UNASSIGNED: Few Spanish mindfulness interventions have been evaluated in Latinx patients with cancer. We culturally adapted a mindfulness intervention for Spanish speaking Latinx patients. The objective was to measure feasibility and acceptability as primary outcomes, with changes in anxiety, depression, and sleep as secondary outcomes.
UNASSIGNED: Spanish-speaking Latinx patients with breast cancer (n = 31) were randomized, between April 2021 and May 2022 to either intervention or wait-list control groups. The mindfulness intervention consisted of 6-weekly 1.5-hour sessions remotely delivered by a novice facilitator. Cultural adaptations included language, metaphor, goal, concept, trauma informed, and acknowledgement of spirituality. Feasibility was benchmarked as 75% of participants attending their first session, 75% of participants completing 4 of 6 sessions, and scoring ≥ 4 on a 5-point Likert feasability scale measuring ability to implement changes after 6-weeks. Acceptability was measured as scoring ≥ 4 on a 5-point Likert scale measuring usefulness and relevance of the mindfulness intervention for each session. An intention-to-treat, linear mixed model with repeated measures analysis examined changes in anxiety, depression, and sleep at week 6 and 18 (3 months post intervention).
UNASSIGNED: All three feasibility benchmarks were met with 75% of first session attendance, 96% of participants completing 4 of 6 sessions, and 94% scoring ≥ 4, on the feasibility scale (Mean (SD) = 4.3 (0.6)). Acceptability scores for both usefulness and relevance questions were ≥ 4 across all 6 sessions. Anxiety was significantly reduced at 3 months (-3.6 (CI -6.9, -0.2), P = .04), but is of unclear clinical significance given the small change. Depression scores declined, but not significantly, and there were no changes in sleep.
UNASSIGNED: This culturally adapted, remotely delivered mindfulness intervention using a novice facilitator was acceptable and feasible and demonstrated associated reductions in anxiety amongst Spanish speaking Latinx patients with breast cancer.
UNASSIGNED: ClinicalTrials.gov ID# NCT04834154.

OBJECTIVE: This study aimed at evaluating the effects of online and offline hybrid weight management approach based on the Fogg behavior model on total gestational weight gain and perinatal outcomes.
METHODS: Pregnant women in Hainan, the southernmost province of China, were recruited into a randomized controlled trial, which was designed to develop a WeChat platform for pregnancy weight management, and implement individualized and continuous pregnancy weight management services for pregnant women under the guidance of the Fogg behavior model. All pregnant women participating in the study were included in the full analysis set (FAS) for analysis. The pregnant women who completed the intervention and provided all outcome indicators were included in the per protocol set (PPS) for outcome evaluation.
RESULTS: Fifty-eight pregnant women were included in FAS analysis, and 52 pregnant women were finally included in PPS analysis. There was no statistically significant difference (P > 0.05) between the two groups at baseline. The gestational weight gain of the intervention group was significantly lower than that of the control group (P < 0.05). In the control group, the rate of appropriate weight gain during pregnancy was 48.26%, the rate of appropriate weight gain during pregnancy was 93.30% in the intervention group, with a statistically significant difference (P < 0.05). In the delivery outcomes, the cesarean section rate in the intervention group was significantly lower than that in the control group, and the differences were statistically significant (P < 0.05). The incidence of gestational diabetes mellitus and gestational hypertension in the intervention group was lower than those in the control group, and the differences were statistically significant (P < 0.05). The neonatal weight and incidence of macrosomia of the intervention group were lower than that of the control group, and the difference was statistically significant (P < 0.05).
CONCLUSIONS: This study combined the individualized and continuous pregnancy weight management of the online WeChat platform and offline consultation based on the Fogg behavior model, showing great potential in improving maternal and infant outcomes.
BACKGROUND: The study was registered with www.chictr.org.cn/index.aspx , Chinese Clinical Trial Registry (ChiCTR2200066707, 2022-12-14, retrospectively registered).

BACKGROUND: Lithiasis is a common and recurrent disease. Flexible ureteroscopy (fURS) is the cornerstone of laser treatment of kidney stones. Kidney stones destruction requires its laser pulverization into small fragments in order to remove them through the ureter or improve their spontaneous expulsion along the urinary tract. However, most of the time, all the micro-fragments and dust created cannot be extracted using our surgical tools and may stay intra-renally at the end of the procedure. Adjuvant treatments (such as forced diuresis, inversion or mechanical pressure) were previously described to improve the expulsion of stone fragments after extra-corporeal shock wave lithotripsy. Nevertheless, the impact of adjuvant treatment after fURS remains unclear and mainly theoretical.
OBJECTIVE: The primary objective is to show that the injection of 40 mg of furosemide in slow intravenous during 10 min, after the procedure, increases the stone-free rate 3 months after a fURS for destruction of kidney stones with laser.
METHODS: The study will be a two-parallel group randomized, controlled, multicentric trial with a blinding evaluation. Nine French departments of urology will participate. Patients will be randomized in 2 groups: the experimental group (injection of 40 mg of furosemide at the end of the surgery) and a control one (usual care). Patients will be followed up for 3 months (± 2 weeks) after the surgery. Then, we will perform a low dose abdomino-pelvic CT scan. The primary outcome is the stone-free rate at 3 months. A centralized review of the images will be performed by two specialized radiologists, in a blind and crossed way to allow a homogenization of the results. The secondary outcomes will include the rate of early post-operative urinary tract infection (UTI), the evaluation of post-operative pain, and the safety of the use of furosemide in patients treated by fURS for renal stone laser destruction. As secondary objectives, it is also planned to look at the effect of the prescription of an alpha-blocker as usual treatment on stone-free rate and to assess the agreement between the imaging analysis of the urologist and the specialized radiologist.
CONCLUSIONS: Lithiasis is a public health problem. It affects about 10% of the general population. This prevalence is increasing (multiplied by 3 in 40 years), partly due to changes in the population\'s eating habits over the years. The lithiasis patient is a patient with a chronic disease requiring annual follow-up and who may suffer from multiple recurrences, with a recurrence rate at 5 years of 50%. Recurrences are partly due to residual fragments left in the kidneys at the end of the operation. Other risk factors for recurrence include dietary hygiene and the presence of an associated metabolic disease. The metabolic blood and urine tests recommended by the Association Française d\'Urologie (AFU) can be used to manage these last two problems. As far as residual fragments are concerned, their presence leads to an early recurrence of stones because they form the bed for a new aggregation of crystals in the kidneys. Being able to reduce the rate of residual fragments in patients with the use of furosemide at the end of the intervention therefore seems essential in the management of recurrences in our patients. This will also improve our patients\' quality of life. Indeed, lithiasis disease leads to chronic pain associated with acute pain that motivates consultations to the emergency for specialized management. This study is the first to evaluate the impact of forced diuresis with the use of furosemide on the stone-free rate after a fURS for destruction of kidney stone with laser.
BACKGROUND: ClinicalTrials.gov Identifier: NCT05916963 , first received: 22 June 2023. EU Clinical Trials Register EudraCT Number: 2022-502890-40-00.

Background: Diabetes is a rapidly growing global morbidity issue with high prevalence, and the associated dysglycemia leads to complications. Patients with type 2 diabetes mellitus (T2DM) often experience elevated anxiety levels, affecting their quality of life and diabetes management. This study investigated quercetin, a nutraceutical and potential senolytic with antioxidant activity, to detect its possible positive effect on the bio-clinical measurements and routine health of patients with T2DM. Methods: This prospective randomized controlled trial (RCT) investigated the clinical usefulness of quercetin in patients with T2DM receiving non-insulin medications. One hundred participants were stratified by age and sex (1:1) and randomized to control (n = 50) or intervention (n = 50) groups. The control received standard care only, while the intervention received 500 mg quercetin daily for 12 weeks, followed by an 8-week washout and a final consecutive 12-week supplementation period (total: 32 weeks), as adjunct to their usual care. Comprehensive health assessments, including blood analyses, were conducted at baseline and study termination. Quality of life and anxiety were assessed using the 36-item Short Form Health Survey (SF-36) and Short Anxiety Screening Test (SAST-10). Results: Eighty-eight patients with T2DM concluded the trial. Compared with the control, glycated hemoglobin (HbA1c) levels showed a significant decrease (Δ%-change: -4.0% vs. 0.1%, p = 0.011). Quercetin also significantly improved PiKo-6 readings (FEV1: 5.6% vs. -1.5%, p = 0.002), systolic blood pressure (-5.0% vs. -0.2%, p = 0.029), night-time sleep (11.6% vs. -7.3%, p < 0.001), anxiety levels (SAST-10) (-26.2% vs. 3.3%, p < 0.001), and quality of life (SF-36) (both physical and mental components, p < 0.001). Conclusions: Based on the current open-label study, quercetin appears to be a promising supplement for T2DM, providing lifestyle and care support. Further research is warranted to shift this potential from clinical usefulness and feasibility to multidisciplinary evidence.

UNASSIGNED: Severe and critical COVID-19 disease is characterized by hyperinflammation involving pro-inflammatory cytokines, particularly IL-6. Tocilizumab is a monoclonal antibody that blocks IL-6 receptors.
UNASSIGNED: This study evaluated the efficacy of tocilizumab in Filipino patients with severe to critical COVID-19 disease.
UNASSIGNED: This phase 3 randomized double-blind trial, included patients hospitalized for severe or critical COVID-19 in a 1:1 ratio to receive either tocilizumab plus local standard of care or placebo plus standard of care. Patients were eligible for a repeat IV infusion within 24-48 hours if they deteriorated or did not improve. Treatment success or clinical improvement was defined as at least two categories of improvement from baseline in the WHO 7-point Ordinal Scale of patient status, in an intention-to-treat manner.
UNASSIGNED: Forty-nine (49) patients were randomized in the tocilizumab arm and 49 in the placebo arm. There was no significant difference in age, comorbidities, COVID-19 severity, need for mechanical ventilation, presence of acute respiratory distress syndrome, or biomarker levels between groups. Use of adjunctive therapy was similar between groups, with corticosteroid used in 91.8% in tocilizumab group and 81.6% in the placebo group, while remdesivir was used in 98% of participants in both groups.There was no significant difference between groups in terms of treatment success in both the intention-to-treat analysis (relative risk=1.05, 95% CI: 0.85-1.30) and per-protocol analysis (relative risk=0.98, 95% CI: 0.80 to 1.21). There was no significant difference in time to improvement of at least two categories relative to baseline on the 7-point Ordinal Scale of clinical status.
UNASSIGNED: The use of tocilizumab on top of standard of care in the management of patients with severe to critical COVID-19 did not result in significant improvement as defined by the WHO 7-point Ordinal Scale of patient status, nor in significant improvement in incidence of mechanical ventilation, incidence of ICU admission, length of ICU stay, and mortality rate.

UNASSIGNED: Uncontrolled hypertension is a common problem worldwide, despite the availability of many effective antihypertensive drugs and lifestyle interventions. We assessed the efficacy of a multi-component intervention in individuals with uncontrolled hypertension in a primary care setting.
UNASSIGNED: This study was a randomized, multicenter, parallel, two-arm, single-blind controlled trial performed in primary healthcare centers in Mallorca (Spain). All participants were 35 to 75-years-old and had poorly controlled hypertension. Patients were randomly assigned in a 1:1 ratio to a control group (usual care) or an intervention group (self-monitoring of blood pressure, self-titration of hypertensive medications, dietary interventions, and physical activity interventions). The primary outcome was decrease in the mean SBP at 6 months relative to baseline.
UNASSIGNED: A total of 153 participants were randomized to an intervention group (77) or a control group (76). After 6 months, the intervention group had a significantly lower systolic blood pressure (135.1 mmHg [±14.8] vs. 142.7 mmHg [±15.0], adjusted mean difference: 8.7 mmHg [95% CI: 3.4, 13.9], p < 0.001) and a significantly lower diastolic blood pressure (83.5 mmHg [±8.8] vs. 87.00 mmHg [±9.0], adjusted mean difference: 5.4 [95% CI: 2.9, 7.8], p < 0.0001). The intervention group also had significantly more patients who achieved successful blood pressure control (<140/90 mmHg; 54.4% vs. 32.9%, p = 0.011).
UNASSIGNED: Self-monitoring of blood pressure in combination with self-management of hypertensive medications, diet, and physical activity in a primary care setting leads to significantly lower blood pressure in patients with poorly controlled hypertension.Clinical Trial Registration: ClinicalTrials.gov, identifier ISRCTN14433778.

UNASSIGNED: Agile coaching, recognized as a more advanced methodology compared to education, is hypothesized to yield superior outcomes in enhancing psychological safety perception.
UNASSIGNED: Investigating the effectiveness of agile interventions versus no intervention on psychological safety perception, this randomized controlled trial aimed to clarify outcomes.
UNASSIGNED: The survey sample consisted of 54 licensed pharmacists, with each group comprising 18 participants: E1 underwent Agile Coaching, E2 underwent Agile Education, and C served as the control. After six weeks, psychological safety perception was measured using a validated scale, and statistical analyses, including the Kruskal-Wallis test and Mann-Whitney U test, were conducted.
UNASSIGNED: The group undergoing agile coaching showed the most substantial enhancements in psychological safety perception compared to others. Mann-Whitney U test revealed no significant difference in psychological safety perception between E1 and E2 groups before (Z = -0.938, p = 0.348) and after intervention (Z = -1.269, p = 0.204). Significant differences were observed between E1 and C both before (Z = -2.693, p = 0.007) and after intervention (Z = -1.414, p = 0.157). Significant differences were found between E2 and C before (p = 0.038) but not after intervention (p = 0.962).
UNASSIGNED: The findings suggest that agile coaching could be an effective intervention for enhancing psychological safety in organizational settings, particularly in community pharmacies. Further research is warranted to explore long-term effects and generalize findings to broader contexts.

BACKGROUND: There are no recent studies comparing the compliance rates of both patients and observers in tuberculosis treatment between the video-observed therapy (VOT) and directly observed therapy (DOT) programs.
OBJECTIVE: This study aims to compare the average number of days that patients with pulmonary tuberculosis and their observers were compliant under VOT and DOT. In addition, this study aims to compare the sputum conversion rate of patients under VOT with that of patients under DOT.
METHODS: Patient and observer compliance with tuberculosis treatment between the VOT and DOT programs were compared based on the average number of VOT and DOT compliance days and sputum conversion rates in a 60-day cluster randomized controlled trial with patients with pulmonary tuberculosis (VOT: n=63 and DOT: n=65) with positive sputum acid-fast bacilli smears and 38 observers equally randomized into the VOT and DOT groups (19 observers per group and n=1-5 patients per observer). The VOT group submitted videos to observers via smartphones; the DOT group followed standard procedures. An intention-to-treat analysis assessed the compliance of both the patients and the observers.
RESULTS: The VOT group had higher average compliance than the DOT group (patients: mean difference 15.2 days, 95% CI 4.8-25.6; P=.005 and observers: mean difference 21.2 days, 95% CI 13.5-28.9; P<.001). The sputum conversion rates in the VOT and DOT groups were 73% and 61.5%, respectively (P=.17).
CONCLUSIONS: Smartphone-based VOT significantly outperformed community-based DOT in ensuring compliance with tuberculosis treatment among observers. However, the study was underpowered to confirm improved compliance among patients with pulmonary tuberculosis and to detect differences in sputum conversion rates.
BACKGROUND: Thai Clinical Trials Registry (TCTR) TCTR20210624002; https://tinyurl.com/3bc2ycrh.
UNASSIGNED: RR2-10.2196/38796.

Subgroup analysis aims to identify subgroups (usually defined by baseline/demographic characteristics), who would (or not) benefit from an intervention under specific conditions. Often performed post hoc (not pre-specified in the protocol), subgroup analyses are prone to elevated type I error due to multiple testing, inadequate power, and inappropriate statistical interpretation. Aside from the well-known Bonferroni correction, subgroup treatment interaction tests can provide useful information to support the hypothesis. Using data from a previously published randomized trial where a p value of 0.015 was found for the comparison between standard and Hemopatch® groups in (the subgroup of) 135 patients who had hand-sewn pancreatic stump closure we first sought to determine whether there was interaction between the number and proportion of the dependent event of interest (POPF) among the subgroup population (patients with hand-sewn stump closure and use of Hemopatch®), Next, we calculated the relative excess risk due to interaction (RERI) and the \"attributable proportion\" (AP). The p value of the interaction was p = 0.034, the RERI was - 0.77 (p = 0.0204) (the probability of POPF was 0.77 because of the interaction), the RERI was 13% (patients are 13% less likely to sustain POPF because of the interaction), and the AP was - 0.616 (61.6% of patients who did not develop POPF did so because of the interaction). Although no causality can be implied, Hemopatch® may potentially decrease the POPF after distal pancreatectomy when the stump is closed hand-sewn. The hypothesis generated by our subgroup analysis requires confirmation by a specific, randomized trial, including only patients undergoing hand-sewn closure of the pancreatic stump after distal pancreatectomy.Trial registration: INS-621000-0760.

OBJECTIVE: The majority of mainstream antidepressants lack the promise of complete amelioration of symptoms. Other pitfalls include the latency period and side effects. These issues prompted investigations concerning the various roles of serotonin (5-HT) neurotransmissions in the etiology of depression. In this study, each study participant received vilazodone, vortioxetine, and escitalopram monotherapy for major depressive disorder (MDD) for 16 weeks. After that, the subject\'s scores on the Hamilton Depression Rating Scale (HDRS)-17 item version and the Montgomery Åsberg Depression Rating Scale (MADRS) were evaluated. In the study population, we kept track of the incidence of adverse events.
METHODS: Ninety-six patients with MDD participated in this open-label, randomized, three-arm study. Participants were allotted into three groups according to a 1:1:1 ratio and given vilazodone (20-40 mg/day), vortioxetine (5-20 mg/day), or escitalopram (10-20 mg/day) for 16 weeks. Vortioxetine and vilazodone are test medications, with escitalopram serving as the control. After the baseline visit, follow-up appointments were scheduled every four weeks. Per-protocol (PP) and intent-to-treat (ITT) populations served as means for efficacy and safety evaluations, respectively. We prospectively registered this research in the Clinical Trial Registry, India (CTRI) (2022/07/043808).
RESULTS: Out of the 134 patients we screened, 109 (81.34%) were eligible. Ninety-six (88.07%) of them completed the 16-week trial. In the PP population (n = 96), we analyzed efficacy. They had a mean age of 46.3 ± 6.2 years. At baseline, each group\'s median HDRS score was 30.0 (p = 0.964). Following 16 weeks of antidepressant therapy, these scores dropped to 15.0, 14.0, and 13.0 (p = 0.002). Baseline MADRS scores for all groups were 36.0 (p = 0.741). They had corresponding values of 20.0, 18.0, and 17.0 at 16 weeks (p < 0.001). Regarding both efficacy endpoints, the post-hoc analysis with the Bonferroni correction demonstrated statistically significant differences (p < 0.001). We performed the safety assessments within our ITT population (n = 109). Ninety-six adverse events were recorded. Nonetheless, none of them seemed serious. Still, five participants opted out because of their side effects. Vomiting and nausea were the most frequent side effects.
CONCLUSIONS: Compared to escitalopram and vilazodone, vortioxetine demonstrated a statistically significant reduction in HDRS and MADRS scores. It also had fewer and milder side effects. We recommend conducting studies involving a broader population to investigate the antidepressant effects of these medications further.