Subgroup Of Participants Research Articles

Leu72Met Polymorphism in Ghrelin Gene: A Potential Risk Factor for Hypertension in Type 2 Diabetes Patients.

Ghrelin (GHRL) is known to be engaged in metabolic and cardiovascular processes. There is evidence suggesting its involvement in the regulation of blood pressure and hypertension. The purpose of this preliminary case-control study was to determine the involvement of the Leu72Met (rs696217) polymorphism in the GHRL gene in type 2 diabetes (T2DM). The Leu72Met polymorphism was genotyped in 820 individuals with T2DM and 400 healthy subjects by the PCR-RFLP technique. The polymorphism distribution was first compared in those withT2DM and controls, then in subgroups of participants representing different clinical phenotypes. No significant association was identified between Leu72Met and T2DM. The distribution of polymorphism was analyzed in subgroups of individuals with different clinical phenotypes (hypertension, diabetic nephropathy, obesity). In this analysis, rs696217 was associated with hypertension. The presence of T allele was associated with higher risk of hypertension (OR = 2.50, 95% CI 1.68-3.73, p < 0.001). When adjusted for age, gender and BMI, the association was still significant (OR = 2.62, 95% CI 1.83-3.96, p < 0.001). A post hoc power calculations based on a minor allele frequency revealed the power of 97% for comparison between HY+ and HY- subgroups. This is the first study demonstrating that the ghrelin Leu72Met SNP is associated with hypertension in Caucasians with T2DM. If confirmed in larger studies in different populations, it may be a novel potential risk factor for hypertension in individuals withT2DM.

The efficacy of applying the Interpersonal Effectiveness skills of dialectical behavior therapy into communication skills workshop for clinical nurses

BackgroundWe designed this open-pilot study to investigate the efficacy and feasibility of incorporating the Interpersonal Effectiveness skills from Dialectical Behavior Therapy (DBT-IE) into a 3-h clinical communication workshop for registered nurses. MethodA convenience sample of registered nurses were invited. The Professional Fulfillment Index, Perceived Stress Scale, Empathy Index, the Interpersonal Reactivity Index, and measures regarding quality of life, anxiety, depression, and insomnia were completed. A subgroup of participants received the Objective Structured Teaching Examinations (OSTE). Pre- and post-workshop assessments were conducted to identify the most empathetic or validated responses from case scenarios and to assess the self-rated levels of confidence regarding the capability to select the best answer. The satisfaction of the participants with respect to the workshop content, process, and the lecturer were also collected. Paired t-test was used for statistical analysis. ResultsAmong the 164 participants of the clinical communication workshop, 72 consented and their pre- and post-results were analyzed. Post-workshop assessment revealed significant improvement in professional fulfillment (p = 0.014), interpersonal coping ability (p = 0.038), and decrease in dysfunctional coping style (p < 0.001). The overall satisfaction score of participants was 4.68 (5-point Likert scale). In the subgroup that underwent pre- and post-workshop OSTE (n = 28), there was a significant improvement in total scores, pass rates, ratings from observational supervisors, simulated students, and simulated patients after the workshop (p < 0.001). ConclusionOur results demonstrated the effectiveness, acceptance, and feasibility of incorporating the DBT-IE skills into a clinical medical communication workshop through a teaching style comprising of rigorous interactions and hands-on practices.

Hearing Healthcare Professionals' Views about Over-The-Counter (OTC) Hearing Aids: Analysis of Retrospective Survey Data.

Over-the-counter hearing aids have been available to consumers in the US since 17 October 2022 following a ruling by the Food and Drug Administration. However, their reception by hearing healthcare professionals (HHP) has been mixed, and concerns have been expressed by many HHPs. The aim of this study was to examine the concerns that HHPs have towards over-the-counter (OTC) hearing aids. The study used a retrospective survey design. The survey data of HHPs (n = 730) was obtained from Hearing Tracker. A 22-item structured questionnaire was administered using a Question Scout platform. Descriptive analyses examined reported areas of concern and a Fisher's exact test examined the relationship between demographics and responses. A cluster analysis with partitioning around medoids (PAM) was used to identify a sub-group of participants based on responses. Nearly half of HHPs who participated reported that they will support patients with OTC hearing aids purchased elsewhere, whereas a quarter reported that they will sell OTC hearing aids in their clinic or website. HHPs expressed over 70% agreement in 'concern' statements in 14 of the 17 items. Issues about safety, counseling, and audiological care were the key concerns expressed by HHPs about OTC hearing aids. Some demographics (i.e., profession, primary position) were associated with responses to some statements. Two groups were identified based on the responses to concern statements. The HHPs in the first cluster 'OTC averse' (51%) agreed on all the 17 concern statements, whereas the second cluster 'OTC apprehensive' (49%) had some items rated as disagree (i.e., consumers will give up on amplification) and neither agree nor disagree (i.e., do not provide good value, warranties and return periods will be worse), and remaining items were rated as agree. OTC hearing aids were initiated to improve affordability, accessibility, and hearing aid uptake and are currently a rapidly emerging category of hearing devices. Overall, the results of the current study indicate that HHPs have serious concerns about OTC hearing aids. HHP concerns cited in this study provide useful feedback to stakeholders (e.g., HHP professional agencies, FDA, industry, and insurance payers) involved in improving OTC hearing aid implementation.

Patient Satisfaction With Medical Care for Chronic Low Back Pain: A Pain Research Registry Study.

The process and outcomes of delivering medical care for chronic low back pain might affect patient satisfaction. We aimed to determine the associations of process and outcomes with patient satisfaction. We conducted a cross-sectional study of patient satisfaction among adult participants with chronic low back pain in a national pain research registry using self-reported measures of physician communication, physician empathy, current physician opioid prescribing for low back pain, and outcomes pertaining to pain intensity, physical function, and health-related quality of life. We used simple and multiple linear regression models to measure factors associated with patient satisfaction, including a subgroup of participants having both chronic low back pain and the same treating physician for >5 years. Among 1,352 participants, only physician empathy (standardized β, 0.638; 95% CI, 0.588-0.688; t = 25.14; P < .001) and physician communication (standardized β, 0.182; 95% CI, 0.133-0.232; t = 7.22; P < .001) were associated with patient satisfaction in the multivariable analysis that controlled for potential confounders. Similarly, in the subgroup of 355 participants, physician empathy (standardized β, 0.633; 95% CI, 0.529-0.737; t = 11.95; P < .001) and physician communication (standardized β, 0.208; 95% CI, 0.105-0.311; t = 3.96; P < .001) remained associated with patient satisfaction in the multivariable analysis. Process measures, notably physician empathy and physician communication, were strongly associated with patient satisfaction with medical care for chronic low back pain. Our findings support the view that patients with chronic pain highly value physicians who are empathic and who make efforts to more clearly communicate treatment plans and expectations.

Abstract P396: A Culturally Tailored Mobile Health Lifestyle Intervention Improves Cardiovascular Health Among African Americans With Preexisting Risk Factors

Background: African-American (AA) adults have a higher prevalence of cardiovascular (CV) risk factors, leading to higher CV disease mortality than White adults. Prior findings of our mobile health (mHealth) lifestyle intervention (FAITH! App) demonstrated efficacy in promoting ideal cardiovascular health (CVH) in AAs. Hypothesis: We hypothesized that the intervention group with preexisting CV risk factors would have a greater increase in LS7 scores than the control group with the same risk factors following use of the FAITH! App. Methods: A cluster randomized controlled trial was conducted among AAs from 16 churches in Minnesota. The intervention included culturally relevant, LS7-focused education modules, diet/physical activity self-monitoring and a group sharing board. A subgroup of participants with ≥1 diagnosis of overweight/obesity, hyperlipidemia, hypertension (HTN) or diabetes was examined. The primary outcome was change in LS7 score—a measure of CVH ranging from poor to ideal (range 0-14 points)—at 6 months post-intervention. Results: Forty-nine participants (75.5% female) were included in the intervention (n=20; mean age [SD]: 58.8 [9.5]) or control (n=29, mean age [SD]: 52.5 [10.7]) groups (Table 1). There was no significant difference in the CV risk factor prevalence between the two groups. There was a greater increase in LS7 score in the intervention vs. control group across all CV risk factors, with significant differences among those with overweight/obesity (1.77, p&lt;.0001) and with 2+ or 3+ CV risk factors (1.00, p=.03; 1.09, p=.04). Compared to the control group, the increase in the percentage of participants with ideal LS7 scores in the intervention group was higher among those with overweight/obesity, HTN, diabetes and 3+ CV risk factors. Conclusions: Our culturally tailored mHealth lifestyle intervention was associated with notable increases in LS7 scores among AAs with preexisting CV risk factors, suggesting its efficacy in improving CVH among this population.

Association of triglyceride-glucose index with incident hypertension among non-overweight healthy adults: A cohort study in China

Background and aimsOverweight and obesity are well recognized as important and traditional risk factors for hypertension (HTN), but the prevalence of HTN tends to increase in non-overweight people. Triglyceride-glucose (TyG) index has been observed to be associated with HTN. However, whether such association still persists in non-overweight people remains unclear. The aim of our cohort study was to explore the link between TyG index and incident HTN in non-overweight Chinese population. Methods and resultsAs many as 4678 individuals without HTN at baseline were involved, who underwent at least two years of health check-ups in the eight-year study period and maintained non-overweight at follow-up. According to baseline TyG index quintiles, participants were classified into five groups. Compared with the 1st quantile, those in the 5th quantile of TyG index had a 1.73-fold (HR 95% CI 1.13–2.65) risk of incident HTN. The results remained consistent when analyses were restricted to participants without abnormal TG or FPG level at baseline (HR 1.62, 95% CI 1.17–2.26). Furthermore, the subgroup analyses were conducted, the risk of incident HTN was still significantly increased with increasing TyG index for subgroups of older participants (age≥ 40 years), males, females and higher BMI group (BMI≥ 21 kg/m2). ConclusionsThe risk of incident HTN increased with increasing TyG index among Chinese non-overweight adults, so TyG index might be a reliable predictor of incident HTN among adults maintaining non-overweight.

Going for -ing or -en? A Puzzle about Adjectival Participles for Learners of English

Abstract This study investigates how learners of English process adjectival participles in both attributive and predicative positions within sentences in order to identify whether difficulties associated with participles stem from learner-specific or English-specific characteristics. A Chinese-speaking group and a mixed language group participated in Study 1 that used the target sentence in English as L2 without contextual cues. A subgroup of the Chinese participants took part in Study 2 that used target sentences with contextual cues. Results showed that the two groups’ performance was different in the use of pre-nominal attributive adjectival participles after controlling for English proficiency (Study 1). Contextual cues did not facilitate Chinese learners’ performance (Study 2). The target word frequency effects disappeared when contextual cues were provided. These findings suggest that the complexities of adjectival participles reside not only in the linguistic characteristics of English, but also in the learner characteristics of L1 background and English proficiency.

Access to nutrition services and information after active cancer treatment: a mixed methods study

PurposeEvidence-based guidelines for cancer strongly support nutrition and dietetic services for people with cancer and carers in order to improve patient-centred and health service outcomes. Access to nutrition services and information after completing active cancer treatment is relatively unknown in Australia. This study aimed to determine the availability, accessibility, barriers, and preferences to nutrition services and information after cancer treatment in Australia.MethodsUtilising mixed methods, people with cancer and carers completed a cross-sectional survey, and a sub-group of participants completed a semi-structured interview. The survey evaluated the availability of nutrition services, nutrition information searched, barriers, and preferences for nutrition information. Semi-structured interviews explored participant experience with nutrition services and information.ResultsThe 149 participants (including 10 carers) were predominately male and with a diagnosis of prostate cancer (63%). Overall, 23% of participants received nutrition information from a dietitian after cancer treatment. Participants (78%) indicated that accessing a nutrition specialist is the main barrier to receiving nutrition care after treatment. Most searched nutrition information on the internet (55%) and found the information easy to understand (89%), but conflicting (52%). Thematic analysis of interviews in fourteen cancer patients revealed three key themes pertaining to (1) preferred referral and timing of nutrition services, (2) lack of confidence in publicly available nutrition information, and (3) streamlining nutrition services for greater access.ConclusionAccess to a dietitian and evidence-based information after cancer treatment is limited for people with cancer and carers in Australia, despite the high interest and need for ongoing nutrition care.Implications for Cancer SurvivorsModels of care evaluating the provision of appropriate nutrition care and information provision after cancer treatment are needed to address this unmet survivorship need.

Naltrexone plus bupropion reduces cigarette smoking in individuals with methamphetamine use disorder: A secondary analysis from the CTN ADAPT-2 trial

IntroductionMethamphetamine (MA) use is marked by high rates of comorbid tobacco smoking, which is associated with more severe drug use and worse clinical outcomes compared to single use of either drug. Research has shown the combination of naltrexone plus oral bupropion (NTX-BUP) improves smoking cessation outcomes in non-MA-using populations. In the Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) study, NTX-BUP successfully reduced MA use. Our aim in this secondary data analysis was to examine changes in cigarette smoking among the subgroup of participants reporting comorbid tobacco use in the ADAPT-2 trial. MethodsThe multi-site ADAPT-2 study used a randomized, double blind, sequential parallel comparison design to evaluate treatment with extended-release injectable NTX (380 mg every 3 weeks) combined with once-daily oral extended-release BUP (450 mg/day) vs matching injectable and oral placebo in outpatients with moderate or severe MA use disorder. The study assessed smoking outcomes, based on self-reported timeline followback (TLFB) data, twice/week for 13 weeks. ResultsOf the 403 participants in the ADAPT-2 trial, 290 reported being current cigarette smokers (71.9 %). The study found significant differences (p's < 0.0001) for each smoking outcome indicating greater change in the proportion of nonsmoking days, number of cigarettes smoked per week, and consecutive nonsmoking days, all favoring the group receiving NTX-BUP versus placebo. ConclusionsNTX-BUP was associated with significant reductions in self-reported cigarette smoking in the context of concurrent treatment for MA use disorder. These off-target medication effects warrant prospective investigation using biochemically confirmed measures of smoking abstinence. The development of NTX-BUP as a co-addiction treatment strategy has a potential for high public health impact.

An Exploratory Case-Control Study on the Associations of Bacterially-Derived Vitamin K Forms with the Intestinal Microbiome and Obesity-Related Osteoarthritis

BackgroundEvidence suggests that natural metabolites produced by intestinal microorganisms may have beneficial or harmful effects on osteoarthritis (OA). This could include menaquinones, which are bacterially-synthesized, biologically-active vitamin K forms abundant in the intestinal microbiome. ObjectivesThe overall goal of this study was to evaluate the association of intestinally-derived menaquinones with obesity-related OA. MethodsThis case-control study used data and biospecimens derived from a subgroup of Johnston County Osteoarthritis Study participants. Fecal menaquinone concentrations and microbial composition were determined in 52 obese participants with hand and knee OA and 42 age- and sex-matched obese participants without OA. The inter-relationships among fecal menaquinones were evaluated using principal component analysis. The differences in alpha and beta diversities and microbial composition across menaquinone clusters were evaluated using ANOVA. ResultsThe samples were clustered into the following 3 groups: cluster 1 characterized by higher fecal menaquinone-9 and -10 concentrations, cluster 2 characterized by lower overall menaquinone concentrations, and cluster 3 characterized by higher menaquinone-12 and -13 concentrations. Overall, fecal menaquinone clusters did not differ between participants with or without OA (P = 0.707). Microbial diversity did not differ across the fecal menaquinone clusters (all F-test P > 0.12). However, the relative abundance of bacterial taxa differed among clusters, with higher abundance of Coprococcus, Prevotella, and Eggerthella in cluster 2 than in cluster 1; higher abundance of Oscillospira, Dorea, Eubacterium, and Bacteroides in cluster 3 than in cluster 1; and higher abundance of Prevotella, Sutterella, and Dorea in cluster 3 than in cluster 2 (all P < 0.001). ConclusionMenaquinones were variable and abundant in the human gut, but the fecal menaquinone clusters did not differ with OA status. Although the relative abundance of specific bacterial taxa differed among fecal menaquinone clusters, the relevance of these differences with respect to vitamin K status and human health is uncertain.

Potentially inappropriate medication including drug-drug interaction and the risk of frequent falling, hospital admission, and death in older adults - results of a large cohort study (getABI).

Introduction: With growing age, multiple chronic diseases may result in polypharmacy. Drugs that should be avoided in older adults are called potentially inappropriate medications (PIM). Beyond PIM, drug-drug interactions (DDI) are known to be related to adverse drug events. This analysis examines the risk of frequent falling, hospital admission, and death in older adults associated with PIM and/or DDI (PIM/DDI) prescription. Materials and methods: This post hoc analysis used data of a subgroup of the getABI study participants, a large cohort of community-dwelling older adults. The subgroup comprised 2120 participants who provided a detailed medication report by telephone interview at the 5-year getABI follow-up. The risks of frequent falling, hospital admission, and death in the course of the following 2 years were analysed by logistic regression in uni- and multivariable models with adjustment for established risk factors. Results: Data of all 2,120 participants was available for the analysis of the endpoint death, of 1,799 participants for hospital admission, and of 1,349 participants for frequent falling. The multivariable models showed an association of PIM/DDI prescription with frequent falling (odds ratio (OR) 1.66, 95% confidence interval (CI) 1.06-2.60, p = 0.027) as well as with hospital admission (OR 1.29, 95% CI 1.04-1.58, p = 0.018), but not with death (OR 1.00, 95% CI 0.58-1.72, p = 0.999). Conclusion: PIM/DDI prescription was associated with the risk of hospital admission and frequent falling. No association was found with death by 2years. This result should alert physicians to provide a closer look at PIM/DDI prescriptions.

Sex differences in risk factors for end-stage kidney disease and death in type 2 diabetes: A retrospective cohort study.

This study investigated the sex differences in the risk of end-stage kidney disease (ESKD) and mortality, as well as the effect modification of sex on associated factors in patients with type 2 diabetes. This multicenter observational cohort study included 4328 patients with type 2 diabetes. Hazard ratios (HRs) with 95% confidence intervals (CIs) of sex for ESKD and death were estimated using Cox proportional regression with adjustment for baseline covariates. For assessing risk modification, HRs and incidence rates for ESKD and death were compared between sexes across patient characteristics using Cox proportional and Poisson regression models. During a median follow-up of 7 years, 276 patients (70% men) developed ESKD, and 241 patients (68% men) died. Men had higher risks of ESKD (HR 1.34; 95% CI 1.02-1.75; p=.034) and death (HR 1.64; 95% CI 1.24-2.16; p=.001) versus women after adjusting for multiple covariates. Among patients with microalbuminuria, men had a substantially higher risk of ESKD versus women, compared to those with normo- and macroalbuminuria (p for interaction .04). Incidence rates were also increased in men versus women with albuminuria of around 300 mg/g. No differences were detected in the association of sex and death across baseline patient subgroups. In type 2 diabetes, men had an increased risk of ESKD and death versus women. Moderately increased albuminuria was strongly associated with sex difference in developing ESKD.

A randomized trial of web-based fertility-tracking software and fecundability

To assess the effect of randomization to FertilityFriend.com, a mobile computing fertility-tracking app, on fecundability. Parallel non-blinded randomized controlled trial nested within the Pregnancy Study Online (PRESTO), a North American preconception cohort. Female participants aged 21 to 45 years attempting conception for ≤6 menstrual cycles at enrolment (2013-2019). Randomization (1:1) of 5532 participants to receive a premium Fertility Friend (FF) subscription. Fecundability (per-cycle probability of conception). Participants completed bimonthly follow-up questionnaires until pregnancy or a censoring event, whichever came first. We first performed an intent-to-treat analysis of the effect of FF randomization on fecundability. In secondary analyses, we used a per-protocol approach that accounted for adherence in each trial arm. In both analyses, we used proportional probabilities regression models to estimate fecundability ratios (FR) and 95% confidence intervals (CI) comparing those randomized vs. not randomized and applied inverse probability weights to account for loss-to-follow-up (intent-to-treat and per-protocol analyses) and adherence (per-protocol analyses only). Using life-table methods, 64% of the 2775 participants randomized to FF and 63% of the 2767 participants not randomized to FF conceived during 12 cycles; these respective percentages were each 70% among those with 0-1 cycles of attempt time at enrolment. Of those randomized to FF, 72% were defined as adherent (68% of observed menstrual cycles). In intent-to-treat analyses, there was no appreciable association overall (FR = 0.97; 95% CI, 0.90-1.04) or within strata of pregnancy attempt time at enrolment, age, education, or other characteristics. In per-protocol analyses, we observed little association overall (FR = 1.06; 95% CI, 0.99-1.14), but weak-to-moderate positive associations among participants who had longer attempt times at enrolment (FR = 1.15; 95% CI, 0.98-1.35 for 3-4 cycles; FR = 1.14; 95% CI, 0.87-1.48 for 5-6 cycles), were aged <25 years (FR = 1.29; 95% CI, 1.01-1.66), had ≤12 years of education (FR = 1.32; 95% CI, 0.92-1.89), or were non-users of hormonal contraception within 3 months before enrolment (FR = 1.10; 95% CI, 1.02-1.19). No appreciable associations were observed in intent-to-treat analyses. In secondary per-protocol analyses that accounted for adherence, randomization to FF was associated with slightly greater fecundability among selected subgroups of participants; however, these results are susceptible to unmeasured confounding.

Sensory salience processing moderates attenuated gazes on faces in autism spectrum disorder: a case–control study

BackgroundAttenuated social attention is a key marker of autism spectrum disorder (ASD). Recent neuroimaging findings also emphasize an altered processing of sensory salience in ASD. The locus coeruleus–norepinephrine system (LC-NE) has been established as a modulator of this sensory salience processing (SSP). We tested the hypothesis that altered LC-NE functioning contributes to different SSP and results in diverging social attention in ASD.MethodsWe analyzed the baseline eye-tracking data of the EU-AIMS Longitudinal European Autism Project (LEAP) for subgroups of autistic participants (n = 166, age = 6–30 years, IQ = 61–138, gender [female/male] = 41/125) or neurotypical development (TD; n = 166, age = 6–30 years, IQ = 63–138, gender [female/male] = 49/117) that were matched for demographic variables and data quality. Participants watched brief movie scenes (k = 85) depicting humans in social situations (human) or without humans (non-human). SSP was estimated by gazes on physical and motion salience and a corresponding pupillary response that indexes phasic activity of the LC-NE. Social attention is estimated by gazes on faces via manual areas of interest definition. SSP is compared between groups and related to social attention by linear mixed models that consider temporal dynamics within scenes. Models are controlled for comorbid psychopathology, gaze behavior, and luminance.ResultsWe found no group differences in gazes on salience, whereas pupillary responses were associated with altered gazes on physical and motion salience. In ASD compared to TD, we observed pupillary responses that were higher for non-human scenes and lower for human scenes. In ASD, we observed lower gazes on faces across the duration of the scenes. Crucially, this different social attention was influenced by gazes on physical salience and moderated by pupillary responses.LimitationsThe naturalistic study design precluded experimental manipulations and stimulus control, while effect sizes were small to moderate. Covariate effects of age and IQ indicate that the findings differ between age and developmental subgroups.ConclusionsPupillary responses as a proxy of LC-NE phasic activity during visual attention are suggested to modulate sensory salience processing and contribute to attenuated social attention in ASD.

Abstract WP173: Interaction Between CYP2C19 Allele Status And Outcome Following Ischemic Stroke In Patients Treated With Clopidogrel: A TARDIS Trial Substudy

Background: Clopidogrel is routinely prescribed following ischaemic stroke (IS), or transient ischaemic attack (TIA), as secondary prevention. Conversion of clopidogrel to its active form involves several hepatic cytochrome P450 enzymes (CYP450), including P450-2C19 (CYP2C19). Previous evidence suggests that CYP2C19 loss of function (LoF) carriers prescribed clopidogrel are at increased risk of vascular events in comparison with non-carriers. We sought to test for interaction between CYP2C19 LoF status and treatment effects in the TARDIS trial. Methods: TARDIS was an international, randomised trial recruiting participants with acute IS/TIA. Participants were assigned to receive intensive antiplatelet therapy (aspirin, clopidogrel, and dipyridamole) or guideline therapy (clopidogrel alone or aspirin and dipyridamole). Blood samples for genotyping were taken from consented participants at a 70 of the 106 recruiting centres. Results: Of 3096 participants, 1361 (44%) had samples available for genotyping. Median age was 69.0 years and 65.1% were male. Of the 1361 with samples, 1071 (78.7%) were randomised to clopidogrel and 290 (21.3%) to aspirin plus dipyridamole. 387 (28.4%) participants were CYP2C19 LoF allele carriers. At 35 days, 64 participants (4.7%) had a further IS/TIA and the rate of major adverse cardiovascular events was 6.8%. In participants randomised to clopidogrel (monotherapy or intensive) the rates of further IS/TIA were 4.9% in LoF allele carriers and 4.2% in non-carriers. As for those taking clopidogrel monotherapy, the rates of further IS/TIA were 7.4% in LoF allele carriers compared to 3.8% in non-carriers, though this difference was non-significant (p=0.14). There were no significant differences, in outcome or bleeding risk, by treatment group and LoF carrier status. Conclusions: No significant interaction was found between CYP2C19 genotype and outcome following IS/TIA when prescribed clopidogrel, either as monotherapy or in combination with aspirin and dipyridamole. There was no observed interaction between LoF status, clinical outcome, and bleeding rates. A caveat is that this analysis was undertaken on a subgroup of TARDIS participants and so was underpowered to detect a difference in the monotherapy group.

Two-year effect of semaglutide 2.4mg on control of eating in adults with overweight/obesity: STEP 5.

This study evaluatedthe effect of once-weekly semaglutide 2.4mg on 2-year control of eating. In STEP 5, adults with overweight/obesity were randomized 1:1 to semaglutide 2.4mg or placebo, plus lifestyle modification, for 104 weeks. A 19-item Control of Eating Questionnaire was administered at weeks 0, 20, 52, and 104 in a subgroup of participants. P values were not controlled for multiplicity. In participants completing the Control of Eating Questionnaire (semaglutide, n=88; placebo, n=86), mean body weight changes were -14.8% (semaglutide) and -2.4% (placebo). Scores significantly improved with semaglutide versus placebo for Craving Control and Craving for Savory domains at weeks 20, 52, and 104 (p < 0.01); for Positive Mood and Craving for Sweet domains at weeks 20 and 52 (p < 0.05); and for hunger and fullness at week 20 (p < 0.001). Improvements in craving domain scores were positively correlated with reductions in body weight from baseline to week 104 with semaglutide. At 104 weeks, scores for desire to eat salty and spicy food, cravings for dairy and starchy foods, difficulty in resisting cravings, and control of eating were significantly reduced with semaglutide versus placebo (all p < 0.05). In adults with overweight/obesity, semaglutide 2.4mg improved short- and longer-term control of eating associated with substantial weight loss.

Baclofen for alcohol use disorder.

Baclofen for alcohol use disorder.

Medical rehabilitation of patients with menopausal syndrome and surgical menopause: contribution of magnesium deficiency correction

Background. The increase in the proportion of patients with menopausal syndrome (MS) and surgical menopause, including women in the recovery phase after radical surgical treatment of the reproductive system cancer, is a characteristic trend of the 21st century. Part of them receive menopausal hormone therapy (MHT). This determines the relevance of the analysis of the specified cohort of patients to enhance rehabilitation programs designed to improve the quality of life (QoL) in this category of gynecological patients.Objective: subanalysis of primary data from the MAGYN study cohort of MHT treated women with MS and surgical menopause.Material and methods. The MAGYN observational non-interventional study of the real clinical practice included 9168 women, of whom 1528 represented a group of previously not characterized MHT treated women with MS and surgical menopause. To determine the number of patients with magnesium deficiency (MD), a Magnesium Deficiency Questionnaire (MDQ) was used, a biochemical blood test with an indicator of serum magnesium concentration was evaluated. The profile of the participants was analyzed by the presence of general somatic pathologies, obstetric, gynecological history, complaints, symptoms of MD on a visual-analog scale. The QoL was assessed with the help of The World Health Organization Quality of Life Brief Version (WHOQOL-BREF) before the start of a 4-week course of MD supplementation and after treatment.Results. According to the MDQ results, the prevalence of DM was 79.4%, which exceeded the results of all other groups in the study. Women with MD had a higher incidence of viral infections (19.2% vs. 22.7%; p=0.028), vegetative-vascular dystonia (26.2% vs. 29.7%; p=0.0466) and osteochondrosis (42.9% vs. 46.8%; p=0.0453). A subgroup of participants with verified MD demonstrated significantly more pronounced symptoms, such as irritability (4.9±3.5 vs. 4.6±3.4 points in the general group; p=0.0437), sleep disorders (4.4±2.3 vs. 4.2±2.3 points; p=0.0491), back pain (3.9±2.0 vs. 3.7±2.0; p=0.0405), and increased fatigue (4.6±2.3 vs. 4.4±2.3 points; p=0.0444). After the end of the course of therapy with fixed dose combination of magnesium citrate and pyridoxine, the sum of MDQ scores decreased from 46.0±12.7 to 29.2±15.1 points (p&lt;0.001) in combination with an increase in the plasma concentration of magnesium to 0.79±0.23 mmol/l; women's satisfaction with their physical, psychological, social well-being increased (from 21.1±4.5 to 26.2±3.5 points; from 24.8±4.9 to 28.1±4.4 points, and from 9.3±2.7 to 11.0±2.8 points, respectively; p&lt;0.001); self-perception increased from 18.2±3.7 to 22.2±3.6 points. Thus, there was a significant decrease in the severity of MD and a significant improvement in QoL according to WHOQOL-BREF, which is important in the rehabilitation of such patients.Conclusion. The profile of patients with MS and surgical menopause receiving MHT, including the period of recovery after radical surgical treatment of reproductive cancer, is characterized by MD and decreased QoL. It seems effective to introduce MD correction into the complex rehabilitation program of such patients. It is necessary to conduct further studies to improve the rehabilitation measures in this cohort of patients.

Neurofilament light level correlates with brain atrophy, and cognitive and motor performance.

The usefulness of neurofilament light (NfL) as a biomarker for small vessel disease has not been established. We examined the relationship between NfL, neuroimaging changes, and clinical findings in subjects with varying degrees of white matter hyperintensity (WMH). A subgroup of participants (n = 35) in the Helsinki Small Vessel Disease Study underwent an analysis of NfL in cerebrospinal fluid (CSF) as well as brain magnetic resonance imaging (MRI) and neuropsychological and motor performance assessments. WMH and structural brain volumes were obtained with automatic segmentation. CSF NfL did not correlate significantly with total WMH volume (r = 0.278, p = 0.105). However, strong correlations were observed between CSF NfL and volumes of cerebral grey matter (r = -0.569, p < 0.001), cerebral cortex (r = -0.563, p < 0.001), and hippocampi (r = -0.492, p = 0.003). CSF NfL also correlated with composite measures of global cognition (r = -0.403, p = 0.016), executive functions (r = -0.402, p = 0.017), memory (r = -0.463, p = 0.005), and processing speed (r = -0.386, p = 0.022). Regarding motor performance, CSF NfL was correlated with Timed Up and Go (TUG) test (r = 0.531, p = 0.001), and gait speed (r = -0.450, p = 0.007), but not with single-leg stance. After adjusting for age, associations with volumes in MRI, functional mobility (TUG), and gait speed remained significant, whereas associations with cognitive performance attenuated below the significance level despite medium to large effect sizes. NfL was strongly related to global gray matter and hippocampal atrophy, but not to WMH severity. NfL was also associated with motor performance. Our results suggest that NfL is independently associated with brain atrophy and functional mobility, but is not a reliable marker for cerebral small vessel disease.

Homelessness and Treatment Outcomes Among Black Adults With Opioid Use Disorder: A Secondary Analysis of X:BOT.

We sought to identify the sociodemographic and clinical characteristics associated with homelessnesss, and explore the relationship between homelessnesss and treatment outcomes among Black individuals. This is a secondary analysis of the subgroup of Black participants (n = 73) enrolled in "X:BOT," a 24-week multisite randomized clinical trial comparing the effectiveness of extended-release naltrexone versus sublingual buprenorphine-naloxone (n = 570). Outcomes included medication initiation, return to extramedical use of opioids assessed by both self-report and urine toxicology, and engagement in medications for opioid use disorder (MOUD) treatment at 28 weeks postrandomization. Descriptive statistics were performed. Black participants were mostly unmarried and male, and about a third were aged 21-30 years. Among people experiencing homelessnesss, more were uninsured (45.5% [10/22] vs 19.6% [10/51]), unemployed (77.3% [17/22] vs 64.7% [33/51]), and reported alcohol (40.9% [9/22] vs 23.5% [12/51]) and sedative use (54.5% [12/22] vs 17.6% [9/51]) within the previous 30 days. Compared with housed Black individuals, a slightly higher proportion of Black individuals experiencing homelessnesss successfully initiated study medication (81.1% [18/22] vs 72.6% [37/51]); similar proportions returned to opioid use during the trial (68.2% [15/22] vs 68.6% [35/51]) and were engaged in MOUD at 28 weeks after trial entry (72.2% [13/18] vs 69.7% [23/33]) among participants located for follow-up. These descriptive results among Black patients participating in a trial of MOUD suggest that efficacious MOUD is possible despite homelessnesss with additional clinical supports such as those provided by a clinical trial.