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Context: The long duration and high cost of anterior cruciate ligament reconstruction (ACLR) rehabilitation can pose barriers to completing rehabilitation, the latter stages of which progress to demanding sport-specific exercises critical for a safe return to sport. A staged approach shifting in-person physiotherapy sessions to later months of recovery may ensure patients undergo the sport-specific portion of ACLR rehabilitation. Design/Objective: To compare postoperative outcomes of knee function in patients participating in a staged ACLR physiotherapy program to patients participating in usual care physiotherapy through a randomized controlled trial. Methods: One hundred sixty-two patients were randomized to participate in staged (n = 80) or usual care physiotherapy (n = 82) following ACLR and assessed preoperatively and postoperatively at 2 weeks, 6 weeks, 3 months, and 6 months. The staged group completed the ACLR rehabilitation protocol at home for the first 3 months, followed by usual care in- person sessions. The usual care group completed in-person sessions for their entire rehabilitation. Outcome measures included the Lower Extremity Functional Scale, International Knee Documentation Committee Questionnaire, pain, range of motion, strength, and hop testing. Results: There were no statistically significant between-group differences in measures of knee function at 6 months postoperative. Patients in the usual care group reported significantly higher International Knee Documentation Committee scores at 3 months postoperative (mean difference = 5.8; 95% confidence interval, 1.3 to 10.4; P = .01). Conclusion: A staged approach to ACLR rehabilitation does not appear to impede knee function at 6 months postoperative but may result in worse patient reported outcomes at early follow-ups. [ABSTRACT FROM AUTHOR]

Background: Early intervention is essential for meaningful disease modification in Alzheimer's disease (AD). Objective: We aimed to determine the efficacy and safety of pharmacologic and nutritional interventions for early AD. Methods: PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched from database inception until 1 September 2023. We included randomized controlled trials that evaluated the efficacy of interventions in early AD. Only interventions that demonstrated efficacy compared to placebo were included in the network meta-analysis (NMA). Then we performed frequentist fixed-effects NMA to rank the interventions. GRADE criteria were used to evaluate the level of evidence. Results: Fifty-eight trials including a total of 33,864 participants and 48 interventions were eligible for inclusion. Among the 48 interventions analyzed, only 6 (12.5%) treatments— ranging from low to high certainty— showed significant improvement in cognitive decline compared to placebo. High certainty evidence indicated that donanemab (standardized mean difference [SMD] –0.239, 95% confidence interval [CI] –0.343 to –0.134) and lecanemab (SMD –0.194, 95% CI –0.279 to –0.108) moderately slowed the clinical progression in patients with amyloid pathology. Additionally, methylphenidate, donepezil, LipiDiDiet, and aducanumab with low certainty showed significant improvement in cognitive decline compared to placebo. However, there was no significant difference in serious adverse events as reported between the six interventions and placebo. Conclusions: Only 12.5% of interventions studied demonstrated efficacy in reducing cognitive impairment in early AD. Donanemab and lecanemab have the potential to moderately slow the clinical progression in patients with amyloid pathology. Further evidence is required for early intervention in AD. [ABSTRACT FROM AUTHOR]

Background Clinical trials of treatments for serious infections commonly use the primary endpoint of all-cause mortality. However, many trial participants survive their infection and this endpoint may not truly reflect important benefits and risks of therapy. The win ratio uses a hierarchical composite endpoint that can incorporate and prioritize outcome measures by relative clinical importance. Methods The win ratio methodology was applied post hoc to outcomes observed in the MERINO trial, which compared piperacillin-tazobactam with meropenem. We quantified the win ratio with a primary hierarchical composite endpoint, including all-cause mortality, microbiological relapse, and secondary infection. A win ratio of 1 would correspond to no difference between the 2 antibiotics, while a ratio <1 favors meropenem. Further analyses were performed to calculate the win odds and to introduce a continuous outcome variable in order to reduce ties. Results With the hierarchy of all-cause mortality, microbiological relapse, and secondary infection, the win ratio estimate was 0.40 (95% confidence interval [CI],.22–.71]; P =.002), favoring meropenem over piperacillin-tazobactam. However, 73.4% of the pairs were tied due to the small proportion of events. The win odds, a modification of the win ratio accounting for ties, was 0.79 (95% CI,.68–.92). The addition of length of stay to the primary composite greatly minimized the number of ties (4.6%) with a win ratio estimate of 0.77 (95% CI,.60–.99; P =.04). Conclusions The application of the win ratio methodology to the MERINO trial data illustrates its utility and feasibility for use in antimicrobial trials. [ABSTRACT FROM AUTHOR]

Background: Active surveillance (AS) is increasingly used to monitor patients with lower risk prostate cancer (PCa). The Prostate Cancer Active Lifestyle Study (PALS) was a randomized controlled trial to determine whether weight loss improves obesity biomarkers on the causal pathway to progression in patients with PCa on AS. Methods: Overweight/obese men (body mass index >25 kg/m2) diagnosed with PCa who elected AS were recruited. The intervention was a 6‐month, individually delivered, structured diet and exercise program adapted from the Diabetes Prevention Program with a 7% weight loss goal from baseline. Control participants attended one session reviewing the US Dietary and Physical Activity Guidelines. The primary outcome was change in glucose regulation from baseline to the end of the 6‐month intervention, which was measured by fasting plasma glucose, C‐peptide, insulin, insulin‐like growth factor 1, insulin‐like growth factor binding protein‐3, adiponectin, and homeostatic model assessment for insulin resistance. Results: Among 117 men who were randomized, 100 completed the trial. The mean percentage weight loss was 7.1% and 1.8% in the intervention and control arms, respectively (adjusted between‐group mean difference, −6.0 kg; 95% confidence interval, −8.0, −4.0). Mean percentage changes from baseline for insulin, C‐peptide, and homeostatic model assessment for insulin resistance in the intervention arm were −23%, −16%, and −25%, respectively, compared with +6.9%, +7.5%, and +6.4%, respectively, in the control arm (all p for intervention effects ≤.003). No significant between‐arm differences were detected for the other biomarkers. Conclusions: Overweight/obese men with PCa undergoing AS who participated in a lifestyle‐based weight loss intervention successfully met weight loss goals with this reproducible lifestyle intervention and experienced improvements in glucose‐regulation biomarkers associated with PCa progression. The Prostate Cancer Active Lifestyle Study was a randomized controlled trial to determine whether weight loss improves obesity biomarkers on the causal pathway to progression in patients with prostate cancer undergoing active surveillance. Overweight/obese men with prostate cancer on active surveillance who participated in a lifestyle‐based weight loss intervention successfully met weight loss goals and experienced improvements in glucose‐regulation biomarkers associated with prostate cancer progression. [ABSTRACT FROM AUTHOR]

Pregnant women often experience anxiety due to pregnancy, negatively impacting their and their fetus' health. Non-pharmacological interventions, such as virtual reality (VR), could reduce anxiety levels, potentially impacting non-stress tests or the physiological responses of the pregnant woman and the fetus. A randomized clinical trial conducted between February and December 2022 involved 286 term pregnant women. They were divided into a VR intervention group (146 women) and a control group (140 women). The intervention consisted of 20 min of 3D glasses with images and sounds during a third-trimester nonstress test. Anxiety was measured using the Spielberg State-Trait Anxiety Inventory (STAI), alongside physiological parameters. The VR group exhibited lower anxiety levels compared to controls (STAI score: Rosenthal's r: −0.54, p = 0.01; state anxiety: Rosenthal's r: −0.40, p = 0.001; trait anxiety: Rosenthal's r: −0.41, p = 0.001). Within the VR group, there was a significant reduction in trait anxiety (Rosenthal's r, 1.27; p < 0.001) and total anxiety (Rosenthal's r, 1.63; p < 0.001) post-intervention, along with decreased systolic blood pressure (p < 0.001), diastolic blood pressure (p < 0.001), and maternal heart rate (p = 0.02). Future research could explore additional pregnancy-related variables, such as postpartum anxiety. The results confirm that the use of VR is beneficial for pregnant women and their fetuses, as it decreases anxiety levels, and improves physiological parameters such as blood pressure and maternal heart rate during the nonstress test. VR is a technique that is easy to integrate into the healthcare system due to its non-invasive and non-pharmacological nature. • Virtual reality has proven to be an effective technique in reducing anxiety of pregnant women during NST. • Anxiety is related to higher blood pressure and heart rate values in pregnant women during NST. • Blood pressure and heart rate in pregnant women improved when virtual reality was used as a therapy. [ABSTRACT FROM AUTHOR]

Depressed patients who have become victim of violence are prone to revictimization. However, no evidence-based interventions aimed at reducing revictimization in this group exist. This multicenter randomized controlled trial evaluated the effectiveness of an internet-based emotion regulation training (iERT) added to TAU in reducing revictimization, emotion dysregulation, and depressive symptoms in recently victimized, depressed patients compared to TAU alone. Adult outpatients (N = 153) with a depressive disorder who had experienced threat, physical assault, or sexual assault within the previous three years were randomly allocated to TAU+iERT (n = 74) or TAU (n = 79). TAU involved psychotherapy (mainly cognitive behavioral therapy [77.8 %]). iERT comprised six guided online sessions focused on the acquisition of adaptive emotion regulation skills. The primary outcome measure was the number of revictimization incidents at 12 months after baseline, measured with the Safety Monitor. Analyses were performed according to the intention-to-treat principle. Both groups showed a large decrease in victimization incidents. Mixed-model negative binomial regression analyses showed that TAU+iERT was not effective in reducing revictimization compared to TAU (IRR = 0.97; 95%CI = 0.64,1.46; p =.886). Linear mixed-model analyses demonstrated that TAU+iERT yielded a larger reduction of emotion dysregulation (B = −7.217; p =.046; Cohens d = 0.33), but not depressive symptoms (B = −1.041; p =.607) than TAU. The study was underpowered to detect small treatment effects. Additionally, uptake of iERT was quite low. Although TAU+iERT resulted in a larger decrease of emotion dysregulation than TAU alone, it was not effective in reducing revictimization and depressive symptoms. Patients' revictimization risk substantially decreased during psychotherapy. • Online emotion regulation training improved emotion regulation in depressed patients. • iERT did not reduce revictimization rates or depressive symptoms compared to TAU. • Violent victimization rates decreased substantially during psychotherapy. [ABSTRACT FROM AUTHOR]

Background: Intracerebral hemorrhage (ICH) is a common stroke type with high morbidity and mortality. There are mainly three surgical methods for treating ICH. Unfortunately, thus far, no specific surgical method has been proven to be the most effective. We carried out this study to investigate whether minimally invasive surgeries with endoscopic surgery or stereotactic aspiration (frameless navigated aspiration) will improve functional outcomes in patients with supratentorial ICH compared with small-bone flap craniotomy. Methods: In this parallel-group multicenter randomized controlled trial conducted at 16 centers, patients with supratentorial hypertensive ICH were randomized to receive endoscopic surgery, stereotactic aspiration, or craniotomy at a 1:1:1 ratio from July 2016 to June 2022. The follow-up duration was 6 months. Patients were randomized to receive endoscopic evacuation, stereotactic aspiration, or small-bone flap craniotomy. The primary outcome was favorable functional outcome, defined as the proportion of patients who achieved a modified Rankin scale (mRS) score of 0–2 at the 6-month follow-up. Results: A total of 733 patients were randomly allocated to three groups: 243 to the endoscopy group, 247 to the aspiration group, and 243 to the craniotomy group. Finally, 721 patients (239 in the endoscopy group, 246 in the aspiration group, and 236 in the craniotomy group) received treatment and were included in the intention-to-treat analysis. Primary efficacy analysis revealed that 73 of 219 (33.3%) in the endoscopy group, 72 of 220 (32.7%) in the aspiration group, and 47 of 212 (22.2%) in the craniotomy group achieved favorable functional outcome at the 6-month follow-up (P =.017). We got similar results in subgroup analysis of deep hemorrhages, while in lobar hemorrhages the prognostic outcome was similar among three groups. Old age, deep hematoma location, large hematoma volume, low preoperative GCS score, craniotomy, and intracranial infection were associated with greater odds of unfavorable outcomes. The mean hospitalization expenses were ¥92,420 in the endoscopy group, ¥77,351 in the aspiration group, and ¥100,947 in the craniotomy group (P =.000). Conclusions: Compared with small bone flap craniotomy, endoscopic surgery and stereotactic aspiration improved the long-term outcome of hypertensive ICH, especially deep hemorrhages. Trial Registration: ClinicalTrials.gov Identifier: NCT02811614. [ABSTRACT FROM AUTHOR]

Background: There is no known effective pharmacological therapy for long COVID, which is characterized by wide-ranging, multisystemic, fluctuating, or relapsing symptoms in a large proportion of survivors of acute COVID. This randomized controlled trial aims to assess the safety and efficacy of an anti-inflammatory agent colchicine, to reduce symptoms among those at high risk of developing long COVID. Methods: This multi-centre, parallel arm, 1:1 individual randomized, placebo-controlled, double-blind superiority trial will enrol 350 individuals with persistent post-COVID symptoms. Participants will be randomized to either colchicine 0.5 mg once daily (< 70 kg) or twice daily (≥ 70 kg) or matched placebo for 26 weeks and will be followed up until 52 weeks after randomization. The primary trial objective is to demonstrate the superiority of colchicine over a placebo in improving distance walked in 6 min at 52 weeks from baseline. The secondary objectives are to assess the efficacy of colchicine compared to placebo with respect to lung function, inflammatory markers, constitutional symptoms, and mental health state. In a sub-sample of 100 participants, cardiac biomarkers of myocardial injury and myocardial oedema using MRI will be compared. Discussion: Persistent inflammatory response following SARS-CoV-19 is one of the postulated pathophysiological mechanisms of long COVID. Colchicine, a low-cost anti-inflammatory agent, acts via multiple inflammatory pathways and has an established safety profile. This trial will generate evidence for an important health priority that can rapidly translate into practice. Trial registration: This clinical trial has been registered prospectively on www.clinicaltrials.gov with registration CTRI/2021/11/038234 dated November 24, 2021. [ABSTRACT FROM AUTHOR]

Background: Nearly two-thirds of family caregivers of persons living with Alzheimer's disease or related dementias (AD/ADRD) provide complex care, including medical care. Family caregivers typically receive little to no training on how to provide this care. Furthermore, family caregivers simultaneously grapple with the presence of behavioral and psychological symptoms of dementia (BPSD), diminished communication abilities, and comorbidities such as diabetes. We developed Learning Skills Together (LST), a 6-week digitally delivered psychoeducational program, to facilitate family caregiver abilities to administer complex care tasks. The goal of the present study is to test the efficacy of LST and to reduce adverse outcomes associated with caregiving, such as depressive symptomology and negative appraisal of BPSD. Methods: To test the efficacy of LST, we will conduct a two-arm single-site randomized controlled trial (RCT) with N = 200 family caregivers of persons living with AD/ADRD. Eligible family caregivers will be randomly assigned to participate in either the LST intervention or a structurally equivalent control condition focused on healthy living. All family caregivers will complete four surveys, including a baseline survey administered prior to randomization, a post-intervention survey, and a 3- and 6-month follow-up survey to assess change in study outcomes. Between-group comparisons of each outcome will be evaluated using generalized estimating equation models. Mediation analyses will assess family caregiver self-efficacy as the intervention's mechanism of change in depressive symptomology and BPSD. We will also examine caregiver race, ethnicity, and gender as effect modifiers of the intervention. Discussion: LST findings will inform the field of AD/ADRD and caregiving regarding optimally supporting family caregivers in managing complex care tasks. If efficacious, the LST intervention will support family caregivers in preserving their own mental health while providing complex care. Trial registration: Clinical Trials.gov NCT05846984. This study was registered on May 6, 2023. [ABSTRACT FROM AUTHOR]

Background: Although hematopoietic stem cell transplantation provides the chances of survival for aplastic anemia patients, it is also related to many treatment-related physical and psychological side effects that severely influence the quality of life. Exercise interventions have shown positive results in mixed hematology populations. The study aims to determine the effectiveness of exercise rehabilitation in improving the quality of life, fatigue, and physical function in these patients. Methods: The study will enroll a total of 82 aplastic anemia patients receiving hematopoietic stem cell transplantation. They will be randomly divided into two groups in a 1:1 ratio. The intervention group will participate in structured exercise rehabilitation (plus usual care), while control group participants will receive usual care. The exercise rehabilitation program will be performed from neutrophil and platelet engraftment until 100 days after transplantation. All outcomes will be measured at the following time points: the neutrophil and platelet engraftment (± 1day, T0), discharge from the transplantation module (± 1 day, T1), hospital discharge (± 1 day, T2), and 100 days post-transplantation (± 5 days, T3). Discussion: This study aims to assess the effectiveness of exercise rehabilitation for aplastic anemia patients receiving hematopoietic stem cell transplantation in a Chinese single center. It is particularly vital to conduct the studies in this population. Moreover, the evidence obtained from the study will provide evidence for future research and clinical practice to exercise in aplastic anemia patients. Trial registration: ChiCTR2200060762. Registered on May 2022, www.trialregister.nl/trial/7702. [ABSTRACT FROM AUTHOR]

Background: There is general agreement that sexuality is a central aspect of human development; it is key in sexual health and reproductive education during adolescence. However, in spite of the existing interventions on this topic and the evidence generated, the inclusion of a gender focus in sexuality is relatively recent and there is little evidence available, thus structured and corroborated interventions with a gender-transforming perspective in sexuality are required. Methods: We will use a mixed method experimental design with a parallel cluster-randomized trial (GRTs) that will evaluate the effectiveness of a comprehensive gender-transformative intervention of sexual education (ENFOCATE -Focus-on-), which will be complemented with qualitative studies to understand the implementation process. The participants will be 609 10th and 11th-grade students. The randomization will be by grade, and the data will be collected at three moments (pre-intervention, post-intervention, and a 3-month follow-up). Discussion: Comprehensive, gender-focused, and culturally pertinent interventions in sexuality are needed for adolescents of countries with high, middle, and low incomes. These produce better results in terms of sexual health, and including a gender-transformative focus contributes to equity in health. Focus-on is unique since it uses a comprehensive gender-transformative intervention in sexual education that will allow putting into practice a program based both on international evidence and that which arises from the object population. It also uses a culturally-sensitive focus, since it is designed based on the characteristics of the object population; it will allow adapting some activities to the needs of the context in which it is developed. Trial registration: The study was prospectively registered on June 6, 2023, at ClinicalTrials.gov ID: NCT05896540. Protocol version number 1.0. May 22, 2023. [ABSTRACT FROM AUTHOR]

Background: Although hematopoietic stem cell transplantation provides the chances of survival for aplastic anemia patients, it is also related to many treatment-related physical and psychological side effects that severely influence the quality of life. Exercise interventions have shown positive results in mixed hematology populations. The study aims to determine the effectiveness of exercise rehabilitation in improving the quality of life, fatigue, and physical function in these patients. Methods: The study will enroll a total of 82 aplastic anemia patients receiving hematopoietic stem cell transplantation. They will be randomly divided into two groups in a 1:1 ratio. The intervention group will participate in structured exercise rehabilitation (plus usual care), while control group participants will receive usual care. The exercise rehabilitation program will be performed from neutrophil and platelet engraftment until 100 days after transplantation. All outcomes will be measured at the following time points: the neutrophil and platelet engraftment (± 1day, T0), discharge from the transplantation module (± 1 day, T1), hospital discharge (± 1 day, T2), and 100 days post-transplantation (± 5 days, T3). Discussion: This study aims to assess the effectiveness of exercise rehabilitation for aplastic anemia patients receiving hematopoietic stem cell transplantation in a Chinese single center. It is particularly vital to conduct the studies in this population. Moreover, the evidence obtained from the study will provide evidence for future research and clinical practice to exercise in aplastic anemia patients. Trial registration: ChiCTR2200060762. Registered on May 2022, www.trialregister.nl/trial/7702. [ABSTRACT FROM AUTHOR]

Background: There is general agreement that sexuality is a central aspect of human development; it is key in sexual health and reproductive education during adolescence. However, in spite of the existing interventions on this topic and the evidence generated, the inclusion of a gender focus in sexuality is relatively recent and there is little evidence available, thus structured and corroborated interventions with a gender-transforming perspective in sexuality are required. Methods: We will use a mixed method experimental design with a parallel cluster-randomized trial (GRTs) that will evaluate the effectiveness of a comprehensive gender-transformative intervention of sexual education (ENFOCATE -Focus-on-), which will be complemented with qualitative studies to understand the implementation process. The participants will be 609 10th and 11th-grade students. The randomization will be by grade, and the data will be collected at three moments (pre-intervention, post-intervention, and a 3-month follow-up). Discussion: Comprehensive, gender-focused, and culturally pertinent interventions in sexuality are needed for adolescents of countries with high, middle, and low incomes. These produce better results in terms of sexual health, and including a gender-transformative focus contributes to equity in health. Focus-on is unique since it uses a comprehensive gender-transformative intervention in sexual education that will allow putting into practice a program based both on international evidence and that which arises from the object population. It also uses a culturally-sensitive focus, since it is designed based on the characteristics of the object population; it will allow adapting some activities to the needs of the context in which it is developed. Trial registration: The study was prospectively registered on June 6, 2023, at ClinicalTrials.gov ID: NCT05896540. Protocol version number 1.0. May 22, 2023. [ABSTRACT FROM AUTHOR]

Background: Human papillomavirus (HPV) infections can cause cancers of the cervix, vagina, vulva, penis, anus, and oropharynx. The most recently approved HPV vaccine, Gardasil-9, protects against HPV infection and can prevent HPV-associated invasive cancers. However, Gardasil-9 is one of the most underused vaccines in the US today. Young adults are at risk for HPV infection, but many are not vaccinated. This study uses a randomized controlled trial (RCT) to test an innovative multilevel intervention to increase HPV vaccination rates among young adults. In this paper, we describe the research protocol. Methods: The study uses a two by three factorial design. A total of 1200 young adults in Texas, age 18–26 years, who have not been previously fully vaccinated against HPV will be randomly assigned to one of six conditions to receive: (1) standard CDC information about HPV vaccination (control); (2) video narratives about HPV vaccination; (3) written narratives about HPV vaccination; or (4–6) enhanced access to HPV vaccine combined with (4) standard CDC information, (5) video narratives, or (6) written narratives. The two primary outcomes are the rate of HPV vaccination initiation by 3-month follow-up and rate of HPV vaccination completion by 9-month follow-ups. We will determine the impact of the individual level intervention (i.e., persuasive narratives through video or written format), the systemic level intervention (i.e., enhanced access to HPV vaccines), and the combination of both levels, on HPV vaccination initiation and completion. We will also use purposive sampling to select participants to take part in semi-structured interviews/focus groups to better understand the mechanisms of the intervention. Discussion: Recruitment and data collection began in March 2022. We expect to complete data collection by March 2026. We expect that narratives, enhanced access, and the combination of both will improve HPV vaccination initiation and completion rates among young adults. If proven successful, these individual- and system-level interventions can be easily disseminated in regions with low HPV vaccination rates to improve HPV vaccination, and ultimately decrease HPV-related cancer burden. Trial Registration: NCT05057312. [ABSTRACT FROM AUTHOR]

Background: There is a high incidence of nonspecific Low Back Pain (LBP) in patients visiting Emergency Departments (EDs), but there is a lack of knowledge regarding emergency physiotherapy for LBP. The effect of on-site physiotherapy in these patients was therefore never demonstrated. We assessed short-term outcomes, feasibility and patient satisfaction with physiotherapy in ED patients presenting with nonspecific LBP. Methods: A block-randomized, controlled, open-label trial with a follow-up of 42 days. Patients aged 18 years or older presenting to an ED with nonspecific LBP were prospectively enrolled. Both groups received the same booklet with written information on LBP management and exercises. Patients in the intervention group were given additional instructions by a certified physiotherapist. Results: We included 86 patients in the primary analysis. The median age was 40, and 40.7% were female. At day 7, the median Oswestry Disability Index (ODI) was 2 points lower in the intervention group compared to the control group, which was not statistically significant. There was no between-group difference in pain at day 7. Patients who received physiotherapy felt significantly more confident with the exercises they were taught (p = 0.004, effect size = 0.3 [95% CI 0.1 to 0.5]). Conclusions: On-site physiotherapy in ED patients presenting with nonspecific low back pain is associated with higher patient satisfaction, compared to standard of care. The effect of physiotherapy was small, with only minimal improvement in disability, but without a reduction in pain. Despite the very small effect size, physiotherapeutic interventions should be investigated in larger cohorts with an extended intervention including patient education, exercises, and other physiotherapeutic modalities. [ABSTRACT FROM AUTHOR]

Objective: The objective was to assess the one year implant treatment outcome and patient‐related outcome measures (PROMs) following maxillary sinus floor augmentation (MSFA) with autogenous bone graft (ABG) from the zygomatic buttress (control) compared with 1:1 mixture of ABG and anorganic porcine bone mineral (APBM) (Test I) or biphasic bone graft material (BBGM) (Test II). Materials and Methods: Sixty healthy patients (34 females, 26 males) were randomly allocated to either control or test groups. Outcome measures included survival of suprastructures and implants, implant stability quotient, health status of peri‐implant tissue, peri‐implant marginal bone loss, frequency of complications, and PROMs using Oral Health Impact Profile‐14 combined with questionnaire assessing patient perception of peri‐implant soft tissue, prosthetic solution, implant function, and implant treatment outcome using visual analogue scale. Mean differences were expressed with standard deviation and 95% confidence interval. Level of significance was.05. Results: All suprastructures and implants were well‐functioning after one year of functional implant loading. There was no significant difference between control and test groups in any of the applied outcome measures. The implant stability significantly increased from implant placement to abutment connection within all groups (p <.001). High patient satisfaction and significant improvement in oral health‐related quality of life was also reported within all groups. Conclusion: This study demonstrates that MSFA with composite grafts containing minimal amounts of ABG reveals comparable implant treatment outcomes as compared with ABG alone, after one year of functional implant loading. Extensive ABG harvesting in conjunction with MSFA therefore seems not to be needed. [ABSTRACT FROM AUTHOR]

Financial education represents a powerful tool for improving economic literacy of citizens. This paper presents results from an experiment providing a group of 136 workers in an Italian university (administrative staff) an online, synchronous course. Classes were organized in 5 sessions of 2h each and covered basic topics about personal finance. The effectiveness of the course is assessed through a rigorous randomized controlled trial (RCT). In addition to the analysis of improvements in financial knowledge, financial self‐efficacy and the role of prior attitudes and behaviors were explored. Participants obtained post‐test scores statistically higher than individuals in the control group, with an average effect size of 0.55 SD. The effect is particularly relevant for participants starting with low levels of financial knowledge. Moreover, two novel findings emerge: financial self‐efficacy increases (0.51 SD) after the course, and pre‐treatment individuals' financial attitudes and behaviors shed further light on the financial learning process. [ABSTRACT FROM AUTHOR]

Objective: Conventional randomized controlled trials (RCTs) have long served as the foundation of research in clinical psychology; however, most treatments for eating disorders show only modest effects on reduction of symptoms and maintenance of long‐term remission. New options for psychotherapy treatment development research, beyond continuing to pursue additive or subpopulation approaches, are needed. Methods: One option is to apply dose–response designs, which are commonplace in studies of pharmacology, toxicology, and medical research, and characterized by the evaluation of the amount of exposure (dose) to an intervention, and the resulting changes in body function or health (response). Results: Eating disorder interventions are particularly well‐suited for dose–response treatment designs. The deadly nature of eating disorders makes it imperative that patients are not turned away for not being "ready" to engage with treatment. By identifying optimal doses, research will likely yield a more parsimonious course of treatment, which will lend itself to reduced costs, greater uptake, and reduced drop‐out. Discussion: Limited use of within‐subject designs in trials for patients with eating disorders has produced fast‐track efficacy studies and omitted key elements in the treatment development pathway. To decrease reliance on RCT's, dose–response methods should be applied as an alternative study design. Public Significance: Eating disorders are associated with medical and psychiatric comorbidities, poor quality of life, and high mortality. Access to evidence‐based services for patients with eating disorders is limited, and identifying additional effective treatment options can be difficult because of challenges inherent to randomized‐controlled trials. This manuscript describes an alternative trial methodology to maximize the information that can be gathered prior to utilizing a standard large‐scale efficacy design. [ABSTRACT FROM AUTHOR]

Disruptive behavior during adolescence is linked to severe problems for the youths later in life and poses challenges to the families, schools, and treatment systems these youths meet. This randomized controlled trial was conducted to examine the short- and long-term effectiveness of functional family therapy (FFT) for adolescents aged 11–17 referred for disruptive behavior to Child Welfare Services in Norway. One hundred sixty-one youths (Mage = 14.7, 45.9% female) were randomly assigned to FFT (n = 88) or treatment as usual (TAU, n = 73). Primary outcomes were parent- and teacher-reported youth aggressive behavior, rule-breaking behavior, internalizing problems, and social skills; youth self-reported delinquency (SRD) and negative peer involvement; and teacher-reported academic performance and adaptive functioning. Outcomes were collected before treatment (pretest), 6 months after pretest (posttest), and 18 months after pretest (follow-up). The results showed no intervention effect for FFT compared to TAU between pretest and posttest (p >.05). Significant improvements between pretest and posttest were found for youth receiving both FFT and TAU on parent-reported aggressive and rule-breaking behavior, internalizing problems, and social skills (ranging from d = 0.56 to −0.45) and youth SRD (d = 0.29). Between posttest and follow-up, however, a significant intervention effect in favor of TAU was found for parent-reported youth internalizing (d = 0.27). Significant improvements between posttest and follow-up were also found for youth receiving both FFT and TAU on parent- and teacher-reported aggressive behavior. Findings did not support the hypothesized superiority of FFT over TAU. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to compare the hemodynamic effects of remimazolam- and propofol-based total intravenous anesthesia in patients who underwent transcatheter aortic valve replacement. Methods: This was a single-center, single-blind, randomized controlled trial set at Nara Medical University, Kashihara, Japan. We included 36 patients aged ≥ 20 years scheduled to undergo elective transfemoral transcatheter aortic valve replacement (TAVR) under general anesthesia. The participants were randomly assigned to the remimazolam and propofol groups (n = 18 each). Remimazolam- or propofol-based total intravenous anesthesia was initiated at 12 mg/kg/min or 2.5 mcg/mL via target-controlled infusion, respectively, along with remifentanil. After confirming the loss of consciousness, the administration rate was adjusted using electroencephalographic monitoring. The primary outcome was the rate of arterial hypotension, defined as a mean arterial pressure < 60 mmHg, from anesthesia induction until the beginning of the surgical incision. The total doses of ephedrine and phenylephrine were also assessed. Results: During anesthesia induction, the arterial hypotension rates were 11.9% and 21.6% in the remimazolam and propofol groups, respectively (P = 0.01). The total dose of ephedrine was higher in the propofol group (14.4 mg) than in the remimazolam group (1.6 mg) (P < 0.001); however, the total dose of phenylephrine was not significantly different between the two groups (propofol 0.31 mg vs. remimazolam: 0.17 mg, P = 0.10). Conclusion: Remimazolam-based total intravenous anesthesia resulted in a lower hypotension rate than propofol-based total intravenous anesthesia during induction in patients undergoing TAVR. Remimazolam-based total intravenous anesthesia can be used safely during anesthetic induction in patients with severe aortic stenosis. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study was to examine the acute and chronic effects of wild blueberry supplementation on mood, executive function, and serum biomarkers of neuroplasticity, inflammation, and oxidative stress in emerging adults with moderate-to-severe depressive symptoms. Methods: In this double-blind trial, 60 emerging adults (Mage = 20.0 years, 32% male) with self-reported depressive symptoms were randomly assigned to receive a single blueberry drink (acute phase), followed by 6 weeks of daily blueberry supplementation (chronic phase), or a matched placebo drink. The primary outcome was Beck Depression Inventory-II (BDI-II) scores at 6-week follow-up. Further measures included momentary affect (PANAS-X) and accuracy on an executive function task. The data were analyzed using ANCOVAs adjusted for baseline values, sex, and habitual fruit and vegetable intake. Estimated marginal means were calculated to compare the treatment arms. Results: The blueberry drink significantly improved positive affect (p = 0.026) and executive function (p = 0.025) at 2 h post-ingestion, with change scores being positively correlated in the blueberry group (r = 0.424, p = 0.017). However, after six weeks of supplementation the reduction in BDI-II scores was greater in the placebo group by 5.8 points (95% CI: 0.8–10.7, p = 0.023). Generalized anxiety and anhedonia also decreased significantly more in the placebo group. No significant differences were found for any of the biomarkers. Conclusions: Six weeks of wild blueberry supplementation were inferior to placebo in reducing depressive symptoms. Nevertheless, the correlated improvements in positive affect and executive function after a single dose of blueberries point to a beneficial, albeit transient, psychological effect. These contrasting results suggest a biphasic, hormetic-like response that warrants further investigation. Trial registration: NCT04647019, dated 30 November, 2020. [ABSTRACT FROM AUTHOR]

To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge. Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL). The experimental group also received experimental occupational therapy services to address goals identified through the administration of the Canadian Occupational Performance Measure (COPM). Experimental occupational therapy began during the in-hospital phase and continued in the home-based setting. It consisted of teaching strategies, recommending aids, and providing personalized information regarding available community support. Ninety-two individuals with a mean age of 65 years (female 44.6%) were enrolled. The experimental group significantly improved participation measured by the Reintegration to Normal Living Index (mean changes 8.61, 95% CI: 1–16.23, p = 0.027). The performance and satisfaction scores of the COPM, both during hospitalization and after discharge, and independence in ADL also improved. No differences in mood disturbances were found. Early post-discharge occupational therapy integrated with multidisciplinary rehabilitation improves the social participation of complex patients. Future research should investigate the concrete feasibility of implementing this complex intervention cost-effectively and in different contexts. ClinicalTrials.gov Identifier NCT03668938 (first posted date 13/09/2018) Early post-discharge rehabilitation assists patients' transition from hospital to home by improving the management of problems they encounter. In complex patients, occupational therapy initiated during hospitalization and extended to the early post-discharge phase improves social participation, independence in basic and instrumental daily activities, and performance and satisfaction when carrying out relevant occupational activities. The strong partnership between the Occupational Therapist and the patient improves compliance to treatment, enhancing the chances of success of rehabilitation interventions. [ABSTRACT FROM AUTHOR]

Fibromyalgia is a debilitating pain condition for which treatment effects are typically modest. The most evaluated psychological treatment is traditional cognitive behavior therapy (T-CBT), but promising effects have recently been seen in exposure-based cognitive behavior therapy (Exp-CBT). We investigated whether Exp-CBT was superior to T-CBT in a randomized controlled trial. Self-referred participants with fibromyalgia (N = 274) were randomized (1:1) to 10 weeks of Exp-CBT or T-CBT. Treatments were delivered online and presented as "CBT for fibromyalgia." Participants were assessed at baseline, weekly during treatment, posttreatment, and at 6- and 12-month follow-up. Primary outcome was the difference in reduction in fibromyalgia severity as measured using the Fibromyalgia Impact Questionnaire (FIQ) over 11 assessment points from baseline to posttreatment, modelled within an intention-to-treat framework using linear mixed effects models fitted on multiple imputed data. Approximately 91% of weekly FIQ scores were collected over the main phase. There was no significant difference between Exp-CBT and T-CBT in the mean reduction of fibromyalgia severity from pretreatment to posttreatment (b = 1.3, 95% CI -3.0 to 5.7, P = 0.544, d = -0.10). Minimal clinically important improvement was seen 60% in Exp-CBT vs 59% in T-CBT. Effects were sustained up to 12 months posttreatment. This well-powered randomized trial indicated that Exp-CBT was not superior to T-CBT for fibromyalgia. Both treatments were associated with a marked reduction in fibromyalgia severity, and the online treatment format might be of high clinical utility. T-CBT can still be regarded a reference standard treatment that remains clinically relevant when compared to novel treatment approaches. [ABSTRACT FROM AUTHOR]

Background: The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) showed cognitive benefits from a multidomain lifestyle intervention in at-risk older people. The LipiDiDiet trial highlighted benefits of medical food in prodromal Alzheimer's disease (AD). However, the feasibility and impact of multimodal interventions combining lifestyle with medical food in prodromal AD is unclear. Methods: MIND-ADmini was a 6-month multinational (Sweden, Finland, Germany, France) proof-of-concept randomized controlled trial (RCT). Participants were 60–85 years old, had prodromal AD (International Working Group-1 criteria), and vascular/lifestyle risk factors. The parallel-group RCT had three arms: multimodal lifestyle intervention (nutritional guidance, exercise, cognitive training, vascular/metabolic risk management and social stimulation); multimodal lifestyle intervention + medical food (Fortasyn Connect); and regular health advice/care (control). Participants were randomized 1:1:1 (computer-generated allocation at each site). Outcome evaluators were blinded to randomization. Primary outcome was feasibility of the multimodal intervention, evaluated by recruitment rate during a 6-month recruitment phase, overall adherence in each intervention arm, and 6-month retention rate. Successful adherence was pre-specified as attending ≥ 40% of sessions/domain in ≥ 2/4 domains (lifestyle intervention), and consuming ≥ 60% of the medical food (lifestyle intervention + medical food). The secondary outcomes included adherence/participation to each intervention component and overall adherence to healthy lifestyle changes, measured using a composite score for healthy lifestyle. Cognitive assessments were included as exploratory outcomes, e.g. Clinical Dementia Rating scale. Results: During September 2017-May 2019, 93 individuals were randomized (32 lifestyle intervention, 31 lifestyle + medical food, and 30 control group). Overall recruitment rate was 76.2% (64.8% during the first 6 months). Overall 6-month retention rate was 91.4% (lifestyle intervention 87.5%; lifestyle + medical food 90.3%; control 96.7%). Domain-specific adherence in the lifestyle intervention group was 71.9% to cognitive training, 78.1% exercise, 68.8% nutritional guidance, and 81.3% vascular risk management; and in the lifestyle + medical food group, 90.3% to cognitive training, 87.1% exercise, 80.7% nutritional guidance, 87.1% vascular risk management, and 87.1% medical food. Compared with control, both intervention arms showed healthy diet improvements (βLifestyle×Time = 1.11, P = 0.038; βLifestyle+medical food×Time = 1.43, P = 0.007); the lifestyle + medical food group also showed vascular risk reduction (P = 0.043) and less cognitive-functional decline (P < 0.05, exploratory analysis). There were 5 serious adverse events (control group: 1; lifestyle intervention: 3; lifestyle + medical food: 1) unrelated to interventions. Conclusions: The multidomain lifestyle intervention, alone or combined with medical food, had good feasibility and adherence in prodromal AD. Longer-term cognitive and other health benefits should be further investigated in a larger-scale trial. Trial registration: ClinicalTrials.gov NCT03249688. [ABSTRACT FROM AUTHOR]

Background: Despite the improvements in the completeness of reporting of randomized trial protocols after the publication of the Standard Protocol Items: Recommendations for Interventional Trial (SPIRIT) guidelines, many items remain poorly reported. This study aimed to assess the effectiveness of using SPIRIT-tailored templates for trial protocols to improve the completeness of reporting of the protocols that master's students write as part of their master's theses. Methods: Before and after experimental study performed at the University Master's Degree in Orthopaedic Manual Physiotherapy of the Universitat Internacional de Catalunya (Barcelona, Spain). While students in the post-intervention period were instructed to use a trial protocol template that was tailored to SPIRIT, students in the pre-intervention period did not use the template. Primary outcome: Difference between the pre- and post-intervention periods in the mean number of adequately reported items (0–10 scale). The outcomes were evaluated independently and in duplicate by two blinded assessors. Students and their supervisors were not aware that they were part of a research project. For the statistical analysis, we used a generalized linear regression model (dependent variable: number of adequately reported items in the protocol; independent variables: intervention period, call, language). Results: Thirty-four trial protocols were included (17, pre-intervention; 17, post-intervention). Protocols produced during the post-intervention period (mean: 8.24; SD: 1.52) were more completely reported than those produced during the pre-intervention period (mean: 6.35; SD: 1.80); adjusted difference: 1.79 (95% CI: 0.58 to 3.00). Conclusions: SPIRIT-based templates could be used to improve the completeness of reporting of randomized trial protocols. [ABSTRACT FROM AUTHOR]

Background: Despite the implementation of various postoperative management strategies, the prevalence of postoperative fatigue syndrome (POFS) remains considerable among individuals undergoing laparoscopic radical gastrectomy. While the N-methyl-D-aspartic acid receptor antagonist esketamine has demonstrated efficacy in enhancing sleep quality and alleviating postoperative pain, its impact on POFS remains uncertain. Consequently, the objective of this study is to ascertain whether perioperative administration of esketamine can effectively mitigate the occurrence of POFS in patients undergoing laparoscopic radical gastrectomy. Methods: A total of 133 patients diagnosed with gastric cancer were randomly assigned to two groups, namely the control group (Group C) (n = 66) and the esketamine group (Group E) (n = 67), using a double-blind method. The Group C received standardized anesthesia, while the Group E received esketamine in addition to the standardized anesthesia. The primary outcome measure assessed was the Christensen fatigue score at 3 days after the surgical procedure, while the secondary outcomes included the disparities in postoperative fatigue, postoperative pain, sleep quality, and adverse reactions between the two groups. Results: In the group receiving esketamine, the fatigue scores of Christensen on the third day after surgery were significantly lower compared to the Group C (estimated difference, -0.70; 95% CI, -1.37 to -0.03; P = 0.040). Additionally, there was a significant decrease in the occurrence of fatigue in the Group E compared to the Group C on the first and third days following surgery (P < 0.05). Also, compared to individuals who had distal gastrectomy, those who had entire gastrectomy demonstrated a higher degree of postoperative tiredness reduction with esketamine. Furthermore, the Group E exhibited reduced postoperative pain and improved sleep in comparison to the Group C. Both groups experienced similar rates of adverse events. Conclusions: The use of esketamine during the perioperative period can improve POFS after laparoscopic radical gastrectomy, without adverse reactions. Trial registration: Registered in the Chinese Clinical Trial Registry (ChiCTR2300072167) on 05/06 /2023. [ABSTRACT FROM AUTHOR]

Background: There is inconsistent utilisation of clinical practice guidelines (CPGs) for cardiovascular disease (CVD) screening and management by healthcare professionals to identify CVD risk factors early and to intervene using current recommendations. To address this issue, the Cardiovascular Assessment Screening Program (CASP) was developed, implemented, and evaluated. This manuscript reports on the second phase of an exploratory sequential mixed methods study that tested the effectiveness of the CASP with nurse practitioners (NPs) and patients in Canada. Methods: A two-armed, non-blinded, cluster randomised controlled trial (cRCT) compared the NP-led implementation of CASP with usual care by NPs in community practice clinics across one Canadian province. The NPs were the cluster variable as their screening practices could be affected by their educational training, resources, or other factors. NPs were eligible for inclusion in the study if they were located in different urban and rural community settings and could conduct follow-up visits with patients. NPs recruited and enrolled the patients from their own practices as participants if they were healthy individuals, aged 40–74 years, with no established CVD or vascular disease. Researchers randomly allocated the NPs (n = 10) to the intervention group (IG) or the control group (CG). Results: Eight (8) NPs and 167 patients participated in the cRCT study. Patient participant-level data were analysed by the originally assigned groups IG (n = 68) and CG (n = 99). Utilising GLM (generalized linear modeling) more IG patients (90%; n = 61) received comprehensive CVD screening compared to the CG patients (2%; n = 2), RR = 30.2, 95% CI [8.76, 103.9], p <.0001, controlling for the effect of NP and BP category. Conclusion: NP implementation of CASP was effective for comprehensive screening compared to usual care and led to identifying previously unknown CVD risk factors, calculated FRS, heart health priorities and personalised goal-setting. Trial registration: ClinicalTrial.gov ID#: NCT03170752, date of registration 2017/05/31. [ABSTRACT FROM AUTHOR]

Background: Heart failure and type 2 diabetes are prevalent public health issues in Europe. These complex chronic conditions require extensive pharmacological management, ongoing self-care, and behavioral changes. Despite the known benefits of lifestyle changes, such as regular exercise and better control of blood sugar levels, patients may need help implementing the recommended changes. This study aims to assess the effectiveness of a telemedicine program for managing heart failure and type 2 diabetes at home. The program focuses on promoting lifestyle changes. Methods and analysis: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to either an intervention or control group in a 1:1 ratio. The intervention group receives support from a nursing case manager through a structured home-based teleassistance program and a trainer for daily physical activity stimulation. They also have access to teleconsultations with cardiologists and diabetes specialists as needed, telemonitoring of vital signs, and daily step tracking. An app records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients can also self-report symptoms and communicate via a chat and videoconference system with a Nurse Case Manager. The control group receives routine care. Data collection occurs before intervention and 6 months after baseline during a new outpatient cardiology evaluation. The primary outcome is to measure the difference in the distance walked during a 6-min walk test between baseline and after 6 months. The key secondary outcomes include improving the disease status and physical activity profile. Data will be analyzed according to the intention-to-treat principles. Discussion: This study will provide evidence on the efficacy of a telemedicine home-based management model to maintain correct lifestyles in patients with both heart failure and type 2 diabetes, improving self-management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early. Trial registration: ClinicalTrials.gov NCT05633784. Registered on November 30, 2022. [ABSTRACT FROM AUTHOR]

Background: It is unclear whether brief interventions using the combined classification of alcohol-metabolizing enzymes aldehyde dehydrogenase 2 (ALDH2) and alcohol dehydrogenase 1B (ADH1B) together with behavioral changes in alcohol use can reduce excessive alcohol consumption. This study aimed to examine the effects of a brief intervention based on the screening of ALDH2 and ADH1B gene polymorphisms on alcohol consumption in Japanese young adults. Methods: In this open-label randomized controlled trial, we enrolled adults aged 20–30 years who had excessive drinking behavior (average amount of alcohol consumed: men, ≥ 4 drinks/per day and women, ≥ 2 drinks/per day; 1 drink = 10 g of pure alcohol equivalent). Participants were randomized into intervention or control group using a simple random number table. The intervention group underwent saliva-based genotyping of alcohol-metabolizing enzymes (ALDH2 and ADH1B), which were classified into five types. A 30-min in-person or online educational counseling was conducted approximately 1 month later based on genotyping test results and their own drinking records. The control group received traditional alcohol education. Average daily alcohol consumption was calculated based on the drinking diary, which was recorded at baseline and at 3 and 6 months of follow-up. The primary endpoint was average daily alcohol consumption, and the secondary endpoints were the alcohol-use disorder identification test for consumption (AUDIT-C) score and behavioral modification stages assessed using a transtheoretical model. Results: Participants were allocated to the intervention (n = 100) and control (n = 96) groups using simple randomization. Overall, 28 (29.2%) participants in the control group and 21 (21.0%) in the intervention group did not complete the follow-up. Average alcohol consumption decreased significantly from baseline to 3 and 6 months in the intervention group but not in the control group. The reduction from baseline alcohol consumption values and AUDIT-C score at 3 months were greater in the intervention group than in the control group (p < 0.001). In addition, the behavioral modification stages were significantly changed by the intervention (p < 0.001). Conclusions: Genetic testing for alcohol-metabolizing enzymes and health guidance on type-specific excessive drinking may be useful for reducing sustained average alcohol consumption associated with behavioral modification. Trial registration: R000050379, UMIN000044148, Registered on June 1, 2021. [ABSTRACT FROM AUTHOR]

Background: The primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the Mediterranean diet for people with bipolar disorder (BD) who have symptoms of sleep disorders or circadian rhythm sleep–wake disruption. This work builds on the growing evidence that TRE has benefits for improving circadian rhythms. TRE and Mediterranean diet guidance will be offered remotely using self-help materials and an app, with coaching support. Methods: This study is an international RCT to compare the effectiveness of TRE and the Mediterranean diet. Three hundred participants will be recruited primarily via social media. Main inclusion criteria are: receiving treatment for a diagnosis of BD I or II (confirmed via DIAMOND structured diagnostic interview), endorsement of sleep or circadian problems, self-reported eating window of ≥ 12 h, and no current mood episode, acute suicidality, eating disorder, psychosis, alcohol or substance use disorder, or other health conditions that would interfere with or limit the safety of following the dietary guidance. Participants will be asked to complete baseline daily food logging for two weeks and then will be randomly allocated to follow TRE or the Mediterranean diet for 8 weeks, during which time, they will continue to complete daily food logging. Intervention content will be delivered via an app. Symptom severity interviews will be conducted at baseline; mid-intervention (4 weeks after the intervention begins); end of intervention; and at 6, 9, and 15 months post-baseline by phone or videoconference. Self-rated symptom severity and quality of life data will be gathered at those timepoints, as well as at 16 weeks post baseline. To provide a more refined index of whether TRE successfully decreases emotional lability and improves sleep, participants will be asked to complete a sleep diary (core CSD) each morning and complete six mood assessments per day for eight days at baseline and again at mid-intervention. Discussion: The planned research will provide novel and important information on whether TRE is more beneficial than the Mediterranean diet for reducing mood symptoms and improving quality of life in individuals with BD who also experience sleep or circadian problems. Trial registration: ClinicalTrials.gov ID NCT06188754. [ABSTRACT FROM AUTHOR]

Purpose: To investigate fluid absorption and its influencing factors during flexible ureteroscopy with intelligent control of renal pelvic pressure (RPP). Methods: A total of 80 patients with upper urinary tract calculi underwent flexible ureteroscopy with intelligent control of RPP by pressure-measuring ureteral access sheath and were randomly divided into four groups. The RPP of Groups A, B, and C were set at – 5, 0 and 5 mmHg, respectively. Conventional flexible ureteroscopy with uncontrolled pressure served as control Group D. The perfusion flow rate was set at 100 ml/min in the four groups, with 20 patients in each group. The fluid absorption was measured by 1% ethanol every 10 min. Operation time, stone-free rate, and complications were recorded. Result: Seventy-three patients were finally included in the RCT. The general and preoperative data of the patients were comparable between the groups. The fluid absorption of Groups A, B, and C was significantly less than that of Group D (P < 0.01). Fluid absorption and operation time were positively correlated, and the correlation coefficients R were 0.864, 0.896, 0.918, and 0.947, respectively (P < 0.01). The fluid absorption of patients with vomiting, fever and ureteral injury was greater than that of patients without complications in the four groups (P < 0.01). In different groups, fluid absorption was greater in patients with ureteral injury Post-Ureteroscopic Lesion Scale (PULS) 1–3 than in noninjured patients (P < 0.01). Conclusion: Flexible ureteroscopy with intelligent control of RPP effectively reduces the absorption of perfusion fluid. Operation time and ureteral injury are also key factors affecting perfusion fluid absorption. Registration number and date: NCT05201599; August 11, 2021. [ABSTRACT FROM AUTHOR]

Introduction: Childhood cancer survivors (CCS) are at risk of experiencing lower quality-of-life, fatigue, and depression. Few randomized controlled trials have studied the effect of physical activity (PA) on these in adult long-term CCS. This study investigated the effect of a 1-year individualized PA intervention on healthrelated quality-of-life (HRQOL), fatigue, and distress symptoms in adult CCS. Methods: The SURfit trial randomized 151 CCS =16 years old, <16 at diagnosis and =5 years since diagnosis, identified through the Swiss Childhood Cancer Registry. Intervention participants received personalized PA counselling to increase intense PA by =2.5 h/week for 1 year. Controls maintained usual PA levels. The authors assessed physical- and mental-HRQOL, fatigue, and distress symptoms at baseline, 3, 6, and 12 months. T-scores were calculated using representative normative populations (mean = 50, standard deviation = 10). Generalized linear mixed-effects models with intention-to-treat (ITT, primary), and three per-protocol allocations were used. Results: At 12 months, ITT (-3.56 larger decrease, 95% confidence interval -5.69 to -1.43, p = .001) and two per-protocol analyses found significantly lower fatigue. Physical-HRQOL improved significantly in two per-protocol analyses at 12 months. No other effects were found. Conclusion: SURfit showed that increased intense PA over 1 year improved fatigue in adult CCS. Survivors should be recommended PA to reduce the burden of late-effects. [ABSTRACT FROM AUTHOR]

Introduction: We assessed the impact of a personal agency-based training for refugee women and their male partners on their economic and social empowerment, rates of intimate partner violence (IPV), and non-partner violence (NPV). Methods: We conducted an individually randomized controlled trial with 1061 partnered women (aged 18–45) living in a refugee camp in Rwanda. Women received two days of training, and their partners received one day of training. The follow-up survey where all relevant outcomes were assessed was carried out at 6–9 months post-intervention. Results: At follow up, women in the intervention arm were more likely to report partaking in income generating activities (aIRR 1.27 (1.04–1.54), p < 0.05) and skill learning (aIRR 1.59 (1.39–1.82), p < 0.001) and reported a reduction in experience of physical or sexual NPV in the past six months (aIRR 0.65 (0.39–1.07), p < 0.09). While improved, no statistically significant impacts were seen on physical or sexual IPV (aIRR 0.80 (0.58–1.09), p = 0.16), food insecurity (β 0.98 (0.93 to 1.03), p = 0.396), or clean cookstove uptake (aIRR 0.95 (0.88 to 1.01), p = 0.113) in the past six months. We found statistically significant reduction in physical and sexual IPV amongst those experiencing IPV at baseline (aIRR 0.72 (0.50 to 1.02), p < 0.07). Small improvements in self-efficacy scores and our indicator of adapting to stress were seen in the intervention arm. Some challenges were also seen, such as higher prevalence of probable depression and/or anxiety (aIRR 1.79 (1.00-3.22), p = 0.05) and PTSD (aIRR 2.07 (1.10–3.91), p < 0.05) in the intervention arm compared to the control arm. Conclusion: Our findings echo previous research showing personal agency training can support economic well-being of women. We also find potentially promising impacts on gender-based violence. However, there is some evidence that integration of evidence-based mental health support is important when enhancing agency amongst conflict-affected populations. Trial registration number: The trial was registered with ClinicalTrials.gov, Identifier: NCT04081441 on 09/09/2019. Key message: What is known? • There are limited impacts of economic interventions in humanitarian settings on gender-based violence. • Outside of humanitarian settings, agency-based training interventions, both with/or without male partner engagement, have been shown to improve economic impacts, however IPV impacts are not known. • Integrated multi-component interventions that economically empower women and engage male partners hold promise in conflict-affected populations. What are the new findings? • An abbreviated two-day personal agency training for women and one-day training for their male partners led to significant increases in uptake of income generating activities and skill building for women. • Promising trends suggest reduction in non-partner violence for the full study sample and a reduction in intimate partner violence for women who reported IPV at baseline. • Increased rates of probable anxiety and/or depression and post-traumatic stress disorder (PTSD) were identified in the intervention group. What do the new findings imply? • Promising impacts on livelihoods and experience of violence are possible despite the abbreviated nature of this training. • Despite improvements in livelihoods and reduction in experience of violence, more concerted efforts are needed to prevent the increased risk of anxiety, depression, and PTSD found in conflict-affected populations. [ABSTRACT FROM AUTHOR]

Simple Summary: This study investigated whether using virtual reality (VR) could help reduce anxiety in women undergoing gynecological cancer surgery. Participants were split into two groups: one receiving VR therapy alongside usual care and the other receiving only usual care. Results showed that VR significantly decreased anxiety levels before surgery compared to the control group. This suggests that VR could be a valuable tool in preparing patients for surgery, potentially improving their experience and outcomes. Further research is needed to explore VR's benefits in other types of surgery and its long-term effects on patient recovery. Perioperative anxiety is common among patients undergoing surgery, potentially leading to negative outcomes. Immersive virtual reality (VR) has shown promise in reducing anxiety in various clinical settings. This study aimed to evaluate the effectiveness of VR in reducing perioperative anxiety in patients undergoing gynecological oncology surgery and was conducted as a single-center, double-arm, single-blinded randomized controlled trial at the Gold Coast University Hospital, Queensland, Australia. Participants were randomized into the VR intervention + care as usual (CAU) group (n = 39) and the CAU group (n = 41). Anxiety scores were assessed using a six-tier visual facial anxiety scale at baseline, after the intervention/CAU on the same day, and, several days up to weeks later, immediately before surgery. There was no significant difference in baseline anxiety scores, type of operation, or suspected cancer between the two groups. The VR intervention significantly reduced anxiety scores from baseline to preoperative assessment (p < 0.001). The median anxiety score in the VR intervention group decreased from 3 (interquartile range 2 to 5) at baseline to 2 (2 to 3) prior to surgery, while the control group's scores were 4 (2 to 5) and 4 (3 to 5), respectively. Multivariate analysis showed that group assignment was the sole outcome predictor, not age, type of procedure, or the time elapsed until surgery. Thus, VR exposure was effective in reducing perioperative anxiety in patients undergoing gynecological oncology surgery. The use of VR as a preparation tool may improve patient experience and contribute to better surgical outcomes, warranting further research into exploring the potential benefits of VR in other surgical specialties and its long-term impact on patient recovery. [ABSTRACT FROM AUTHOR]

Background Among individuals with vitamin D deficiency, daily vitamin D supplementation appears to lower risk of acute respiratory infection. However, recent trials, in different populations and using different regimens, have yielded null results. We investigated the effect of daily vitamin D supplementation (vs placebo) on risk of upper respiratory infection (URI) in older adults. Methods The VITamin D and OmegA-3 TriaL (VITAL) is a randomized, double-blind, placebo-controlled trial of supplemental vitamin D and/or omega-3 fatty acids in generally healthy men (age ≥50 years) and women (age ≥55 years). This prespecified analysis focuses on vitamin D3 (2000 IU/day) versus placebo in the 15 804 (61%) participants with baseline serum total 25-hydroxyvitamin D level. The primary outcome was self-report of a recent URI at 1-year follow-up. Results Participants had a mean age of 68 years and 51% were women; 76% were non-Hispanic White, 16% Black, and 8% other race/ethnicity. The mean 25-hydroxyvitamin D level at baseline was 31 (standard deviation, 10) ng/mL, with <12 ng/mL in 2.4%. The overall effect of vitamin D supplementation on recent URI was nonsignificant (odds ratio [OR], 0.96 [95% confidence interval {CI},.86–1.06]). In the prespecified subgroup of primary interest (<12 ng/mL and denied taking concurrent vitamin D), which had only 255 participants, vitamin D supplementation was nonsignificant (OR, 0.60 [95% CI,.28–1.30]). Statistical power to assess effect modification in other subgroups was limited. Conclusions In older adults not selected for vitamin D deficiency, supplemental vitamin D did not lower URI risk overall. Whether effects differ in subgroups requires further study. Clinical Trials Registration. NCT01169259. [ABSTRACT FROM AUTHOR]

Objectives: To explore the effects of a 'Rebuilding Myself' intervention on enhancing the adaptability of cancer patients to return to work. Methods: A single-center, single-blind, randomized controlled trial design was used. Eligible patients who were receiving routine hospital treatment were recruited from the university-affiliated hospital in our city. Patients in the control group only received usual care, while patients in the intervention group received additional 'Rebuilding Myself' intervention. Adaptability to return to work, self-efficacy of returning to work, mental resilience, quality of life and work ability were measured at baseline, the 6th and 12th of the intervention. The general estimation equations were used to compare the overall changes of each outcome index between the two groups at different time points. Considering that there may be patient shedding and rejection, Per-Protocol and Intention-to-Treat analysis were used to analyze the data in this study. Results: There were statistically significant differences between the two groups of patients in the cancer patients' adaptability to return to work, self-efficacy to return to work, mental resilience, work abilities, the physical, emotional, cognitive function, fatigue, insomnia and overall health status dimensions of quality of life (P < 0.05). And no significant difference was found in other dimensions (P > 0.05). The group effect, time effect, and interaction effect of patients' return to work adaptability and return to work self-efficacy were statistically significant in both groups (P < 0.05). Mental resilience, working ability, and quality of life had obvious time effect and interaction effect (P < 0.05). Conclusion: This intervention could improve cancer patients' adaptability to return to work, self-efficacy to return to work, mental resilience, work abilities and quality of life. And it can be further expanded to improve the adaptability of patients to return to work, then to help patients achieve comprehensive rehabilitation. Implications for cancer survivors: The application of 'Rebuilding Myself' interventions can effectively improve the adaptability of cancer patients returning to work. Trial registration: This study was registered at the Chinese Clinical Trial Registry (Registration number: ChiCTR2200057943) on 23 March, 2022. [ABSTRACT FROM AUTHOR]

Background: Inositol is a potential new therapeutic agent for gestational diabetes mellitus (GDM), but its effectiveness is still controversial. The aim of the report was to evaluate the effectiveness of inositol to preventing or reducing the severity of GDM. Methods: We searched PubMed, EmBase, Web of science, Cochrane library databases, Clinicaltrials.gov, and International Clinical Trials Registry Platform for randomized controlled trials (RCTs) assessing the effectiveness of inositol supplementation to prevent and treat GDM. This meta-analysis was performed using the random-effects model. Results: A total of 7 RCTs (1319 pregnant women at high risk of GDM) were included in the meta-analysis. The meta-analysis found that inositol supplementation resulted in a significantly lower incidence of GDM in the inositol versus the control group (odds ratio [OR] 0.40; 95% confidence interval [CI] 0.24–0.67; P = 0.0005). The inositol group had improved fasting glucose oral glucose tolerance test (FG OGTT; mean difference [MD] = − 3.20; 95% CI − 4.45 to − 1.95; P < 0.00001), 1-h OGTT (MD = − 7.24; 95% CI − 12.23 to − 2.25; P = 0.004), and 2-h OGTT (MD = − 7.15; 95% CI − 12.86 to − 1.44; P = 0.01) results. Inositol also reduced the risk of pregnancy-induced hypertension (OR 0.37; 95% CI 0.18–0.75; P = 0.006) and preterm birth (OR 0.35; 95% CI 0.18–0.69; P = 0.003). A meta-analysis of 4 RCTs including 320 GDM patients showed that the patients' insulin resistance (P < 0.05) and neonatal hypoglycemia risk (OR 0.10, 95% CI 0.01–0.88; P = 0.04) were lower in the inositol than in the control group. Conclusions: Inositol supplementation during pregnancy has the potential to prevent GDM, improve glycemic control, and reduce preterm birth rates. [ABSTRACT FROM AUTHOR]

Parenting programs have been shown to empower parents and prevent mental health problems in children. However, few programs are designed to promote wellbeing, which led to the development of the Swedish-promotive universal program, "All Children in Focus" (ACF). This study aimed to understand the effects of parents' participation in the ACF program on parents' emotion regulation and parenting practices over a 6-month follow-up and if intervention-produced changes predict child wellbeing (CW). Parental self-efficacy (PSE) was also included to assess the relation with parental outcomes and CW. This is an evaluation of a multicenter randomized waitlisted control trial conducted in Stockholm County, Sweden, with parents of children aged 3 to 12 years (n = 621) in 2012. Parents were randomized 1:1 to enter the program or to a waitlist. Questionnaires were completed by parents at baseline, post-intervention, and 6 months post-baseline. We used generalized mixed modeling to test effects on parental outcomes over time and regression analyses to study the predictive role of parental outcomes on CW. From baseline to the post- and to the 6-month follow-ups, parents in the intervention group reported greater levels of emotion regulation skills, cognitive reappraisal, and positive parenting than did parents in the control group. A decrease in negative and harsh parenting was evident in both groups, although it was greater in the intervention group. An increase in PSE was associated with high negative parenting at baseline in the intervention group. Child gender moderated positive parenting, suggesting that parents of girls in the intervention group had more favorable development of positive strategies. The findings indicate that a change in PSE predicts a change in CW at 6 months. The ACF program can be used to strengthen and develop parenting. This study advances our knowledge about the potential advantages of using a health-promoting approach to strengthen the wellbeing of families in the general population. Clinical trial registration: ISRCTN70202532 Current Controlled Trials [ABSTRACT FROM AUTHOR]

Using a randomized controlled trial, we investigated changes in both sexual harassment (SH) perpetration and victimization of 2104 middle school students in New York City who received divergent saturation and dosage levels of Shifting Boundaries, an SH prevention program, which was represented by the length of the program. We assessed the saturation effect of the program by comparing the outcomes across respondents from 26 schools in which there were varying percentages of students enrolled in the program. The data suggested that, overall, the program was effective in reducing sexual harassment victimization but achieved a null effect against respondents' SH perpetration and that neither the length nor the school-saturation level of the program exerted a significant effect on SH perpetration. Although the data indicated a significant difference in SH victimization between the treatment and control group, when comparing subgroups who received treatment with divergent saturation and dosage levels, no statistically significant difference was identified. Our results suggested that the program effect was not contingent on the portion of students in a school who enrolled in the program, nor was it contingent on the dosage. [ABSTRACT FROM AUTHOR]

Smoking is the single factor with the highest impact on reducing life expectancy of patients with mental illness. Patients experience difficulty in participating in smoking cessation programs but are concerned about the impact of tobacco on their health and finances. Smoking cessation advice via videoconferencing might be an alternative to an ordinary in-person consultation. Randomized controlled trial with follow-up at 6 months. We included patients with diagnoses of schizophrenia and affective disorder from psychiatric outpatient clinics. Intervention 1 involved daily video consultations; intervention 2 was treatment as usual. Seventy patients were included. For both/all groups/interventions, rates of smoking cessation were 45% and predictors for a 50% reduction in smoking were antipsychotic medication load [odds ratio (OR) 0.54; p = 0.045] and number of nicotine patches (OR 1.02; p = 0.06). Predictors for a reduction in the number of cigarettes to < 10 were antipsychotic medication load (OR 0.52; p = 0.04), number of nicotine patches (OR 1.01; p = 0.02) and number of cigarettes at baseline [OR 0.95 (p = 0.09); adjusted OR 0.94 (p = 0.02)]. Patients prevented weight gain during the cessation period. The smoking cessation rate was high. One of the reasons for the high cessation rate was that the intervention was carried out by highly experienced and professionally qualified staff. In addition, we used free nicotine patches to increase the patients' motivation to quit smoking. It is very important that we introduce these results into our clinical work with the patients. [ABSTRACT FROM AUTHOR]

Purpose: Depressive symptoms are prevalent among Chinese adolescents. However, there is a lack of effective prevention programs to reduce depressive symptoms. Methods: A pilot cluster randomized controlled trial was implemented in a sample of senior secondary school adolescents. Participants in the intervention group (N = 148) received a 6-week universal prevention course, whereas the control group (N = 131) received a routine course focusing on career development. Results: The linear mixed models showed that the group × time interaction was significant for depressive symptoms measured by DASS-21 (F (2, 550) = 5.72, p =.003) and marginally significant for that measured by SMFQ (F (2, 549) = 2.41, p =.09). Likewise, the level of anxiety and stress were significantly reduced after the program, but not maintained in the follow-up. Conclusions: This pilot study showed that a universal prevention program is promising in reducing adolescent depressive symptoms. [ABSTRACT FROM AUTHOR]

Background:Patients suffering from incurable diseases are more likely to die in the hospital than at home. Specialized outpatient palliative care (PC) may be able to counteract this tendency. Similarly, potential benefits of telemedicine in health care were scientifically reported. The aim of this research was to compare patients receiving specialized outpatient PC plus telemedicine with those receiving standard specialized outpatient PC only. In this study, telemedicine is assumed to decrease the number of home visits and therefore should not be considered a mere add-on. Methods:This is a randomized controlled noninferiority trial. Recruitment lasted between January 2020 and October 2021. Quality of care was evaluated using the Integrated Palliative Care Outcome Scale (IPOS) at day 0, 7, and 14 after randomization. Change from day 0 to 7 was defined as the primary outcome (noninferiority margin = 4 points). This study was conducted in an urban setting in collaboration with a university hospital and a local specialized outpatient PC service. Results:A total of 196 patients were screened with 34 patients included (18 telemedicine/16 standard care). The mean change in the total score of the IPOS from day 0 to 7 amounted to −1.8 ± 3.9 (telemedicine) versus 1.2 ± 5.7 (standard care). The telemedicine group was statistically not relevantly inferior to the standard care group (t-test for noninferiority, p = 0.005). Conclusions:Although, due to COVID-19, the sample size remained rather small, our findings indicate that telemedical approaches offer a promising and equally effective option to provide specialized outpatient PC. Clinical Trial Registration Number: NCT06054048. [ABSTRACT FROM AUTHOR]

University students were at an increased risk for psychological distress during the COVID-19 pandemic. Using a randomized controlled trial, we examined the efficacy of an online Kundalini Yoga intervention on students' psychological functioning. Healthy university students (N = 106) were randomly assigned to a Kundalini Yoga group, an active control group, or a passive control group in a 1:1:1 ratio. The experimental group attended six Yoga sessions over 6 weeks and the active control group attended to six autogenic relaxation sessions over 6 weeks. All participants completed the study protocol, which involved answering questionnaires related to psychological distress, emotion regulation, self-compassion, self-concept, spiritual well-being, and subjective happiness at three different time points: baseline, at the end of the intervention, and at 1-month follow-up. Results showed that Yoga contributed to improving self-compassion, extrinsic affect improving, and personal and communal spiritual well-being, in comparison to the control groups. [ABSTRACT FROM AUTHOR]

The pathophysiology and the potential risks of placental transfusion (PT) differ substantially in preterm infants, necessitating specific studies in this population. This study aimed to evaluate the safety and efficacy of PT in preterm infants from the perspective of long-term neurodevelopmental outcomes. We conducted a systematic literature search using placental transfusion, preterm infant, and its synonyms as search terms. Cochrane Central Register of Controlled Trials, Medline, and Embase were searched until March 07, 2023. Two reviewers independently identified, extracted relevant randomized controlled trials, and appraised the risk of bias. The extracted studies were included in the meta-analysis of long-term neurodevelopmental clinical outcomes using fixed-effects models. A total of 5612 articles were identified, and seven randomized controlled trials involving 2551 infants were included in our meta-analysis. Compared with immediate cord clamping (ICC), PT may not impact adverse neurodevelopment events. No clear evidence was found of a difference in the risk of neurodevelopmental impairment (risk ratio [RR]: 0.89, 95% confidence interval [CI]: 0.76 to 1.03, P = 0.13, I2 = 0). PT was not associated with the incidence of cerebral palsy (RR: 1.23, 95% CI: 0.59 to 2.57, P = 0.79, I2 = 0). Analyses showed no differences between the two interventions in cognitive, language, and motor domains of neurodevelopment. From the perspective of long-term neurodevelopment, PT at preterm birth may be as safe as ICC. Future studies should focus on standardized, high-quality clinical trials and individual participant data to optimize cord management strategies for preterm infants after birth. [ABSTRACT FROM AUTHOR]

Background and aims: Despite the high prevalence and negative effects of hazardous substance use, few young adults enter treatment. Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, has proved efficacious in promoting treatment entry. The aim of the current trial was to compare the efficacy of CRAFT with an active control for parents of young adults (aged 18–24 years) with hazardous substance use. Design: This was a randomized controlled superiority trial comparing CRAFT (n = 58) with an active control group receiving manualized counselling (n = 55), with outcome assessments at 6, 12 and 24 weeks (primary end‐point). A sequential design with a stopping rule was added post recruitment commencement. Setting: The study took place in two outpatient clinics for young adults in Stockholm, Sweden, and subsequently via video‐conference due to COVID‐19. Participants: Between October 2018 and May 2021, 113 participants (92% female) who were parents of young adults (87% male) were recruited. Recruitment was discontinued when 70% of the planned sample had been recruited, following an interim analysis of the primary outcome showing no difference between conditions. Intervention and comparator: Participants were randomized (ratio 1 : 1) to eight manual‐based individual CRAFT sessions or five individual manual‐based counselling sessions + one voluntary psychoeducative group session, delivered over maximum 14 weeks. Measurements The primary outcome measure was the rate of young adult entry in substance use treatment during the trial period (24 weeks). Findings At the 24 weeks follow‐up, 19 (33%) of CRAFT participants and 17 (31%) of counselling participants had reported young adult treatment entry, with no difference between conditions (odds ratio CRAFT versus counselling 0.84, 95% confidence interval = 0.35; 1.99, P = 0.700). Both conditions reported clinically relevant reductions in young adult substance use, but no change in participants' levels of depression, anxiety or stress. Conclusions: This trial showed no statistically significant evidence that Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, is more efficacious than manual‐based counselling regarding treatment entry for young adults. [ABSTRACT FROM AUTHOR]

Background: Hand eczema (HE) is a common and heterogeneous condition. It has a wide range of etiologies and clinical manifestations. In this study the efficacy of triamcinolone 0.1% cream and sulfur 2% creams was compared in treating patients with HE. Methods: This randomized, triple‐blind clinical trial was performed on 70 patients with HE (including 70 right and 70 left hands). In this study, two creams were used including triamcinolone 0.1% and sulfur 2.0%. Patients were treated with these creams twice a day (once in every 12 h) for 4 weeks. Follow‐up was 4 weeks after treatment. Hand Eczema Severity Index (HECSI), itching, dryness, burning sensation, and erythema scores were collected three times during the study and compared between treatment regimens. Results: Findings showed that both triamcinolone (0.1%) and sulfur (2.0%) creams could significantly reduce the scores of HECSI, itching, dryness, burning sensation, and erythema, and the therapeutic effects lasted for at least 4 weeks after cessation of topical treatment. Conclusion: Topical sulfur cream (2.0%) is as effective as triamcinolone (0.1%) cream in treatment of HE without any prominent adverse reactions. [ABSTRACT FROM AUTHOR]

Simple Summary: Head and neck cancer is associated with significant morbidity. Shoulder and neck dysfunction, weight loss, and declines in muscular strength and physical functioning are commonly seen following cancer therapies. This pragmatic randomized controlled trial involved sixty-one individuals with cancer in the head and neck region who had completed their cancer treatment. The primary aim was to assess the effectiveness of the addition of lower-body resistance exercise training to a physiotherapeutic shoulder and neck exercise protocol on fatigue-related quality of life. Findings support the benefit of the combined intervention for fatigue-related quality of life, six-minute walk test distance, upper- and lower-body muscular strength, and physical activity level. The continued improvement in treatment effect over the one-year follow-up period suggests promise from this interdisciplinary approach to bridge individuals with head and neck cancer from rehabilitation care to general exercise and physical activity. Background: Established barriers to general exercise and physical activity among individuals with head and neck cancer include dry mouth, difficulty eating, weight loss, fear of injury, comorbidities, and treatment-related symptoms of pain and fatigue. Methods/Design: A 12-week pragmatic randomized controlled trial was conducted followed by an optional supported exercise transition phase. Eligible participants were individuals with head and neck cancers who had undergone surgery and/or radiation therapy to lymph node regions in the neck. Participants were randomized to a comparison group involving a shoulder and neck physiotherapeutic exercise protocol, or to a combined experimental group comprising the shoulder and neck physiotherapeutic exercise protocol and lower-body resistance exercise training. The primary outcome of this study was fatigue-related quality of life. Results: Sixty-one participants enrolled, 59 (97%) completed the randomized trial phase, 55 (90%) completed the 24-week follow-up, and 52 (85%) completed the one-year follow-up. Statistically significant between-group differences were found in favor of the combined experimental group for the fatigue-related quality of life, fitness outcomes, and overall physical activity. Paired comparisons confirmed significant within-group improvements for both groups from baseline to one-year follow-up across most outcomes. Discussion: A group-based combined physiotherapeutic and lower-body resistance exercise program was feasible and effective. Findings are limited to individuals who had undergone a surgical neck dissection procedure. Given the complexity of head and neck cancer, further pragmatic interdisciplinary research is warranted. [ABSTRACT FROM AUTHOR]

Objective: Our ability to predict responsiveness to digital interventions for eating disorders has thus far been poor, potentially for three reasons: (1) there has been a narrow set of predictors explored; (2) prediction has mostly focused on symptom change, ignoring other aspects of the user journey (uptake, early engagement); and (3) there is an excessive focus on the unique effects of predictors rather than the combined contributions of a predictor set. We evaluated the univariate and multivariate effects of outcome predictors in the context of a randomized trial (n = 398) of digitally delivered interventions for recurrent binge eating. Method: Thirty baseline variables were selected as predictors, ranging from specific symptoms, to key protective factors, to technological acceptance, and to online treatment attitudes. Outcomes included uptake, early engagement, and remission. Univariate (d) and multivariate (D) standardized mean differences were calculated to estimate the individual and combined effects of predictors, respectively. Results: At the univariate level, few predictors produced an effect size larger than what is considered small (d >.20) across outcomes. However, our multivariate approach enhanced prediction (Ds =.65 to 1.12), producing accuracy rates greater than chance (63%–71% accuracy). Less than half of the chosen variables proved to be useful in contributing to predictions in multivariate models. Conclusion: Findings suggest that accuracy in outcome prediction from digitally delivered interventions may be better driven by the aggregation of many small effects rather than one or several largely influential predictors. Replication with different data streams (sensor, neuroimaging) would be useful. Public Significance: Our ability to predict who will and will not benefit from digital interventions for eating disorders has been poor. We highlight the viability of a multivariate approach to outcome prediction, whereby prediction may be better driven by the aggregation of many small effects rather than one or a few influential predictors. [ABSTRACT FROM AUTHOR]

To compare the analgesic efficacy and adverse events of proximal versus distal ACB for adults undergoing knee arthroplasty, we searched PubMed, Cochrane, Web of Science, and Embase to identify all eligible randomized controlled trials (RCTs). The study quality of the RCTs was evaluated using the Cochrane risk of bias assessment tool. Heterogeneity among studies was examined by Cochrane Q test. Our primary outcomes were pain intensity at rest/during movement and morphine consumption. Statistical analyses were conducted by RevMan Software. Seven eligible studies involving 400 subjects were included in this meta‐analysis with 202 participants in the proximal ACB group and 198 participants in the distal ACB group. The results demonstrated that proximal ACB provided significantly better pain relief at rest at 2 h (SMD −0.27, 95% CI −0.54 to −0.01, four trials, 222 participants, I2 = 0, p = 0.04) and 24 h (SMD −0.28, 95% CI −0.48 to −0.08, seven trials, 400 participants, I2 = 0, p = 0.006) following the surgery. We found no evidence of a difference in postoperative pain intensity at other timepoints. Furthermore, we noted no evidence of a difference in cumulative morphine consumption and occurrence of adverse events. Proximal ACB provides better pain relief and comparable adverse effects profile compared with distal ACB. The analgesic benefit offered by proximal ACB, however, did not appear to extend beyond the first 24 h. The overall evidence level was mostly low or very low, which requires more well‐organized multicenter randomized trials in the future. [ABSTRACT FROM AUTHOR]

Objective To determine the efficacy of micro-needle knife therapy versus placebo (sham microneedle knife) for cervicogenic headache. Method A total of 60 eligible patients with cervicogenic headache were assigned to two groups with 30 cases in each group by using a random number table. Treatment group received micro-needle knife therapy and placebo group received sham micro-needle knife. Results After 4 weeks of intervention, the pain index score was significantly lower in the treatment group (1.27 ± 0.583) than that of the placebo group (3.37 ± 0.765); the cervical range of motion was significantly lower in the treatment group A (1.20 ± 0.407) than that of the placebo group (2.47 ± 0.681); the headache duration was significantly lower in the treatment group (3.33 ± 0.661) than that of the placebo group (5.30 ± 0.988); the headache frequency was significantly lower in the treatment group (1.50 ± 0.682) than that of the placebo group (2.73 ± 0.691), and the differences in the data of the two groups were statistically significant. The duration of headache (3.93 ± 0.739) and frequency of headache (1.96 ± 0.556) were significantly lower in the treatment group than that of the placebo group at follow-up, and the difference was statistically significant (P < 0.05). The occurrence of adverse reactions was not statistically significant in the two groups (P > 0.05) Conclusions Micro-needle knife therapy could effectively improve the pain level of cervicogenic headache patients, reduce the headache duration and headache frequency, and improve the mobility of cervical spine. Acupuncture-related adverse events during treatment were infrequent in both groups and it's safe for cervicogenic headache. [ABSTRACT FROM AUTHOR]