BACKGROUND: Treatment of large vessel occlusion (LVO) using mechanical thrombectomy with or without intravenous thrombolysis has demonstrated better outcomes compared to medical treatment alone. Large-bore aspiration catheters have been recently introduced. Their effectiveness and safety have not been demonstrated in a randomized trial. The SUMMIT MAX study is designed to address this question.
METHODS: SUMMIT MAX is a randomized controlled trial where the effectiveness and safety of the large-bore Monopoint Reperfusion system (Route 92 Medical, San Mateo, CA), will be compared to the currently largest available FDA-cleared aspiration thrombectomy device the AXS Vecta Aspiration system (Stryker Neurovascular, Fremont, CA). The study is a multi-center, prospective, randomized, controlled, interventional, open label clinical trial. The hypothesis is that the effectiveness measured by the recanalization rate (modified thrombolysis in cerebrovascular infarction - mTICI) and safety measured by symptomatic intracranial hemorrhage rate (sICH) of the medical monopoint reperfusion system is non-inferior to the AXS Vecta Aspiration system.
RESULTS: Up to 250 subjects are enrolled with at least 50% of subjects enrolled by US sites. The primary effectiveness endpoint is successful arterial revascularization defined as an mTICI score ≥ 2b after use of the assigned device adjudicated by an independent core lab. The primary safety endpoint is defined as sICH within 24 h (-8/+24) post-procedure. Secondary endpoints include successful arterial revascularization defined as a mTICI score ≥ 2b after use of the assigned device with or without adjunctive therapy; device-related serious adverse events; all asymptomatic hemorrhages; time from groin puncture to final angiogram; and rate of first pass effect defined as mTICI 2b after first pass with the assigned device stratified by age (≤85, ≥ 86).
CONCLUSIONS: SUMMIT MAX is a randomized controlled trial comparing the effectiveness and safety of a new large bore class of aspiration devices to the currently largest FDA-cleared aspiration device available.

BACKGROUND: Patients commonly present at hospital Emergency Departments (ED) with distress that meet criteria for a Somatic Symptom and Related Disorder (SSRD). Without access to effective treatment, risk of ongoing patient disability and further ED visits is high.
METHODS: This pilot trial used a randomized parallel group design to test the efficacy of Intensive Short-Term Dynamic Psychotherapy (ISTDP). ED patients who met criteria for SSRD were recruited. The effects of ISTDP plus medical care as usual (MCAU) were judged through comparison against 8 weeks of MCAU plus wait-list symptom monitoring (WL-SM). The primary outcome was somatic symptom at 8 weeks. Patients allocated to WL-SM could cross-over to receive ISTDP and 6-month follow-up data was collected. Baseline measures of patient attachment style and alexithymia were collected to examine vulnerabilities to somatic symptoms.
RESULTS: gov: NCT02076867.
RESULTS: Thirty-seven patients were randomized to 2 groups (ISTDP = 19 and WL-SM = 18). Multi-level modelling showed that change over time on somatic symptoms was significantly greater in the ISTDP group. Between-group differences were large at 8 weeks (Cohen\'s d = 0.94) and increased by end of treatment (Cohen\'s d = 1.54). Observed differences in symptoms of depression and illness anxiety were also large, favoring ISTDP, and effects were maintained at follow-up. Patients receiving ISTDP had reduced ED service utilization at 2-year follow-up.
CONCLUSIONS: ISTDP appears an efficacious treatment for SSRD and a larger randomized trial is justified.

OBJECTIVE: To evaluate the effect on type 2 diabetes remission of short-term intensive metabolic intervention consisting of frequent dietary, exercise and diabetes management coaching, metformin and fixed-ratio insulin degludec/liraglutide.
METHODS: In a multicentre open-label randomized controlled trial, insulin-naïve participants within 5 years of diabetes diagnosis were assigned to a 16-week remission intervention regimen or standard care, and followed for relapse of diabetes and sustained remission for an additional year after stopping glucose-lowering drugs.
RESULTS: A total of 159 participants aged 57 ± 10 years, with diabetes duration 2.6 ± 1.5 years, body mass index 33.5 ± 6.5 kg/m2, and glycated haemoglobin (HbA1c) level 53 ± 7 mmol/mol were randomized and analysed (79 intervention, 80 control). At the end of the 16-week intervention period, compared to controls, intervention participants achieved lower HbA1c levels (40 ± 4 vs. 51 ± 7 mmol/mol; p < 0.0001), and lost more weight (3.3 ± 4.4% vs. 1.9 ± 3.0%; p = 0.02). There was a lower hazard of diabetes relapse overall in the intervention group compared to controls (hazard ratio 0.63, 95% confidence interval [CI] 0.45, 0.88; p = 0.007), although this was not sustained over time. Remission rates in the intervention group were not significantly higher than in the control group at 12 weeks (17.7% vs. 12.5%, relative risk [RR] 1.42, 95% CI 0.67, 3.00; p = 0.36) or at 52 weeks (6.3% vs. 3.8%, RR 1.69, 95% CI 0.42, 6.82) following the intervention period.
CONCLUSIONS: An intensive remission-induction intervention including fixed-ratio insulin degludec/liraglutide reduced the risk of type 2 diabetes relapse within 1 year without sustained remission.

BACKGROUND: Improving survivorship for patients with cancer and frailty is a priority. We aimed to estimate whether exercise prehabilitation improves disease-free survival and return to intended oncologic treatment for older adults with frailty undergoing cancer surgery.
METHODS: We conducted a secondary analysis of the oncologic outcomes of a randomized trial of patients ≥ 60 yr of age with frailty undergoing elective cancer surgery. Participants were randomized either to a supported, home-based exercise program plus nutritional guidance or to usual care. Outcomes for this analysis were one-year disease-free survival and return to intended oncologic treatment. We estimated complier average causal effects to account for intervention adherence.
RESULTS: We randomized 204 participants (102 per arm); 182 were included in our modified intention-to-treat population and, of these participants, 171/182 (94%) had complete one-year follow up. In the prehabilitation group, 18/94 (11%) died or experienced cancer recurrence, compared with 19/88 (11%) in the control group (hazard ratio [HR], 1.25; 95% confidence interval [CI], 0.66 to 2.34; P = 0.49). Return to intended oncologic treatment occurred in 24/94 (29%) patients the prehabilitation group vs 20/88 (23%) in the usual care group (HR, 1.53; 95% CI, 0.84 to 2.77; P = 0.16). Complier average causal effects directionally diverged for disease-free survival (HR, 0.91; 95% CI, 0.20 to 4.08; P = 0.90) and increased the point estimate for return to treatment (HR, 2.04; 95% CI, 0.52 to 7.97; P = 0.30), but in both cases the CIs included 1.
CONCLUSIONS: Randomization to home-based exercise prehabilitation did not lead to significantly better disease-free survival or earlier return to intended oncologic treatment in older adults with frailty undergoing cancer surgery. Our results could inform future trials powered for more plausible effect sizes, especially for the return to intended oncologic treatment outcome.
BACKGROUND: ClinicalTrials.gov ( NCT02934230 ); first submitted 22 August 2016.
RéSUMé: CONTEXTE: L’amélioration de la survie des personnes atteintes de cancer et de fragilité est une priorité. Nous avons cherché à estimer si la préadaptation physique améliore la survie sans maladie et le retour au traitement oncologique prévu pour les personnes âgées fragiles bénéficiant d’une chirurgie du cancer. MéTHODE: Nous avons effectué une analyse secondaire des issues oncologiques d’une étude randomisée de patient·es âgé·es de 60 ans ou plus atteint·es de fragilité bénéficiant d’une chirurgie carcinologique non urgente. Nous avons randomisé les personnes participantes à un programme d’exercice à domicile accompagné de conseils nutritionnels ou à recevoir les soins habituels. Les critères d’évaluation de cette analyse étaient la survie sans maladie à un an et le retour au traitement oncologique prévu. Nous avons estimé les effets moyens causaux d’observance pour tenir compte de l’adhérence à l’intervention. RéSULTATS: Nous avons randomisé 204 participant·es (102 par bras); 182 personnes ont été incluses dans notre population modifiée en intention de traiter et, parmi ces participant·es, 171/182 (94%) ont fait l’objet d’un suivi complet à un an. Dans le groupe préadaptation, 18/94 (11%) personnes sont décédées ou ont connu une récidive du cancer, contre 19/88 (11 %) dans le groupe témoin (rapport de risque [HR], 1,25; intervalle de confiance [IC] à 95%, 0.66 à 2.34; P = 0.49). Le retour au traitement oncologique prévu a eu lieu chez 24 patient·es sur 94 (29 %) dans le groupe préadaptation vs 20/88 (23 %) dans le groupe de soins habituels (RR, 1.53; IC 95%, 0.84 à 2.77; P = 0.16). Les effets moyens causaux d’observance ont divergé directionnellement pour la survie sans maladie (RR, 0.91; IC 95%, 0.20 à 4.08; P = 0.90) et augmenté l’estimation ponctuelle du retour au traitement (RR, 2.04; IC 95%, 0.52 à 7.97; P = 0.30), mais dans les deux cas, les IC comprenaient 1. CONCLUSION: La randomisation pour la préadaptation physique à domicile n’a pas entraîné d’amélioration significative de la survie sans maladie ou de retour plus précoce au traitement oncologique prévu chez les personnes âgées fragiles bénéficiant d’une chirurgie du cancer. Nos résultats pourraient éclairer de futures études alimentées par des tailles d’effet plus plausibles, en particulier pour le critère de retour prévu au traitement oncologique. ENREGISTREMENT DE L’éTUDE: ClinicalTrials.gov ( NCT02934230 ); première soumission le 22 août 2016.

Coronavirus disease 2019 (COVID-19) vaccines reduce severe disease and mortality and may lessen transmission, measured by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load (VL). Evaluating vaccine associations in VL at COVID-19 diagnosis in 4 phase 3 randomized, placebo-controlled vaccine trials, July 2020 to July 2021, VL reductions were 2.78 log10 copies/mL (95% confidence interval [CI], 1.38-4.18; n = 60 placebo, 11 vaccine) and 2.12 log10 copies/mL (95% CI, 1.44-2.80; n = 594 placebo, 36 vaccine) for NVX-CoV2373 and mRNA-1273, respectively. Associations were not significant for AZD1222 (0.59 log10 copies/mL; 95% CI, -.19 to 1.36; n = 90 placebo, 78 vaccine) or Ad26.COV2.S (0.23 log10 copies/mL; 95% CI, -.01 to .47; n = 916 placebo, 424 vaccine). Thus, vaccines potentially decreased transmission when ancestral SARS-CoV-2 predominated. Clinical Trials Registration. NCT04470427, NCT04505722, NCT04516746, NCT04611802.

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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: To study safety, efficacy and weight loss with ADO09, a co-formulation of insulin A21G and pramlintide, in type 1 diabetes.
METHODS: A randomized, two-arm ambulatory 16-week study compared ADO09 with insulin lispro in 80 participants with type 1 diabetes. We compared changes of weight, glycated haemoglobin, glycaemic patterns during continuous glucose monitoring, and insulin doses at baseline and at the end of treatment.
RESULTS: A significant and continuing weight loss, the primary endpoint, was observed with ADO09 compared with lispro as prandial insulin. In the whole group, the weight loss with ADO09 relative to lispro was 2.1 kg. Glycaemic control was relatively good (7.7% mean glycated haemoglobin) in both groups and did not change during treatment. Prandial insulin doses were reduced by 21% in the ADO09 group, whereas basal insulin dosage was not modified. Gastrointestinal symptoms were more frequent with ADO09, but no clear difference in hypoglycaemia was observed.
CONCLUSIONS: These results extend previous observations on the efficacy and safety of this insulin/pramlintide co-formulation. They show a beneficial effect on weight, using less mealtime insulin and without increased hypoglycaemia.

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: Recent imaging studies identified a brain network associated with clinical improvement following deep brain stimulation (DBS) in Parkinson\'s disease (PD), the PD response network.
OBJECTIVE: This study aimed to assess the impact of neuromodulation on PD motor symptoms by targeting this network noninvasively using multifocal transcranial direct current stimulation (tDCS).
METHODS: In a prospective, randomized, double-blinded, crossover trial, 21 PD patients (mean age 59.7 years, mean Hoehn & Yahr [H&Y] 2.4) received multifocal tDCS targeting the a-priori network. Twenty-minute sessions of tDCS and sham were administered on 2 days in randomized order. Movement Disorder Society-Unified Parkinson\'s Disease Rating Scale-Part III (MDS-UPDRS-III) scores were assessed.
RESULTS: Before intervention, MDS-UPDRS-III scores were comparable in both conditions (stimulation days: 37.38 (standard deviation [SD] = 12.50, confidence interval [CI] = 32.04, 42.73) vs. sham days: 36.95 (SD = 13.94, CI = 30.99, 42.91), P = 0.63). Active stimulation resulted in a reduction by 3.6 points (9.7%) to 33.76 (SD = 11.19, CI = 28.98, 38.55) points, whereas no relevant change was observed after sham stimulation (36.43 [SD = 14.15, CI = 30.38, 42.48], average improvement: 0.5 [1.4%]). Repeated-measures analysis of variance (ANOVA) confirmed significance (main effect of time: F(1,20)=4.35, P < 0.05). Tukey\'s post hoc tests indicated MDS-UPDRS-III improvement after active stimulation (t [20] = 2.9, P = 0.03) but not after sham (t [20] = 0.42, P > 0.05). In a subset of patients that underwent DBS surgery later, their DBS response correlated with tDCS effects (R = 0.55, P(1) = 0.04).
CONCLUSIONS: Noninvasive, multifocal tDCS targeting a DBS-derived network significantly improved PD motor symptoms. Despite a small effect size, this study provides proof of principle for the successful noninvasive neuromodulation of an invasively identified network. Future studies should investigate repeated tDCS sessions and their utility for screening before DBS surgery. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.