Tag: pubmed

JAMA Oncol. 2023 Jul 13. doi: 10.1001/jamaoncol.2023.2150. Online ahead of print.

ABSTRACT

IMPORTANCE: In spite of the effectiveness of endocrine therapy plus cyclin-dependent kinase (CDK) 4/6 inhibitors as the first-line treatment for estrogen receptor (ER)-positive, erb-b2 receptor tyrosine kinase 2 (ERBB2 [formerly HER2/neu])-negative (ER+/ERBB2-) metastatic breast cancer (MBC), patients eventually develop resistance, and eventually most will receive chemotherapy. The METEORA-II trial compared a metronomic all-oral treatment with intravenous (IV) chemotherapy.

OBJECTIVE: To compare the efficacy of the oral vinorelbine plus cyclophosphamide plus capecitabine (VEX) regimen vs weekly IV paclitaxel among patients with ER+/ERBB2- MBC who are candidates for chemotherapy.

DESIGN, SETTING, AND PARTICIPANTS: This phase 2 randomized clinical trial including 140 women 18 years and older (randomized 1:1) with ER+/ERBB2- MBC was carried out from September 13, 2017, to January 14, 2021 at 15 centers in Italy. Eligible patients could have received 1 prior line of chemotherapy for MBC and/or 2 lines of endocrine therapy (including CDK4/6 inhibitors).

INTERVENTIONS: In 4-week cycles, patients received either metronomic oral VEX or weekly IV paclitaxel.

MAIN OUTCOMES AND MEASURES: The primary end point was investigator-assessed time to treatment failure (TTF) defined as the interval between the date of randomization to the end of treatment (because of disease progression or lack of tolerability or because further trial treatment was declined). Secondary end points included progression-free survival (PFS), overall survival (OS), and disease control rate (complete or partial response or stable disease lasting for at least 24 weeks).

RESULTS: In total, 133 patients received either VEX (n = 70) or paclitaxel (n = 63) in 4-weekly cycles. The median age was 61 (range, 30-80) years. The VEX treatment significantly prolonged TTF vs paclitaxel (hazard ratio [HR], 0.61; 95% CI, 0.42-0.88; P = .008), median TTF was 8.3 (95% CI, 5.6-11.1) months for VEX vs 5.7 (95% CI, 4.1-6.1) months for paclitaxel, and the 12-month TTF was 34.3% for VEX vs 8.6% for paclitaxel. The median PFS was 11.1 (95% CI, 8.3-13.8) months vs 6.9 (95% CI, 5.4-10.1) months favoring VEX (HR, 0.67; 95% CI, 0.46-0.96, P = .03). The 12-month PFS was 43.5% for VEX vs 21.9% for paclitaxel. No difference in OS was found. The TF event for 55.6% of patients was progression of disease; for 23% it was AEs. More patients assigned to VEX had at least 1 grade 3 or 4 targeted adverse event (VEX, 42.9%; 95% CI, 31.1%-55.3% vs paclitaxel, 28.6%; 95% CI, 17.9%-41.3%), but essentially no alopecia.

CONCLUSION AND RELEVANCE: This randomized clinical trial found significantly prolonged TTF and PFS for oral VEX but no improvement in OS compared with intravenous paclitaxel, despite increased but still manageable toxic effects. The VEX regimen may provide more prolonged disease control than weekly paclitaxel for ER+/ERBB2- MBC.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02954055.

PMID:37440239 | DOI:10.1001/jamaoncol.2023.2150

JAMA Netw Open. 2023 Jul 3;6(7):e2323205. doi: 10.1001/jamanetworkopen.2023.23205.

ABSTRACT

IMPORTANCE: Common mental disorders (CMD), which include depression and anxiety, are prevalent among people living with HIV and are associated with suboptimal antiretroviral therapy (ART) adherence.

OBJECTIVE: To assess the effect of a lay health worker-led psychological intervention on ART adherence, virologic suppression, and mental health symptoms.

DESIGN, SETTING, AND PARTICIPANTS: Open-label pragmatic cluster trial with 1:1 block randomization of 16 health facilities in rural Bikita, Zimbabwe. Recruitment occurred from October 2018 to December 2019, and participants were followed up for 12 months, ending in December 2020. Participants were adults aged 18 years and older, who spoke English or Shona, screened positive for CMD (Shona Symptoms Questionnaire [SSQ]-14 score ≥9), received first-line ART for 6 or more months, had no World Health Organization stage 4 disease, no psychosis, were not pregnant, and provided informed consent. Data were analyzed from March 2021 to February 2022.

INTERVENTION: The Friendship Bench, consisting of 6 lay health worker-led weekly problem-solving therapy sessions and optional peer-led group support.

MAIN OUTCOMES AND MEASURES: The primary outcome was mean adherence during 2 to 6 months of follow-up, and the secondary outcomes were mean adherence during 1 to 12 months of follow-up, change in SSQ-14 and Patient Health Questionnaire (PHQ-9) scores (3, 6, 9, and 12 months), and viral load suppression (6 and 12 months).

RESULTS: A total of 516 participants were recruited (244 in Friendship Bench and 272 in enhanced standard care facilities); 438 (84.9%) were female and the mean (SD) age was 45.6 (10.9) years. Mean (SD) adherence between 2 to 6 months was 89.9% (18.4%) in the Friendship Bench group and 87.2% (20.1%) in the control group. The intervention had no statistically significant effect on adherence between 2 to 6 months (unadjusted mean difference, 1.93 percentage points; 95% CI, -1.20 to 5.06 percentage points; P = .23), between months 1 to 12 (mean difference 0.79 percentage points; 95% CI, -2.14 to 3.71 percentage points; P = .60), or viral suppression. Declines in SSQ-14 scores from baseline to 3 months (difference, -1.65; 95% CI, -3.07 to -0.24), 6 months (difference, -1.57; 95% CI, -2.98 to -0.15), and 9 months (difference, -1.63; 95% CI, -3.05 to -0.22) were greater in the Friendship Bench than the standard care group (P < .05). There were no differences in the decline in the SSQ-14 scores from baseline to 12 months and in declines in PHQ-9 scores from baseline to 3, 6, 9, and 12 months.

CONCLUSIONS AND RELEVANCE: In this randomized trial of HIV-positive participants with CMD, the Friendship Bench intervention had no effect on adherence and viral suppression, possibly due to the absence of skill-based adherence training and a ceiling effect.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03704805.

PMID:37440230 | DOI:10.1001/jamanetworkopen.2023.23205

J Music Ther. 2023 Jul 13:thad010. doi: 10.1093/jmt/thad010. Online ahead of print.

ABSTRACT

Change in music therapy is often modeled linearly. In linear analysis, change is represented as the difference between the scores recorded before and after treatment, where changes in the input are proportional to the output. However, changes in complex systems are often not linear and depend on time. We propose Dynamic Systems Theory (DST) as a means to overcome the shortcomings of linear analysis and enrich the study of change in music therapy. This article aims to introduce and critically discuss the applications of DST in music therapy, focusing on its theoretical and methodological aspects. DST offers a meta-framework to model nonlinear change in music therapy, considering time as continuous. The application of DST can further enhance the understanding of how music therapy works, the shape of the change, and how the relevant therapeutic processes within music therapy support therapeutic change. An introduction to DST theory is provided along with its history, implications, assessment methods, statistical analyses, mathematical modeling, and implementation examples in music therapy research.

PMID:37440201 | DOI:10.1093/jmt/thad010

Nucl Med Commun. 2023 Jul 14. doi: 10.1097/MNM.0000000000001735. Online ahead of print.

ABSTRACT

OBJECTIVE: Metastatic castration resistant-prostate cancer (mCRPC) is deadly condition that remains incurable despite various therapies. Initial studies have shown promising results with Lutetium-177 prostate-specific membrane antigen (177Lu-PSMA) therapy for advanced prostate cancer. However, most of the published efficacy and safety data is retrospective. The purpose of the study was to prospectively evaluate the therapeutic efficacy and safety results of 177Lu-PSMA therapy in mCRPC patients after 2 cycles.

METHODS: Twenty-five patients of mCRPC, treated with standard care treatment were enrolled for 2 cycles of 177Lu-PSMA therapy. Prostate-specific antigen (PSA), Eastern Cooperative Oncology Group (ECOG) performance status, Visual Analogue Score (VAS) and Analgesic Quantification Scale (AQS) for efficacy and hemoglobin, total leukocyte, platelets and serum creatinine for toxicity were recorded pre and post-therapy. Paired sample t-test was used for statistical analysis.

RESULTS: Treated patients with mean PSA level of 157 ng/ml received mean dose of 6.84 GBq of 177Lu-PSMA. For PSA, partial response (PR) was seen in 11/25 (44%), stable disease (SD) in 8/25 (32%) and progressive disease (PD) in 6/25 (24%) patients. Grade 1 and 2 hemoglobin toxicity was seen in 5/25 (20%) and 6/25 (24%) patients respectively. No patient developed grade 3 or 4 bone marrow toxicities. Grade 1 and 2 nephrotoxicity was seen in 1 patient each. Statistically significant difference was seen in ECOG, VAS and AQS scores (P < 0.001). No significant nephrotoxicity was observed (P = 0.558).

CONCLUSION: Efficacy and safety of 177Lu-PSMA therapy after 2 cycles have shown significant PSA response and pain palliation in heavily pretreated mCRPC patients.

PMID:37440195 | DOI:10.1097/MNM.0000000000001735

J Hand Surg Eur Vol. 2023 Jul 13:17531934231187553. doi: 10.1177/17531934231187553. Online ahead of print.

ABSTRACT

We developed a classification for open hand fractures based on risk score to predict the risk of infection requiring re-debridement. A total of 846 retrospectively included patients underwent multivariable analysis with backward elimination to derive the predictive risk score from independent predictors. The incidence of infection requiring re-debridement was 4%. Independent predictors include diabetes mellitus or immunocompromised condition, injuries from a bite, fractures with comminution/bone loss, neurovascular injuries and inadequate soft tissue coverage. The area under the receiver operating characteristic curve of the prediction score was 0.79. The new classification system for open hand fractures divides patients into three groups: low-risk open fractures (Type I, score <1); moderate-risk open fractures (Type II, score 1 to 2.5); and high-risk open fractures (Type III, score >2.5), based on the risk of infection requiring re-debridement. Re-debridement and delayed primary closure are suggested for type III open fractures.Level of evidence: III.

PMID:37440189 | DOI:10.1177/17531934231187553

Egypt J Immunol. 2023 Jul;30(3):74-81.

ABSTRACT

Chronic lymphocytic leukemia (CLL) is a malignant blood disorder in which there is an excess of white blood cells (lymphocytes) in blood and lymphoid tissues. CLL patients experience different clinical behaviors with diversity in disease course and outcome. Accordingly, prognostic markers are crucial for employing appropriate therapy protocols. CD163 (cluster of differentiation 163) is a monocyte/macrophage receptor. Soluble CD163 (sCD163) is an emerging prognostic player in the field of hematopoietic neoplasms. This study aimed to assess the prognostic potential of sCD163 as a serological marker in CLL. The study included 41 CLL patients and 44 apparently normal healthy volunteers as controls. Expression of CD38 and cytoplasmic ZAP 70 in CLL cells was assessed using flow cytometry. Beta 2 microglobulin (B2M), sCD23, and sCD163 serological markers were measured by ELISA. Serum levels of sCD163 were statistically significantly higher in CLL cases compared to controls (p=0.000). sCD163 levels were positively correlated with absolute lymphocyte count, sCD23, and B2M levels (p= 0.027, p=0.01, and p=0.004, respectively). In conclusion, levels of sCD163 in CLL is a promising prognostic tool for evaluating disease progression.

PMID:37440184

Cannabis Cannabinoid Res. 2023 Jul 13. doi: 10.1089/can.2022.0338. Online ahead of print.

ABSTRACT

Background: The use of cannabis with various forms of exercise (e.g., running) has received increased media attention in recent years, contradicting the popular stereotype that cannabis is associated with sedentary behavior. Although cross-sectional evidence suggests a positive association between cannabis use and exercise engagement, to date, the acute effects of cannabis on exercise remain unclear. Methods: The present within-subjects crossover study compared participants’ experiences of running after ad libitum use of legal market cannabis (cannabis run) to running without cannabis (non-cannabis run) in a real-world setting. Participants (n=49) were cannabis users between the ages of 21 and 49 years (mean=30.82, standard deviation [SD]=6.21). The majority of participants were male (61.5%) and non-Hispanic White (81.6%). Results: Participants (n=49) ran an average of 3.88 miles (SD=2.28) during their cannabis and non-cannabis runs. Although participants ran an average of 31 seconds/mile slower during their cannabis run, this difference was not statistically significant (p=0.12). Participants reported experiencing (1) less negative affect (p=0.03), (2) greater feelings of positive affect (p<0.001), tranquility (p=0.004), enjoyment (p=0.004), and dissociation (p=0.001), and (3) more runner’s high symptoms (p<0.001) during their cannabis (vs. non-cannabis) runs. Participants also reported lower pain levels after their cannabis (vs. non-cannabis) run (p=0.03). Perceived exertion did not differ between runs (p=0.33). Cannabis form, cannabinoid content, and feelings of “high” were largely unrelated to participants’ experience of exercise while under the influence of cannabis. Conclusions: Results suggest that acute cannabis use may be associated with a more positive exercise experience among regular cannabis users. Research using varied methodologies, a range of exercise modalities, and diverse populations is needed to establish the long-term harms and benefits associated with this behavior, as well as the generalizability of these findings to other populations and settings.

PMID:37440169 | DOI:10.1089/can.2022.0338

Braz J Microbiol. 2023 Jul 13. doi: 10.1007/s42770-023-01056-5. Online ahead of print.

ABSTRACT

Denim, also known as jeans, is a fabric made up of braided cotton threads dyed indigo blue, whose fibers contain approximately 10% of non-cellulosic impurities that reduce its commercial value. Microbial enzymes can act in the cleaning and desizing processes of jeans, improving their color, softness, and covering capacity. The recombinant Xylanase II (XynA2) from the aquatic bacterial Caulobacter crescentus (C. crescentus), previously characterized in terms of its biochemical features, was applied to the biotreatment of jeans to clean and degum it. The biotreatment performance was evaluated in terms of tissue weight loss, amount of reducing sugars released and analysis of the images obtained by scanning electron microscopy (SEM). Biotreated tissues, at 12 and 24 h, showed a dry weight loss of 4.9 and 6.6%, respectively. The reducing sugars amount released after XynA2 action over the jean’s fibers showed statistically significant values when compared with each other and with their respective controls. SEM images clearly shown that the fabric treated for 12 h presented a smooth and polished surface, while the fabric treated for 24 h showed the cotton fibers broken, displaying severe damage to the textile. The best treatment for the jeans was in the presence of 1 U mg^-1 XynA2 at pH 8 and 60 °C during 12 h. In conclusion, XynA2 of C. crescentus was satisfactorily applied for the biopolishing of denim jeans being a more sustainable alternative to the use of chemical and abrasive processes to obtain the same effects.

PMID:37440124 | DOI:10.1007/s42770-023-01056-5

Endocrine. 2023 Jul 13. doi: 10.1007/s12020-023-03448-x. Online ahead of print.

ABSTRACT

INTRODUCTION: Functional Hypothalamic Amenorrhea (FHA) has been associated with excessive-chronic stress, eating disorders, and weight loss. A common feature is the increased serum cortisol, but its measurement has many limitations. Currently, salivary cortisol (SC) has been proposed as a more sensitive and adequate index.

AIM: To investigate the SC alterations through a 24-h period and the possible correlation with the severity of stress in women with FHA.

METHODS: Between July 2019 and March 2021, 12 FHA women and 12 healthy controls of comparable age were included. Psychological, eating, and physical abnormalities were evaluated by applying equivalent validated self-questionnaires.

RESULTS: No significant differences were found between FHA women and healthy individuals with respect to morning (8:00 am) serum cortisol and ACTH (522.5 ± 162.2 vs 442 ± 138.5 nmol/l; p = 0.204 and 37 ± 44.8 vs 17.4 ± 10.8 pg/ml; p = 0.186, respectively). Women with FHA had statistically significant higher morning SC compared to control subjects (21.8 ± 5.9 nmol/l vs 12.8 ± 3.8 nmol/l; p < 0.001), while no significant differences were found regarding the afternoon (4:00 pm) and midnight (12:00 am) SC. A significant positive correlation was found between morning SC and morning serum cortisol (rho = 0.532; p = 0.007), EAT-26 (rho = 0.527; p = 0.008) and HADS-Anxiety score (rho = 0.471; p = 0.02). Additionally, a significant negative correlation between morning SC and BMI was observed (rho = -0.53; p = 0.009).

CONCLUSION: Compared to serum cortisol, SC seems to express better the hypercortisolemic state of women with FHA and correlates well with the underlying contributing factors. Larger studies are needed in order to confirm these results and validate the optimal SC cut-off value associated with the development of FHA.

PMID:37440104 | DOI:10.1007/s12020-023-03448-x

J Neurooncol. 2023 Jul 13. doi: 10.1007/s11060-023-04389-1. Online ahead of print.

ABSTRACT

PURPOSE: To test the effects of the Relaxation Response Resiliency Program – Neurofibromatosis (3RP-NF), a mind-body resilience program for people with NF, on resilience factors from baseline to post-treatment and 6- and 12-month follow-up.

METHODS: This is a secondary analysis of a fully powered randomized clinical trial (RCT) of 3RP-NF and health education control (HEP-NF). We recruited adults with NF1, NF2, or schwannomatosis who reported stress or difficulty coping with NF symptoms. Both conditions received 8 weekly 90-minute group sessions; 3RP-NF focused on building resilience skills. We measured resilience factors via the Measure of Current Status-A (adaptive coping), Cognitive and Affective Mindfulness Scale-Revised (mindfulness), Gratitude Questionnaire-6 (gratitude), Life Orientation Test Optimism Scale (optimism), and Medical Outcomes Study Social Support Survey (perceived social support) at baseline, post-intervention, and 6- and 12-month follow-up. We used linear mixed models with completely unstructured covariance across up to four repeated measurements (baseline, post-treatment, and 6- and 12-month follow-up) to investigate treatment effects on resilience factors.

RESULTS: We enrolled 228 individuals (M_age=42.7, SD = 14.6; 74.5% female; 87.7% White; 72.8% NF1, 14.0% NF2, 13.2% schwannomatosis). Within groups, both 3RP-NF and HEP-NF showed statistically significant improvements in all outcomes across timepoints. 3RP-NF showed significantly greater improvement in adaptive coping compared to HEP-NF from baseline to post-intervention and baseline to 6 months (M_difference= 0.29; 95% CI 0.13-0.46; p < 0.001; M_difference= 0.25; 95% CI 0.07-0.33; p = 0.005); there were no other between-group differences amongst the remaining resilience factors.

CONCLUSION: 3RP-NF showed promise in sustainably improving coping abilities amongst people with NF.

TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT03406208. Registration submitted December 6, 2017, first patient enrolled October 2017.

PMID:37440099 | DOI:10.1007/s11060-023-04389-1