 60 patients with single-level lumbar spinal stenosis who required decompression surgery. The patients were randomly assigned in a 1:1 ratio to the full-endoscopic group (FE group) or the tubular-based microscopic group (TM group). Based on intention-to-treat analysis, the primary outcome was the Oswestry Disability Index score at 24 months postoperative. The secondary outcomes included the visual analog scale (VAS) score for back and leg pain, European Quality of Life-5 Dimensions (EQ-5D) score, walking time, and patient satisfaction rate according to the modified MacNab criteria. Surgery-related outcomes were also analyzed. Results: Of the total patients, 92% (n = 55) completed a 24-month follow-up. The primary outcomes were comparable between the two groups (p = 0.748). However, the FE group showed a statistically significant improvement in the mean VAS score for back pain at day 1 and at 6, 12, and 24 months after surgery (p < 0.05). No significant difference was observed in the VAS score for leg pain, EQ-5D score, or walking time (p > 0.05). Regarding the modified MacNab criteria, 86.7% of patients in the FE group and 83.3% in the TM group had excellent or good results at 24 months after surgery (p = 0.261). Despite the similar results in surgery-related outcomes, including operative time, radiation exposure, revision rate, and complication rate, between the two groups (p > 0.05), less blood loss and shorter length of hospital stay were observed in the FE group (p ≤ 0.001 and 0.011, respectively). Conclusion: This study suggests that full-endoscopic decompression is an alternative treatment for patients with lumbar spinal stenosis because it provides non-inferior clinical efficacy and safety compared with tubular-based microscopic surgery. In addition, it offers advantages in terms of less invasive surgery. Trial registration number (TRN): TCTR20191217001. [ABSTRACT FROM AUTHOR]

The complex set of challenges that middle-aged adults encounter emphasizes a need for mental health interventions that promote resilience and positive outcomes. The present study evaluated whether an online, self-guided social intelligence training (SIT) program (8 h) improved midlife adults' daily well-being and emotion regulation in the context of their own naturalistic everyday environment. A randomized controlled trial was conducted with 230 midlife adults allocated into either a SIT program or an attentional control (AC) condition that focused on healthy lifestyle education. Intent-to-treat analyses examined two bursts of 14-day daily surveys that participants completed pre- and post-treatment. Multilevel models evaluated pre-to post-treatment changes in mean positive and negative affect, as well as daily emotional reactivity to stressors and responsiveness to uplifts. Compared to the AC group, those in the SIT program reported improvements (i.e., decreases) in mean negative affect, positive emotional reactivity to daily stressors (i.e., smaller decreases in positive affect on stressor days), and negative emotional responsiveness to uplifts (i.e., lower negative affect on days without uplifts). Our discussion considers potential mechanisms underlying these improvements, highlights downstream effects on midlife functioning, and elaborates on how online delivery of the SIT program increases its potential for positive outcomes across adulthood. ClinicalTrials.gov Identifier: NCT03824353. [ABSTRACT FROM AUTHOR]

Introduction: Many Indians are at high risk of type 2 diabetes mellitus (T2DM). The blood glucose level can be improved through a healthy lifestyle (such as physical activity and a healthy diet). Yoga can help in T2DM prevention, being a culturally appropriate approach to improving lifestyle. We developed the Yoga Programme for T2DM Prevention (YOGA-DP), a 24-week structured lifestyle education and exercise (Yoga) program that included 27 group Yoga sessions and self-practice of Yoga at home. In this study, the feasibility of undertaking a definitive randomized controlled trial (RCT) was explored that will evaluate the intervention's effectiveness among high-risk individuals in India. Methods: A multicenter, two-arm, parallel-group, feasibility RCT was conducted in India. The outcome assessors and data analysts were blinded. Adults with a fasting blood glucose level of 100–125 mg/dL (i.e., at high risk of T2DM) were eligible. Participants were randomized centrally using a computer-generated randomization schedule. In the intervention group, participants received YOGA-DP. In the control group, participants received enhanced standard care. Results: In this feasibility trial, the recruitment of participants took 4 months (from May to September 2019). We screened 711 people and assessed 160 for eligibility. Sixty-five participants (33 in the intervention group and 32 in the control group) were randomized, and 57 (88%) participants were followed up for 6 months (32 in the intervention group and 25 in the control group). In the intervention group, the group Yoga sessions were continuously attended by 32 (97%) participants (median (interquartile range, IQR) number of sessions attended = 27 (3)). In the intervention group, Yoga was self-practiced at home by 30 (91%) participants (median (IQR) number of days per week and minutes per day self-practiced = 2 (2) and 35 (15), respectively). In the control group, one (3%) participant attended external Yoga sessions (on Pranayama) for 1 week during the feasibility trial period. There was no serious adverse event. Conclusions: The participant recruitment and follow-up and adherence to the intervention were promising in this feasibility study. In the control group, the potential contamination was low. Therefore, it should be feasible to undertake a definitive RCT in the future that will evaluate YOGA-DP's effectiveness among high-risk people in India. Feasibility Trial Registration: Clinical Trials Registry—India (CTRI) CTRI/2019/05/018893; registered on May 1, 2019. [ABSTRACT FROM AUTHOR]

Purpose: Although early palliative care is recommended, resource limitations prevent its routine implementation. We report on the preliminary findings of a mixed methods study involving a randomized controlled trial (RCT) of Symptom screening with Targeted Early Palliative care (STEP) and qualitative interviews. Methods: Adults with advanced solid tumors and an oncologist-estimated prognosis of 6–36 months were randomized to STEP or symptom screening alone. STEP involved symptom screening at each outpatient oncology visit; moderate to severe scores triggered an email to a palliative care nurse, who offered referral to in-person outpatient palliative care. Patient-reported outcomes of quality of life (FACT-G7; primary outcome), depression (PHQ-9), symptom control (ESAS-r-CS), and satisfaction with care (FAMCARE P-16) were measured at baseline and 2, 4, and 6 months. Semi-structured interviews were conducted with a subset of participants. Results: From Aug/2019 to Mar/2020 (trial halted due to COVID-19 pandemic), 69 participants were randomized to STEP (n = 33) or usual care (n = 36). At 6 months, 45% of STEP arm patients and 17% of screening alone participants had received palliative care (p = 0.009). Nonsignificant differences for all outcomes favored STEP: difference in change scores for FACT-G7 = 1.67 (95% CI: −1.43, 4.77); ESAS-r-CS = −5.51 (−14.29, 3.27); FAMCARE P-16 = 4.10 (−0.31, 8.51); PHQ-9 = −2.41 (−5.02, 0.20). Sixteen patients completed qualitative interviews, describing symptom screening as helpful to initiate communication; triggered referral as initially jarring but ultimately beneficial; and referral to palliative care as timely. Conclusion: Despite lack of power for this halted trial, preliminary results favored STEP and qualitative results demonstrated acceptability. Findings will inform an RCT of combined in-person and virtual STEP. [ABSTRACT FROM AUTHOR]

Purpose: The efficacy of sleep extension therapy using a remote support system (SET-R) was investigated in university students with increased social jetlag (SJL). Methods: For this two-arm parallel randomized controlled trial, we recruited Japanese university students with SJL ≥ 60 min. The SET-R provided an individualized sleep schedule for gradual sleep extension using email and sleep hygiene education, stimulus control therapy, and progressive muscle relaxation as web content. The control group was sent an email that encouraged them to record their sleep. The duration of the intervention program was two weeks. The primary outcome was the mean change in SJL two weeks later, assessed using the Munich ChronoType Questionnaire (MCTQ). The other outcomes included Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale (ESS), Insomnia Severity Index, Patient Health Questionnaire-9 (PHQ-9), and sleep quiz. A follow-up survey was conducted 6 months after the intervention. Results: Of 54 students, 26 were assigned to an intervention group and 28 to a control group. The difference in the mean change in SJL between the two groups (n = 26, n = 27) at two weeks was statistically significant (27.7 min, P = 0.048). The scores for the ESS, PHQ-9, and sleep quiz were improved in the intervention group relative to the control group. At the 6-month follow-up point, the difference in the mean change in SJL between the two groups (n = 22, n = 27) was not statistically significant, but scores for the PHQ-9, and sleep quiz remained significant. Conclusions: This study demonstrated the efficacy of the SET-R among university students with increased SJL. Trial Registration: The study was registered with the UMIN Clinical Trials Registry (UMIN000042634, 2021/02/01). [ABSTRACT FROM AUTHOR]

CO2 laser has been proposed as a treatment strategy for genitourinary syndrome of menopause (GSM). In order to assess its efficacy for treating GSM, we conducted a systematic review and meta-analysis. To identify the current state of randomized controlled trials on CO2 laser therapy for GSM, a literature review was conducted. We systematically searched the following databases: PUBMED, EMBASE and the Cochrane Controlled Trials Register. In addition, a review of the references in the retrieved studies was carried out. Of 562 identified studies, 9 were eligible and were included in our analysis, involving 523 patients in total. Based on our analysis, CO2 laser has no statistical difference compared with estrogen in VHI (p = 0.87), FSFI total score (p = 0.19), FSFI-Arousal (p = 0.11), FSFI-Desire (p = 0.72), FSFI-Orgasm (p = 0.45) and FSFI-Satisfaction (p = 0.08). The meta-analysis also showed that CO2 laser significantly improved FSFI-Lubrication scores compared with estrogen therapy (p = 0.0004). Furthermore, compared with the sham group, CO2 laser group had statistically improved VHI scores (p = 0.003) and FSFI scores (p < 0.00001). CO2 laser therapy may be an effective alternative to estrogen therapy for GSM both in cases where estrogen is not applicable because of comorbidities and in cases in which women do not desire to take estrogen. [ABSTRACT FROM AUTHOR]

Purpose: To test the hypothesis that daily supplementation with low-dose B vitamins plus betaine could significantly reduce plasma homocysteine concentrations in Chinese adults with hyperhomocysteinemia and free from background mandatory folic acid fortification. Methods: One hundred apparently healthy adults aged 18–65 years with hyperhomocysteinemia were recruited in South China from July 2019 to June 2021. They were randomly assigned to either the supplement group (daily supplementation: 400 μg folic acid, 8 mg vitamin B6, 6.4 μg vitamin B12 and 1 g betaine) or the placebo group for 12 weeks. Fasting venous blood was collected at baseline, week 4 and week 12 to determine the concentrations of homocysteine, folate, vitamin B12 and betaine. Generalized estimation equations were used for statistical analysis. Results: Statistically significant increments in blood concentrations of folate, vitamin B12 and betaine after the intervention in the supplement group indicated good participant compliance. At baseline, there were no significant differences in plasma homocysteine concentration between the two groups (P = 0.265). After 12-week supplementation, compared with the placebo group, there was a significant reduction in plasma homocysteine concentrations in the supplement group (mean group difference − 3.87; covariate-adjusted P = 0.012; reduction rate 10.1%; covariate-adjusted P < 0.001). In the supplement group, the decreased concentration of plasma homocysteine was associated with increments of blood concentrations of both folate (β = –1.680, P = 0.004) and betaine (β = –1.421, P = 0.020) after 12 weeks of supplementation. Conclusions: Daily supplementation with low-dose B vitamins plus betaine for 12 weeks effectively decreased plasma homocysteine concentrations in Chinese adults with hyperhomocysteinemia. Trial registration: This trial was registered at clinicaltrials.gov as NCT03720249 on October 25, 2018. Website:https://clinicaltrials.gov/ct2/show/NCT03720249. [ABSTRACT FROM AUTHOR]

Objective: The aim of this double-blind, randomized trial was to evaluate the influence of the occlusogingival distance (OGD) in noncarious cervical lesions (NCCLs) on the clinical performance of a regular bulk-fill resin composite and a regular nanofilled resin composite. Materials and methods: One hundred and forty NCCLs in 77 participants were randomly divided into four groups (n = 35), according to OGD (1.5 mm ± 10% or 3 mm ± 10%) and resin composites (Filtek Bulk Fill Posterior [B] or Filtek Z350 XT [C]), namely: 1.5 mm-B, 1.5 mm-C, 3 mm-B, and 3 mm-C. The restorations were bonded using a two-step self-etch adhesive (Clearfil SE Bond), applied following the manufacturer's instructions. Restorations were polished 1 week after placement. Two experienced and calibrated examiners evaluated the restorations using modified US Public Health Service criteria at baseline (7 days) and after 6, 12, 18, 24, and 30 months. Statistical analyses were carried out using Kruskal–Wallis, Friedman's repeated measures analysis of variance, and the Wilcoxon signed rank test (α = 0.05). Results: After 30 months, the recall rate was 94.2%. Eight restorations were lost (3 for 1.5 mm-C, 2 for 1.5 mm-B, 1 for 3 mm-C, and 2 for 3 mm-B). All groups resulted in a significantly worse marginal discoloration and surface texture at 30 months in comparison with the baseline (1 week). No significant difference was found for the other parameters. Conclusion: The restorations performed with both resin composites produced clinically acceptable restorations. The OGD of NCCLs did not influence the clinical performance of restorations. Clinical significance: The OGD of NCCLs did not have a significant effect on the clinical performance of a regular bulk-fill and nanofilled restorations. Both materials showed a very good performance on 30-month evaluation. [ABSTRACT FROM AUTHOR]

Objective: This study evaluated the effect of the supplementary use of the XP-endo Finisher on postoperative endodontic pain. Methods: This study was a randomized clinical trial with a parallel design. Ninety-two posterior teeth with necrotic pulps and apical periodontitis were instrumented with a single file (Reciproc) in a reciprocating movement followed or not (control) by additional instrumentation with XP-endo Finisher. Postoperative pain was assessed 24 h, 48 h, 72 h, and 7 days after the endodontic treatment (single session) using a universal pain assessment tool. The pain level was scored as absent, mild, moderate, or severe. The occurrence of sealer extrusion and flare-up was also recorded. Data on postoperative pain were analyzed through chi-square analysis, and the odds ratio was adjusted using a logistic regression model (α = 0.05). Results: Similar levels and risks of postoperative pain were observed for both interventions, regardless of the assessment time. Approximately half of the participants presented any postoperative pain in the first 24 h after the endodontic treatment, and this occurrence reduced by less than 20% after 72 h. The extrusion of root filling material was observed in 36% of cases, and no participant presented flared-up. Conclusions: The supplementary use of the XP-endo Finisher file did not affect the incidence or level of postoperative pain reported after the endodontic treatment of posterior teeth with periapical lesions. Clinical relevance: The supplementary use of the XP-endo Finisher did not affect postoperative pain following the endodontic treatment of posterior teeth using a single-file reciprocating system. Clinical trial registration: The study protocol was registered in the Brazilian Clinical Trials Registry under identification number RBR-76w7cj (June 19, 2018). [ABSTRACT FROM AUTHOR]

Purpose: Heat shock proteins (HSP-27) are reported to be involved in the pathophysiology of diabetes complications. The purpose of the current study is to assess the effects of eicosapentaenoic acid (EPA) supplementation on serum HSP-27, glycemic status and anthropometric indices in type 2 diabetes mellitus (T2DM) patients. Methods: Thirty-six patients with T2DM were randomly allocated to obtain 2 g per day EPA (n = 18) or placebo (n = 18) for 8 weeks in a randomized, double-blind, placebo-controlled clinical trial. Fasting serum levels of HSP 27, fasting blood sugar, hemoglobin A1C, as well as anthropometric indices were measured. Results: EPA supplementation reduces the serum level of HSP 27 in the EPA group compared with the placebo (P < 0.03). Although waist circumference (WC) decreased significantly in the EPA group at the end of the trial (P < 0.02), there was no significant difference in weight, WC, body mass index (BMI), and glycemic markers in both groups after intervention (P > 0.05). Conclusions: We found that EPA supplementation reduces HSP 27 serum level in T2DM patients. However, future large-scale trials are needed. [ABSTRACT FROM AUTHOR]

This was a randomized controlled trial, conducted to determine the effectiveness of CBT for depression delivered by trained therapists with an adapted Bengali CBT (BaCBT) manual, as compared to a control group. A total of 148 patients with a diagnosis of depression and attending psychiatry departments of three hospitals in Dhaka, Bangladesh, were assessed for eligibility, and 107 were randomly allocated to either treatment (n = 54) or a waitlist (n = 53). Assessments of outcome were completed at 3 time points (pre-test, post-test, and 1-month follow-up). The results revealed significant reductions in depression severity, anxiety, perceived stress, and suicidal ideation in the group that received the intervention, but modest to no significant changes in the control group. This is the first report of the results of an adapted CBT program for depression from Bangladesh. Although several limitations of the study are noted, and further studies are needed to generalize these current results, they indicate that CBT is an efficacious treatment option for depression in varied cultures. [ABSTRACT FROM AUTHOR]

Cyclical mastalgia of moderate to severe degree requires systemic drug therapy. Tamoxifen is the drug of choice worldwide. A novel molecule, centchroman/Ormeloxifene, developed in India, was found to be equally effective in previous studies. However, its optimal dose regimen is uncertain. We conducted three-arm randomized controlled trial to compare the effectiveness in relieving breast pain. Group 1 received tamoxifen 10 mg daily, and groups 2 and 3 received centchroman 30 mg twice and 30 mg thrice a week, respectively, for 3 months with a follow-up of 3 more months. Breast pain score, nodularity score, sonographic evaluation of the breasts and ovaries, quality of life scores, and adverse events were recorded. The number of patients enrolled was 32, 31, and 30 in group 1, group 2, and group 3, respectively. All three groups had significant improvement in breast pain scores [group 1 (5 → 2), group 2 (5 → 2), group 3 (6 → 2), p < 0.001)], nodularity scores [group1 (1 → 0), group 2 (1 → 0), group 3 (1 → 0), p < 0.001)] and in the quality of life scores over time. However, no significant differences were observed in-between the groups. Transient ovarian cyst formation and menstrual irregularities were more common with a higher dose of centchroman. Centchroman in the dosages of 30 mg twice or thrice a week is as effective as a daily dose of tamoxifen 10 mg in relieving pain, nodularity, and improving quality of life scores. The dose of centchroman 30 mg twice a week for 12 weeks has the least adverse effects and should be accepted as the optimal dosage regimen. There is a need of further study with a greater number of participants and longer follow-up. Trial registration number: CTRI/2018/02/012043 (Registered on: 21/02/2018). [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate changes in sedentary and active behaviors when previously inactive adults start exercising in the morning or evening. One-hundred adults with overweight or obesity (BMI ≥ 25 kg/m2) were recruited for a 12-week intervention and randomized to one of three groups: (i) morning exercise (AMEx; 0600–0900); (ii) evening exercise (PMEx; 1600–1900); or (iii) waitlist control. AMEx and PMEx were prescribed self-paced aerobic exercise to achieve a weekly total of 250 min via a combination of supervised and unsupervised training. Sedentary and active behavior times were measured at baseline, mid- and post-intervention using the multimedia activity recall for children and adults. Time spent engaging in physical activity was significantly increased from baseline at both mid- (+ 14–22 min·day−1) and post-intervention (+ 12–19 min·day−1), for AMEx and PMEx. At 12-weeks, participants in both morning and evening exercise groups reported increased time spent Sleeping (+ 36 and + 20 min·day−1, respecitively), and reduced time spent watching TV/playing videogames (− 32 and − 25 min·day−1, respectively). In response to an exercise stimulus, previously inactive adults make encouraging modifications in how they use their time, and the patterns of change are similar with morning and evening exercise. [ABSTRACT FROM AUTHOR]

Methamphetamine (MA) is a widely abused illegal drug. As no medication is available for MA addiction, new treatment options are needed. This study examined the effects of aerobic exercise (AE) and attentional bias training (ABT), alone and in combination, on cognitive function and psychiatric symptoms in individuals with MA dependency. One hundred individuals with MA dependency were randomly divided into four groups of 25 persons each (AE + ABT, AE, ABT, and control group). The AE intervention was conducted five times per week for 8 weeks, while the ABT intervention was conducted once per week for 8 weeks. Multiple indicators of cognitive function and psychiatric symptoms revealed significant time-group interactions [F(1,87) = 2.580–4.143, p =.009–.049, η2 =.083–.170]. AE, but not ABT, benefited individuals with MA dependency. Combined AE and ABT was more effective than ABT alone, but not as effective as AE alone. [ABSTRACT FROM AUTHOR]

Purpose : Although mobile-based symptom monitoring is expected to improve patient participation in symptom management during anticancer therapy, previous trials have not evaluated its effectiveness. Therefore, this study aims to evaluate the impact of a symptom monitoring mobile application on improving patient participation in symptom management during anticancer therapy. Methods: We conducted a single-center, open-label, randomized controlled trial that enrolled patients with breast, lung, head and neck, esophageal, or gynecologic cancer who were scheduled to receive anticancer therapy (oral or intravenous) between October 2020 and March 2021. We excluded patients with physical or psychological problems. The intervention group received a symptom monitoring application for 8 weeks, and the control group received the usual clinical practice. At 8 weeks, the improvement in patient participation in symptom management was assessed, and additionally quality of life and unplanned clinical visits were assessed. Results: A total of 222 patients were included in the analysis, of whom 142 were randomly assigned to the intervention group and 71 to the control group. The intervention group reported better outcome in patient participation in symptom management than the control group at 8 weeks (mean scores of 8.5 vs. 8.0; P = 0.01). There were no significant differences between the groups in Quality of life (P = 0.88) and unplanned clinical visits (P = 0.39–0.76). Conclusions: This study is meaningful in figuring out that the mobile-based symptom monitoring made them more engaged in their management. Future research should continue to evaluate the effects of patient participation as mediators of clinical outcomes. Trial registration: ClinicalTrials.gov NCT04568278. [ABSTRACT FROM AUTHOR]

Background and Aims: Chromoendoscopy with Lugol's staining is used to screen for early esophageal squamous cell carcinoma (ESCC). Its efficacy is greatly limited by unstandardized defoaming preparation. This study aimed to confirm whether pre-procedure oral administration of pronase could improve the diagnostic performance of Lugol chromoendoscopy in high-risk patients being screened for early ESCC. Methods: A total of 955 patients at-risk were prospectively recruited for screening for ESCC. Patients were randomly assigned (1:1) to groups with or without (control group) pronase administration. Endoscopic diagnosis of early ESCC was based on the presence of pink-color sign in Lugol's unstained area, and a biopsy was routinely conducted if the Lugol's unstained lesion was larger than 0.5 cm. The early cancer detection rate was used as the primary endpoint. Results: Pre-procedure oral administration of pronase improved mucosal visibility during Lugol chromoendoscopy (P = 0.008). There were no differences in the number of Lugol's unstained lesions between the 2 groups (23.27% [111/477] vs. 25.11% [120/478], P = 0.508). Meaningfully, the detection rate of ESCC (confirmed by histopathology) was significantly higher in the pronase group than in the control group (27.03% [30/111] vs. 17.50% [21/120], P = 0.041), as well as the detection rate of lesions with pink-color sign during chromoendoscopy (35.14% [39/111] vs. 13.33% [16/120], P < 0.001). The diagnostic performance of Lugol chromoendoscopy had improved with the use of pronase (area under the curve = 0.85 vs. 0.69, P = 0.019), accompanied by an increased sensitivity (86.67% vs. 47.62%, P = 0.004). There was no difference in the adverse events between the 2 groups (P = 0.793). Conclusions: Pre-procedure oral administration of pronase significantly increased the detection rate of early ESCC and optimized the diagnostic performance of Lugol chromoendoscopy, which should be recommended during routine endoscopic screening for early ESCC in high-risk patients. Trial registration: Pronase improves efficacy of Lugol chromoendoscopy screening on esophageal cancerous lesions (NCT02030769). [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study is to evaluate the longevity of two fiber post cementation strategies in a prospective, multicenter, non-inferiority, double-blind randomized controlled trial. Methods: A total of 152 teeth, with adequate endodontic treatment and loss of coronal structure and bilateral simultaneous posterior occlusal contacts, were randomly allocated to receive glass fiber posts cemented with a conventional cementation strategy (CRC group: adhesive system + resin cement) (Adper Single Bond + RelyX ARC; 3 M-ESPE) or a self-adhesive cementation strategy (SRC group: self-adhesive resin cement; RelyX U100/U200; 3 M-ESPE). The patients were recalled annually for clinical and radiographical evaluation with a 93% recall rate (142 teeth, with 74 at CR groups and 68 at SRC group). The primary outcome was survival rate, considering the fiber post debonding (loss of retention). The secondary outcome included the success rate of the prosthetic treatment with crown debonding, post fracture, and tooth loss (not related to post failure). Both outcomes were evaluated annually. The Kaplan–Meier method and Cox regression with 95% confidence interval were used for the statistical analysis. Results: For the primary outcome (failures directly related to fiber posts cementation strategy), there were 4 fiber post debondings (2 per group), 8 root fractures (3 for SRC group and 5 for CRC group), and one mixed failure (debonding combined with root fracture for CRC), with both strategies presenting similar survival rates (p = 0.331), with 88.9% for the CRC group and 90.9% for the SRC group. For the secondary outcome (failures not related to fiber post cementation strategies), there were 8 crown debondings, 3 post fractures, and 3 tooth losses, with no statistically difference between groups (p = 0.701), with 77% for SRC and 82% for CRC. Conclusion: Fiber post cementation strategies with conventional or self-adhesive resin cement presents similar tooth survival and success rates. Trial registration: NCT01461239 Clinical relevance: Both adhesive cementation strategies led to high survival and success rates and are indicated for fiber post cementation, even after a long follow-up period (up to 106 months). [ABSTRACT FROM AUTHOR]

Objectives: To assess the clinical efficacy of xenogeneic collagen matrix (XCM) plus apically positioned flap (APF) in augmenting the keratinized mucosa (KM) width (KMW) and thickness (KMT) around posterior mandibular implants and compare it with free gingival graft (FGG) plus APF. Material and methods: Thirty patients with KMW ≤ 2 mm in the posterior mandibular implant site were randomly allocated to the FGG group (FGG plus APF) or the XCM group (XCM plus APF). Clinical assessments, including KMW and KMT, shrinkage rate of established KM, and peri-implant soft tissue health, were evaluated during a 6-month follow-up. Additionally, the esthetic outcomes and patient-reported postoperative morbidity were investigated. Results: At 6 months, the KMW measured 3.60 ± 0.79 mm in the FGG group and 3.28 ± 0.96 mm in the XCM group (p = 0.186). Both groups showed a tendency for graft contraction (FGG, 42.11%; XCM, 53.22%). The KMT measured 1.24 ± 0.34 mm in the FGG group and 0.95 ± 0.29 mm in the XCM group, with statistical difference (p = 0.002). No difference in the peri-implant soft tissue health was observed between the two groups (p > 0.05), but the esthetic outcomes were better in the XCM group (p < 0.05). Conclusions: XCM plus APF rendered a similar clinical efficacy in augmenting KMW as that with FGG plus APF, but with higher shrinkage. XCM plus APF was inferior with respect to FGG plus APF in augmenting KMT. The esthetic outcomes were better with XCM plus APF than FGG plus APF. Clinical relevance XCM plus APF graft was inferior with respect to FGG plus APF in augmenting KMT. Trial registration: Trial registration number: ChiCTR2200058027 and date: 03/27/2022. [ABSTRACT FROM AUTHOR]

Although parents of siblings play a crucial role in the development of both the positive and negative aspects of their children's relationships, relatively few parenting programs specifically target sibling conflict alongside sibling warmth. To bridge this gap, the current study reports the outcomes of a randomized controlled trial evaluating a brief parenting intervention focusing on improving sibling relationships. A total of 74 parents reporting concerns about sibling conflict were randomized to either the Triple P brief discussion group intervention condition (n = 37) or the waitlist control condition (n = 37). Parents were predominately Caucasian, female, from a middle-income background. Parents completed a range of self-report measures examining the quality of the sibling relationship, parenting practices, family functioning, and child emotional and behavioral problems. Across treatment groups, participants showed improvements on almost all measures of sibling conflict, sibling warmth, child emotional and behavioral problems, parenting practices, and parenting confidence. Participants in the treatment group also experienced a greater reduction in the amount of help they wanted to manage sibling warmth, relative to participants in the control group. These results suggest that a low-intensity parenting intervention may only have a small effect on improving sibling relationships. Additional research is needed to determine how to broaden program efficacy for sibling conflict and parental adjustment, for families from diverse levels of income and family composition. Trial registration: ANZCTR 365567. Highlights: Sibling relationships that are more strongly positive than negative may support child, parent and family wellbeing. To date, no evidence-based parenting program has promoted positive sibling relationships while decreasing sibling conflict. A brief discussion group was developed within the Triple P system to target warmth and agonism in sibling relationships. A randomized control trial revealed an improvement in parent-reported warmth in the sibling relationship, but not agonism. Intervention effectiveness may be further explored with more diverse samples and multi-informant measures. [ABSTRACT FROM AUTHOR]

Background: Obtaining comprehensive family health history (FHH) to inform colorectal cancer (CRC) risk management in primary care settings is challenging. Objective: To examine the effectiveness of a patient-facing FHH platform to identify and manage patients at increased CRC risk. Design: Two-site, two-arm, cluster-randomized, implementation-effectiveness trial with primary care providers (PCPs) randomized to immediate intervention versus wait-list control. Participants: PCPs treating patients at least one half-day per week; patients aged 40–64 with no medical conditions that increased CRC risk. Interventions: Immediate-arm patients entered their FHH into a web-based platform that provided risk assessment and guideline-driven decision support; wait-list control patients did so 12 months later. Main Measures: McNemar's test examined differences between the platform and electronic medical record (EMR) in rates of increased risk documentation. General estimating equations using logistic regression models compared arms in risk-concordant provider actions and patient screening test completion. Referral for genetic consultation was analyzed descriptively. Key Results: Seventeen PCPs were randomized to each arm. Patients (n = 252 immediate, n = 253 control) averaged 51.4 (SD = 7.2) years, with 83% assigned male at birth, 58% White persons, and 33% Black persons. The percentage of patients identified as increased risk for CRC was greater with the platform (9.9%) versus EMR (5.2%), difference = 4.8% (95% CI: 2.6%, 6.9%), p <.0001. There was no difference in PCP risk-concordant action [odds ratio (OR) = 0.7, 95% CI (0.4, 1.2; p = 0.16)]. Among 177 patients with a risk-concordant screening test ordered, there was no difference in test completion, OR = 0.8 [0.5,1.3]; p = 0.36. Of 50 patients identified by the platform as increased risk, 78.6% immediate and 68.2% control patients received a recommendation for genetic consultation, of which only one in each arm had a referral placed. Conclusions: FHH tools could accurately assess and document the clinical needs of patients at increased risk for CRC. Barriers to acting on those recommendations warrant further exploration. Trial Registration Number: ClinicalTrials.gov NCT02247336 https://clinicaltrials.gov/ct2/show/NCT02247336 [ABSTRACT FROM AUTHOR]

Suicide prevention videos featuring young people's personal narratives of hope and recovery are increasingly used in suicide prevention, but research on their effects is scarce. A double-blind randomized controlled trial was conducted to test the effects of a suicide prevention video featuring an adolescent mastering his suicidal ideation by getting help on 14 to 19-year-olds. N = 299 adolescents were randomly allocated to watch the intervention video (n = 148) or a control video unrelated to mental health (n = 151). Questionnaire data were collected before (T1) and immediately after exposure (T2), and 4 weeks later (T3). Data were analyzed with a repeated-measures ANCOVA. The primary outcome was suicidal ideation, assessed with the Reasons for Living Inventory for Adolescents. Secondary outcomes were help-seeking intentions, attitudes towards suicide, stigmatization of suicidality, and mood. There was an immediate beneficial effect of the intervention on suicidal ideation (T2 mean change from baseline within intervention group MChange = − 0.16 [95% CI − 0.20 to − 0.12], mean difference compared to control group MDiff = − 0.09 [95% CI − 0.15 to − 0.03], ηp2 = 0.03), which was not maintained at T3. Participants reported significantly higher help-seeking intentions, which was maintained at 4-week follow-up. They also reported a sustained reduction of favorable attitudes to suicide. Effects on suicidal ideation were mediated by identification with the featured protagonist. Adolescents appear to benefit from suicide prevention narratives featuring personal stories from peers on coping with suicidal ideation and help-seeking. Trial registration DRKS00017405; 24/09/19; retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: The need of ureteric access sheath (UAS) in retrograde intrarenal surgery (RIRS) has been controversial for gaining high success in terms of stone free rate (SFR), reducing operative times and complications. There has been lack of high level of evidence in the literature on this topic. Materials and methods: This prospective randomized controlled trial (RCT) was conducted in the Department of Urology, PGIMER, Chandigarh from July 2019 to Dec 2021. The effect of UAS on the outcome of RIRS (SFR, operative time and complications) for renal stone disease was assessed. Ninety patients were randomized into two groups: 41 patients in Group 1 (RIRS with UAS) and 40 patients in Group 2(RIRS without UAS) were finally analyzed after exclusion. All the patients underwent preoperative double J stent placement at least 10 days prior to the definitive procedure. Operative time was recorded and postoperative pain was assessed by visual analogue scale(VAS) at 6 and 24 h postoperatively. Complications and emergency visits were recorded up to one month post procedure. SFR was assessed at 1 month using noncontrast CT KUB. Success was defined as absence of any residual fragment more than 3 mm in maximum diameter. Results: Demographic parameters (age, body mass index, and comorbidities) and preoperative parameters (stone burden, proportion of recurrent stone formers and proportion of patients with inferior calyceal stones) were comparable between the two groups. Operative times (45.49 vs 48.38 min; p − 0.484) and VAS scores at 6 and 24 h post-op (p − 0.577) were also comparable between Group 1 and Group 2. SFR was comparable in Group 1 and Group 2 (78.05% vs 80%, p − 0.829). Postoperative complications were higher in the UAS group, but not statistically significant (4.88% vs 0%; p − 0.157). Conclusion: The use of UAS during RIRS is not associated with improved SFR. RIRS can be performed safely without the use of UAS and without increasing postoperative complications. [ABSTRACT FROM AUTHOR]

Objectives: Stability values of mini-implants (MIs) are ambiguous. Survival data for MIs as supplementary abutments in reduced dentitions are not available. The aim of this explorative research was to estimate the 3-year stability and survival of strategic MIs after immediate and delayed loading by existing removable partial dentures (RPDs). Material and methods: In a university and three dental practices, patients with unfavorable tooth distributions received supplementary MIs with diameters of 1.8, 2.1, and 2.4 mm. The participants were randomly allocated to group A (if the insertion torque ≥ 35 Ncm: immediate loading by housings; otherwise, immediate loading by RPD soft relining was performed) or delayed loading group B. Periotest values (PTVs) and resonance frequency analysis (RFA) values were longitudinally compared using mixed models. Results: A total of 112 maxillary and 120 mandibular MIs were placed under 79 RPDs (31 maxillae). The 1st and 3rd quartile of the PTVs ranged between 1.7 and 7.8, and the RFA values ranged between 30 and 46 with nonrelevant group differences. The 3-year survival rates were 92% in group A versus 95% in group B and 99% in the mandible (one failure) versus 87% in the maxilla (eleven failures among four participants). Conclusions: Within the limitations of explorative analyses, there were no relevant differences between immediate and delayed loading regarding survival or stability of strategic MIs. Clinical relevance: The stability values for MIs are lower than for conventional implants. The MI failure rate in the maxilla is higher than in the mandible with cluster failure participants. Clinical trial registration: German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS-ID: DRKS00007589, www.germanctr.de), January 15, 2015. [ABSTRACT FROM AUTHOR]

Background: The current study's aim was to evaluate and compare demineralized freeze-dried bone allograft (DFDBA) with and without concentrated growth factor (CGF) membrane in the treatment of periodontal intrabony defects on both a clinical and radiographic level. Methods: 30 stage III grade B periodontitis patients with bilateral intrabony defects were involved in the split mouth randomized controlled trial, and they received either DFDBA alone (control group) or DFDBA plus CGF membrane treatment (test group). At baseline and 6 and 12 months, the gingival index (GI), plaque index (PI), probing pocket depth (PPD), clinical attachment level (CAL), and gingival recession (GR) were assessed, whereas cone beam computed tomography was used to assess the bone defect height (BDH), vertical bone loss (VBL), bone defect depth (BDD), mesio-distal bone defect width (MDBDW), bucco-lingual bone defect width (BLBDW), and bone defect volume (CBCT) at baseline and 12 months. Results: The radiographic measures BDH, BDD, MDBDW, BLBDW, and BDV in the test group likewise showed a higher reduction in PPD and gain in CAL than the control group. The results of the intergroup comparison showed that the test group had statistically significant differences in BDH, BDD, and MDBDW. Conclusion: The data show that the test group achieved better results, with greater reductions in PPD, gains in CAL, and decreases in BDH, BDD, MDBDW, BLBDW, and BDV. Clinical relevance: The use of concentrated growth factor in conjunction with demineralized freeze-dried bone allograft may be suggested for the treatment of periodontal intrabony defects. [ABSTRACT FROM AUTHOR]

Background: Unsightly opaque white impaired enamel may ruin a great aesthetic orthodontic outcome. This study aims to evaluate effectiveness of Clinpro Tooth Crème (0.21% w/w NaF anti-caries dentifrice with 950 ppm fluoride and f-TCP) and MI Varnish with RECALDENT™ (CPP-ACP) for treatment of white spot lesions (WSLs). Materials and methods: This was a randomized (1:1:1), single-blind, 3-armed, active-controlled, parallel-group trial. The study comprised three groups of 35 patients randomly assigned in blocks of 3 or 6 to one of the three following arms of the study- Group I: Clinpro™ Tooth Crème 0.21% Sodium Fluoride Anti-Cavity Paste with functional–Tri Calcium Phosphate(f-TCP) group. Group II: Fluoride varnish group (MI Varnish with RECALDENT™). Group III: Home-care group (control). For the subjective assessment, a blinded panel of 4 dental experts rated the improvement in WSLs over the eight weeks using a visual analog scale (VAS). Results: In total, 240 WSLs were identified, with maxillary lateral incisors and canines showing the highest incidence. Group I achieved the highest success rate of 67.61 (%) followed by group II (60.59%). There were no significant differences between the success rates of treatment in groups I and II. A minimum decline in WSLs was found in the control group, with a success rate of only 32.43%, significantly less than the first two groups (P <.001). Conclusion: Both the test agents in consideration were comparable in their remineralization potential. Clinpro Tooth Crème provides additional protection against decalcification of enamel compared to MI Varnish with RECALDENT™ (CPP-ACP). Trial/project registration no. and date: 4857/2017 on 21 June 2017. [ABSTRACT FROM AUTHOR]

To overcome interruption of skin barrier in transdermal drug delivery, the microneedle (MN) patch penetrates the barrier by punching with its MNs. Setting a needleless patch (NL patch) as the control intervention, this study assessed the efficacy of a biodegradable hyaluronic acid MN patch (BHMN patch) for atopic dermatitis (AD) patients with dry skin. Similar two AD lesions were selected from the extremities of a participant. For one lesion, a BHMN patch was attached for 6–8 h on where an aroma cream was applied (BHMN patch group). Simultaneously, an NL patch was attached on the other lesion as in the BHMN patch group (NL patch group). For 2 weeks, the interventions were conducted 3 times a week. The local scoring AD (L-SCORAD) index, the visual analog scale for pruritus and skin dryness, skin hydration, the transepidermal water loss (TEWL), and safety were assessed. Fifteen participants finished this trial with no dropouts. Both groups improved the L-SCORAD index after 2 weeks (p < 0.05), but the score of the BHMN patch group decreased more than that of the NL patch group (p < 0.05). The other outcomes, except for the TEWL, also showed statistical significance in intragroup comparisons. Nevertheless, none of the other outcomes showed statistical significance in intergroup comparisons. The TEWL showed no statistical significance even in intragroup comparison. Recoverable minor adverse events were reported in three cases. Considering the result of L-SCORAD index, the BHMN patch may be effective for ameliorating AD. However, a large-scale confirmatory trial is necessary to reassess other outcomes. Trial Registration: This study was registered with the Clinical Research Information Service, Republic of Korea (Submitted date: 04/01/2022, Registered date: 23/02/2022, The first participant enrollment: 01/12/2021, Registration No. KCT0007037). [ABSTRACT FROM AUTHOR]

The exact aetiology of pityriasis lichenoides chronica (PLC) remains unknown. While phototherapy is the most investigated therapeutic modality, azithromycin has been used scarcely. The aim of this study is to evaluate the therapeutic efficacy of azithromycin in the treatment of PLC compared to NB-UVB and evaluating the presence of streptococcal infection as a possible etiological factor in PLC patients. The study was designed as a randomised controlled trial. Twenty-four patients with PLC were randomly allocated into either azithromycin (n = 13, standard dose every 10 days) or NB-UVB (n = 11, thrice weekly) groups. End of study (EOS) was either complete clearance of lesions or a maximum of 8 weeks. Therapeutic efficacy was defined as percent reduction in lesions and was calculated for the rash as a whole, erythematous papules alone, and hypopigmented lesions alone and graded into complete, very-good, good, poor or no response. Anti-streptolysin O titre (ASOT), anti-deoxyribonuclease B titre (anti-DNaseB) and throat culture were evaluated at day 0. No significant difference existed between both groups as regards therapeutic efficacy. At EOS, NB-UVB achieved significantly more percent reduction in the extent of hypopigmented lesions and consequently in the rash as a whole (p = 0.001, p = 0.034, respectively). The extent of the rash as a whole was significantly less in the NB-UVB at EOS (p = 0.029, respectively). The effect of NB-UVB on hypopigmented lesions appeared early at week 4 of treatment. Only two patients, one from each group, relapsed during the 3 month follow-up. Evidence of recent streptococcal infection was present in 79% of the cases, mainly in the form of elevated ASOT (94.7%). It was significantly more encountered in young children (< 13 years) (p = 0.03) and was associated with more extent of erythematous papules and consequently with more extent of the rash as a whole (p = 0.05 and p = 0.01, respectively). It did not affect outcome of therapy at EOS. Azithromycin did not show more favorable response in patients with recent streptococcal infection. Therapeutic efficacy of azithromycin is comparable to NB-UVB in treatment of PLC; however, NB-UVB is superior in management of hypopigmented lesions. It is highly suggested that PLC could be a post streptococcal immune mediated disorder. Registration number: ClinicalTrials.gov, NCT03831269. [ABSTRACT FROM AUTHOR]

Previous studies have shown that self-affirmation increases acceptance of a message and motivates health behavior change. The present study investigated whether self-affirmation increases the acceptance of persuasive messages on COVID-19 vaccines and promotes vaccination intention. A total of 144 participants were randomly assigned to the self-affirmation (n = 72) or control (n = 72) groups before reading a persuasive message on COVID-19 vaccines. The results revealed that the self-affirmation group showed significantly higher acceptance of persuasive information on COVID-19 vaccines than the control group. Additionally, the self-affirmation group also showed significantly higher post-experiment vaccination intention than the control group. Mediation analysis indicated that increased acceptance of persuasive information significantly mediated the beneficial effects of self-affirmation on post-experiment vaccination intention. The present study demonstrated that self-affirmation could be an effective strategy for increasing the acceptance of persuasive messages on COVID-19 vaccines and promoting vaccination intention. [ABSTRACT FROM AUTHOR]

Introduction: Nonsteroidal antiinflammatory drugs (NSAIDs) are commonly used for pain disorders such as low back pain and exist in multiple formulations; however, no systemically acting transdermal formulations are available for low back pain. Transdermal formulations can be safely administered even to patients with trouble swallowing or at risk of aspiration, and without regard to the effect of food on drug absorption. Unlike locally acting formulations, systemically acting transdermal formulations need not be applied at the target site, so dosing is simple and the burden is not on one area of the skin. A patch with the systemically acting NSAID diclofenac sodium is approved in Japan for treatment of cancer-related pain, and we hypothesized that it would be useful for controlling low back pain. Methods: This randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of diclofenac sodium patch in Japanese patients with low back pain. Eligible patients were randomized to receive diclofenac sodium patch 75 mg or 150 mg or placebo once daily for 2 weeks. The primary endpoint was pain intensity assessed on a visual analog scale (VAS). Results: Primary analysis of the primary endpoint showed that both doses of the diclofenac sodium patch (150 mg and 75 mg) were superior to placebo in terms of absolute change from baseline in mean 3-day VAS score after 2 weeks' treatment; the mean difference between the active and placebo treatments in this variable was −5.67 [95% confidence interval (CI) −9.34 to −2.00] mm in the 150 mg group and −5.68 (95% CI −9.34 to −2.01) mm in the 75 mg group. Most adverse events were mild. No serious adverse events occurred. Conclusion: In Japanese patients, diclofenac sodium patch is effective for the relief of low back pain and is well tolerated. Trial Registration: JPRN number, JPRN-JapicCTI-205134. [ABSTRACT FROM AUTHOR]

Objectives: Many patients experience anxiety during MRI examinations. However, little attention has been focused on decreasing patient anxiety and minimizing on-site cancellations. Here, we aimed to investigate the effects of aromatherapy and music therapy on alleviating anxiety during MRI examinations. Methods: This single-center, double-blinded, randomized control trial was conducted between November 1, 2021, and January 10, 2022. Patients undergoing MRI examinations were assigned randomly into either the aromatherapy group (AG), music therapy group (MG), aromatherapy plus music therapy group (AMTG), or routine care group (RG) at a ratio of 1:1:1:1. Aromatherapy was conducted through inhalation of lavender oil. Music therapy was performed using Pachelbel's Canon in D major. The primary outcome was the change in anxiety before and after the MRI scan, assessed using both the State–Trait Anxiety Inventory form 1 (STAI-1) and Self-Rating Anxiety Scale (SAS). The second outcome was the participant's comfort, measured using Kolcaba's General Comfort Questionnaire (GCQ). Results: A total of 200 participants (mean age: 48.3 ± 14.9 years; 126 [63.0%] females) were enrolled, with 50 per group. The mean anxiety scores of the AMTG showed greater reduction compared with the AG, MG, and RG (ΔSTAI-1: 6.5 vs 2.6 vs 2.7 vs 1.9, p < 0.001; ΔSAS: 4.0 vs 1.4 vs 1.7 vs 0.6, p < 0.001). The mean GCQ score of the AMTG was higher compared with the AG, MG, and RG (98.0 vs 92.6 vs 91.2 vs 89.2, respectively, p < 0.001). Conclusion: Aromatherapy combined with music therapy is effective for reducing patients' anxiety and improving their comfort level during MRI scans. Key Points: • In this randomized control trial of 200 participants undergoing MRI scans, aromatherapy plus music therapy is effective in reducing STAI-1 and SAS, as well as improving GCQ scores. • Although there was a significant difference between the aromatherapy plus music therapy and the single-intervention modalities, no significant differences were observed between the aromatherapy and music therapy themselves for state anxiety and comfort score. • Aromatherapy plus music therapy is a safe, non-invasive, nonpharmacological, and inexpensive patient-centered intervention for reducing anxiety and improving comfort in adults undergoing MRI examinations. [ABSTRACT FROM AUTHOR]

Purpose: Bicruciate-retaining (BCR) prostheses may improve satisfaction of patient undergoing total knee arthroplasty (TKA). The objective of this randomized controlled trial was to assess whether BCR prostheses provide better clinical outcomes than posterior-stabilized (PS) prostheses. Materials and methods: This is a randomized single-blind control trial involving a total of 77 patients with knee osteoarthritis, randomly assigned to undergo TKA with a BCR or PS implant between 2015 and 2019. Mean follow-up period was 39 months. Clinical and demographic data were extracted manually from medical records. Data acquisition included patient demographics, knee range of motion, and patient-reported outcomes via KSS, KOOS, WOMAC, and SF-12 scores. Results: A total of 38 patients were randomized to the PS group and 39 to the BCR group. At the 5-year follow-up, no statistical differences were noted for knee range of motion or patient-reported outcomes between the two groups, except for a greater knee flexion in the early follow-up period in the PS group. Five adverse events occurred in the BCR group compared to none in the PS group (p = 0.02). Conclusion: BCR TKA yield similar clinical and patient-reported outcomes 5 years following the intervention compared with PS TKA. The BCR TKA had more complications. Level of evidence: I (Randomized Controlled Trial). [ABSTRACT FROM AUTHOR]

Introduction: Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation. Methods: Globally, patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16, then bimekizumab 320 mg Q4W). Efficacy endpoints included week 16 Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) 0/1, and other outcomes [PASI 100, PASI 75, IGA 0, Dermatology Life Quality Index (DLQI) 0/1, absolute PASI, scalp IGA, Psoriasis Symptoms and Impacts Measure (P-SIM) responses]. Safety analyses were conducted. Results: There were 108 Japanese randomized patients (bimekizumab: 62; ustekinumab: 29; placebo: 17). At week 16, bimekizumab-treated patients had a higher clinical response versus ustekinumab and placebo (PASI 90: 85.5% versus 51.7% and 5.9%; IGA 0/1: 82.3% versus 48.3% and 0.0%). Over 52 weeks, improved clinical response was maintained with bimekizumab, including patients switching from placebo at week 16. Overall, the safety profile in Japanese patients was consistent with that observed in the global population. Conclusion: Bimekizumab resulted in improved clinical response versus ustekinumab and placebo, and was well-tolerated in Japanese patients. Trial registration: NCT03370133. [ABSTRACT FROM AUTHOR]

Introduction: Evidence on second-line agents for osteoporosis and osteopenia associated with glucocorticoid use after first-line bisphosphonate therapy is limited. We, therefore, examine the efficacy of denosumab on bisphosphonate-treated osteoporosis and osteopenia in Japanese systemic rheumatic disease (SRD) patients receiving glucocorticoids. Materials and methods: Glucocorticoid-treated SRD patients with a pre-existing fragility fracture, either lumbar spine (LS) or femoral neck (FN) bone mineral density (BMD) T-score of ≤ −2.5 or of ≤ −1.5 without a significant increase in BMD in the past year despite oral bisphosphonate therapy were enrolled in this study. They were randomized to switch to 60 mg subcutaneous denosumab every six months (switching group) or to continue the bisphosphonate (continuing group). The primary endpoint was the percent change from baseline in BMD at the LS and FN at week 52. Results: Of the 39 subjects, 19 were assigned to the switching group and 20 to the continuing group. The switching group showed significant increases in LS BMD (5.7% vs. 1.1%, p = 0.002) and FN BMD (4.2% vs. −0.3%, p = 0.008) at week 52 than the continuing group, with a significant decrease in serum tartrate-resistant acid phosphatase 5b (−28.1% vs. 7.0%, p < 0.001) and improved patient satisfaction. Conclusion: Switching to denosumab demonstrated greater efficacy than continuing bisphosphonates in increasing BMD, inhibiting osteoclast activation, and enhancing patient satisfaction in Japanese bisphosphonate-treated osteoporosis and osteopenia patients with concomitant SRD receiving glucocorticoids. [ABSTRACT FROM AUTHOR]

Purpose: Functional outcomes of robot-assisted (RA) radical cystectomy (RC) with intracorporeal orthotopic neobladder (i-ON) have been poorly investigated. The study aimed to report functional outcomes of a prospective randomized controlled trial (RCT) comparing open RC (ORC) and RARC with i-ON. Methods: Inclusion criteria were cT2-4/N0/M0, or BCG-failure high-grade urothelial carcinoma, candidate to RC with curative intent. A covariate adaptive randomization process was used, based on the following variables: BMI, ASA score, haemoglobin levels, cT-stage, neoadjuvant chemotherapy, urinary diversion. Day-time continence was defined as "totally dryness", nigh-time continence as pad wetness ≤ 50 cc. Continence recovery probabilities were compared between arms with Kaplan–Meier method and Cox regression analysis was performed to identify predictors of continence recovery. HRQoL outcomes analysis was assessed with a generalized linear mixed effect regression (GLMER) model. Results: Out of 116 patients randomized, 88 received ON. Quantitative analysis of functional outcomes reported similar results in terms of day continence, while a better night continence status in ORC cohort was observed. However, 1-yr day- and night-time continence recovery probabilities were comparable. Night-time micturition frequency < 3 h was the only predictor of nigh-time continence recovery. At GLMER, 1-yr body image and sexual functioning were significantly better in RARC cohort, while urinary symptoms were comparable between arms. Conclusion: Despite superiority of ORC at quantitative night-time pad use analysis, we showed comparable day- and night-time continence recovery probabilities. At 1-yr analysis of HRQoL outcomes, urinary symptoms were comparable between arms, while RARC patients reported lower body image and sexual functioning worsening. [ABSTRACT FROM AUTHOR]

Couples' communication styles are associated with depression following job loss for both job seekers and their partners. The Couples Employment Program (CEP), an eight-session program for couples facing job loss, was developed to integrate job search strategies sessions from the JOBS program with couple communication sessions, targeting job search behavior, motivation, mastery, and couple communication. We hypothesized that CEP would have compensatory effects, such that those who began the program with lower job search behavior, lower motivation, less mastery, and more negative or less positive couple communication would make more gains on these targets, and this would mediate impact on reducing risk for depression. We conducted a randomized field trial of CEP with 1477 heterosexual couples facing recent unemployment. Baseline levels of job search behavior and motivation, but not mastery or depression, moderated the impact of intervention on job seeker depression slopes over 12 months; job seekers reporting less job search behavior and motivation at baseline benefited more. Male partners with higher baseline depression also benefited. Opposite to our hypothesis, baseline levels of couple's communication moderated the impact of intervention such that partners in couples with more negative and less positive communication showed iatrogenic effects. There was no evidence that baseline target levels moderated the impact of the intervention on any of these targets. We speculate that more intensive communication training may be necessary for positive impact. [ABSTRACT FROM AUTHOR]