Pilot Randomized Clinical Trial Research Articles

Non-invasive Brain Stimulation Can Reduce Unilateral Spatial Neglect after Stroke: ELETRON Trial.

Rehabilitation top-down techniques based on brain stimulation present variable outcomes in unilateral spatial neglect (USN) after stroke. This study aimed to examine the effects of physical therapy after anodal and cathodal transcranial direct current stimulation (A-tDCS and C-tDCS, respectively) to improve visuospatial and functional impairments in individuals with USN after stroke. This double-blinded, pilot randomized clinical trial enrolled patients with USN after ischemic stroke. Randomization was stratified according to the Behavior Inattention Test-Conventional (BIT-C) and Catherine Bergego Scale (CBS). Outpatient physical therapy was conducted for 7.5 weeks after 20 minutes of tDCS. The primary outcome was the USN degree evaluated by the BIT-C. Secondary outcomes were the difference in CBS score, stroke severity (National Institutes of Health Stroke Scale [NIHSS]), disability (modified Rankin Scale), autonomy (Barthel Index, Functional Independence Measure), and quality of life (EuroQol Group 5-Dimension Self-Report Questionnaire). Outcomes were analyzed using an analysis of covariance model corrected by age, baseline NIHSS, and baseline BIT-C. Pairwise post hoc comparisons were performed using Bonferroni correction. In the primary outcomes, A-tDCS led to greater improvement in BIT-C after intervention (mean difference [MD]= 18.4, 95% confidence interval [CI]= 3.9-32.8, p= 0.008) compared to sham. However, no significant differences were observed between A-tDCS and C-tDCS (MD=13.9, 95% CI=-0.3 to 28.1, p= 0.057), or C-tDCS and sham (MD=4.5, 95% CI=-9.7 to 18.8, p= 0.99). There were no significant differences between groups in terms of secondary outcomes. A-tDCS associated with physical therapy can decrease the severity of USN after stroke. However, these preliminary findings must be confirmed by collecting additional evidence in a larger phase 3 trial. ANN NEUROL 2022;92:400-410.

Effect of Virtual Reality on Pain Management and Opioid Use Among Hospitalized Patients After Head and Neck Surgery

Optimal postoperative pain management is challenging. Virtual reality (VR) provides immersive, 3-dimensional experiences that may improve pain control and reduce reliance on pharmacologic pain management. To evaluate use of VR on postoperative pain management after head and neck surgery. This prospective, pilot randomized clinical trial was conducted at Oregon Health & Science University from July 2020 to October 2021 and included patients hospitalized after major head and neck surgery. Similar 15-minute interactive gaming experiences (Angry Birds) using an Oculus Quest VR headset (VR intervention) or a handheld smartphone device (control). The primary outcome was postintervention pain reduction. Pain scores were obtained preintervention, immediately after intervention, and then hourly for 4 hours. Secondary outcomes included changes in opioid use, measured as milligram morphine equivalents (MMEs), and patient experiences with their intervention using 5-point Likert scales. Of the 30 patients randomized for inclusion, the final population included 14 patients in the VR cohort and 15 patients in the control cohort; the majority of patients were male (26 of 29 [90%]), and the mean (SD) age was 58.3 (13.8) years. After outlier removal, there were clinically meaningful reductions in postintervention pain among patients in the VR group immediately after intervention (mean difference, -1.42; 95% CI, -2.15 to -0.70; d = 1.50), at 1 hour (mean difference, -0.86; 95% CI, -1.90 to 0.14; d = 0.67), 2 hours (mean difference, -1.07; 95% CI, -2.30 to 0.14; d = 0.69), and 3 hours (mean difference, -1.36; 95% CI, -2.80 to 0.13; d = 0.71) compared with patients in the control group. Patients in the VR group also demonstrated reductions in 4-hour postintervention opioid use compared with 4-hour preintervention opioid use (mean difference, -9.10 MME; 95% CI, -15.00 to -1.27 MME; d = 0.90) and 8-hour postintervention opioid use compared with 8-hour preintervention opioid use (mean difference, -14.00 MME; 95% CI, -25.60 to -2.40 MME; d = 0.94). There were no meaningful differences in subjective patient experiences with their respective interventions. In this randomized clinical trial, VR reduced pain scores and opioid use compared with a control intervention. Virtual reality may be a useful adjunct for postoperative pain management after head and neck surgery. ClinicalTrials.gov Identifier: NCT04464304.

Comparison of Augmented Reality-assisted and Instructor-assisted Cardiopulmonary Resuscitation: A Simulated Randomized Controlled Pilot Trial

BackgroundA trained lay rescuer is the most important determinant of survival from sudden cardiac arrest. Augmented Reality (AR) device may represent a powerful instrument for CPR assistance and self-training especially during the COVID-19 pandemic. MethodsA prospective, parallel, 1:1 pilot randomized clinical trial was designed. An AR CPR app was developed and 28 participants were randomly allocated into AR-assisted group and instructor-assisted group. Acceptability, usability, and mean per minute/per cycle chest compression depth, rate and accuracy were measured. ResultsThe mean scores for acceptability and usability were all rated good in each group. Comparing real-time AR-assisted CPR to instructor-assisted CPR, the mean difference of compression depth was 0.18 (95% CI: -0.18-0.53) cm and rate was -1.58 (95% CI: -6.11-2.95) min-1. Comparing AR self-training to instructor training, the AR group was not significantly different between two groups regarding both compression depth, rate and accuracy (p > .05). ConclusionWe found that the AR CPR app was an acceptable and usable tool both in real-time-assisted CPR and self-training CPR.

Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial.

BackgroundYoung people who inject drugs (PWID) have high hepatitis C virus (HCV) incidence and low treatment initiation rates. Novel, simplified care models need to be developed to engage, treat, and cure hard-to-reach patient populations, such as young PWID. We present final data from the randomized pilot clinical trial “HCV-Seek Test and Rapid Treatment” for curing HCV in young PWID.MethodsParticipants were recruited from the community and eligible if they were 18–29 years of age, HCV antibody-positive, treatment naive, and had injected drugs in the past 30 days. Participants were randomized 1:1 to “Rapid Treatment or Usual Care”. Participants randomized to Rapid Treatment received same-day medical evaluation, confirmatory and baseline laboratory testing, and a 7-day starter pack of sofosbuvir/velpatasvir at a syringe service program (SSP). Participants in “Usual Care” received same-day HCV confirmatory testing at the SSP and, if positive, facilitated referral to local providers. The primary endpoint was sustained virologic response at 12 weeks (SVR12) in HCV ribonucleic acid (RNA)+ participant.ResultsForty-seven HCV antibody-positive participants were enrolled, and 25 participants had confirmed HCV and were included in the modified intention to treat analysis, with 9 of 14 (64%) of the Rapid Treatment arm and 1 of 11 (9.1%) of the Usual Care arm achieving a confirmed SVR12 (P = .01).ConclusionsAmong young HCV RNA+ PWID, significantly higher rates of cure were achieved using the Rapid Treatment model compared with facilitated referral. Providing easy access to HCV treatment for young PWID in low-threshold settings and initiating HCV treatment quickly appears to be a promising strategy for treating this hard-to-reach population.

Effects of Acute Triiodothyronine Treatment in Patients with Anterior Myocardial Infarction Undergoing Primary Angioplasty: Evidence from a Pilot Randomized Clinical Trial (ThyRepair Study).

Background: Thyroid hormone has a differential action on healthy and ischemic heart. Triiodothyronine (T3) administration improved postischemic cardiac function while it limited apoptosis in experimentally induced ischemia. Thus, the present study investigated the potential effects of acute liothyronine (LT3) treatment in patients with anterior myocardial infarction. Methods: This study is a pilot, randomized, double-blind, placebo-controlled trial (ThyRepair study). We randomized 52 patients and analyzed data from 37 patients (n = 16 placebo and n = 21 LT3), per prespecified per protocol analysis. We excluded three patients who had died of cardiovascular causes (one in placebo and two in LT3 arm), four with small infarct size below a pre-specified threshold (in the placebo arm), and the rest, who lacked follow-up data. LT3 treatment started after stenting as an intravenous (i.v.) bolus injection of 0.8 μg/kg of LT3 followed by a constant infusion of 0.113 μg/kg/h i.v. for 48 hours. All patients had cardiac magnetic resonance (CMR) at hospital discharge and 6 months follow-up. The primary end point was CMR left ventricular (LV) ejection fraction (LVEF) and secondary endpoints were LV volumes, infarct volume (IV), and safety. Results: The CMR LVEF% at 6 months was 53.6 ± 9.5 for the LT3-treated group and 48.6 ± 11 for placebo, p = 0.15. Acute LT3 treatment resulted in a significantly lower LV end-diastolic volume index (92.2 ± 16.8 mL/m2 vs. 107.5 ± 22.2, p = 0.022) and LV systolic volume index (47.5 ± 13.9 mL/m2 vs. 61.3 ± 21.7, p = 0.024) at hospital discharge, but not at 6 months. There was no statistically significant difference in CMR IV at hospital discharge between the groups (p = 0.24). CMR IV tended to be lower in the LT3-treated group at 6 months (18.7 ± 9.5 vs. 25.9 ± 11.7, in placebo, p = 0.05). Serious, life-threatening events related to LT3 treatment were not observed. A tendency for an increased incidence of atrial fibrillation (AF) was found in the LT3 group during the first 48 hours (19% for T3 group vs. 5% for placebo, p = 0.13). Conclusion: This pilot randomized, placebo-controlled trial study suggests potential favorable effects (acute cardiac dilatation and 6-month IV) as well as potential concerns regarding a higher risk of AF after LT3 administration early after myocardial infarction, which should be tested in a larger scale study.

Post-operative pain after vital pulpotomy of primary molars using allium sativum oil versus mineral trioxide aggregate

Aim: To evaluate clinical and radiographic performance of Allium Sativum oil dressed in Zinc Oxide versus Mineral trioxide aggregate as pulp dressing agent in pulpotomized lower primary molar teeth. Methodology: This randomized pilot clinical trial included 30 lower primary molars indicated for vital pulpotomy and randomly allocated into two equal groups (n=15): Group (I): pulpotomy using A. Sativum oil dressed in ZnO and Group (II): pulpotomy using Mineral trioxide aggregate as pulpotomy agent. All molars were covered with stainless steel crowns and clinical and radiographic assessment was done at 3, 6, 9 and 12 months interval by help of predetermined criteria. Results: Overall clinical success rate of Group (I) and Group (II) at the end of 12 months follow-up was (93.3%) and (100.0%) respectively. There was no statistical significance difference between two groups regarding overall clinical success rate. The overall radiographic success rate at the end of 12 months was (40.0%) and (100.0%) respectively. There was a statistical significant difference regarding overall radiographic success rate at 9 and 12 months follow-up. The overall success rate of Group (I) and Group (II) at the end of 12 months was (40.0%) and (100.0%) showing a statistically significant difference between the two groups.

Non–absorbable versus Absorbable Sutures for Medial Rectus Advancement in Consecutive Exotropia, a Pilot Randomized Clinical Trial

ABSTRACT Purpose To compare non–absorbable and absorbable sutures for medial rectus advancement in consecutive exotropia Methods In a pilot randomized clinical trial, 40 subjects with consecutive exotropia >15 PD that underwent unilateral medial rectus advancement with or without resection were randomly assigned to two groups: using non-absorbable (polyester) suture in the non-absorbable group and absorbable (vicryl) suture in the absorbable group. The success rate was defined as the final postoperative angle of deviation <10 PD. Results Thirty-three patients (18 in the non-absorbable and 15 in the absorbable group) had completed the study. At last follow-up, the distance deviation improved from 29.2 ± 15.5 to 7.6 ± 7.9 in the non-absorbable group and from 25.9 ± 8.4 to 8.1 ± 10.7 in the absorbable group. The near deviation improved from 31.4 ± 15.9 to 7.2 ± 8.0 in the non-absorbable and from 29.0 ± 7.6 to 6.8 ± 11.9 in the absorbable group. The amount of the final correction of the distance and near deviation was not statistically different between the groups (P = .80 and P = .99, respectively). At the final examination, the exoshifts for distance and near were not statistically different between 2 groups (p = .61 and 0.54, respectively). At the final examination, the success was obtained in 12 patients (66.7%) and 8 patients (53.3%) in the non-absorbable and absorbable group, respectively (p = .73). Conclusion In our study, there was no statistical difference in success rate or exoshift between non-absorbable and absorbable sutures. So, considering local inflammation induced by non-absorbable sutures in some cases, the absorbable sutures can be an appropriate option for the treatment of consecutive exotropia.

Identifying Pain Modulating Brain Mechanisms After Qigong Practice For Pain Reduction In Adults With Chronic Low Back Pain: A Proof Of Concept Study

Research Objectives Twenty million Americans suffer from chronic low back pain (cLBP). Due to the limited success of medications, mind and body approaches that incorporate mindful movement have potential for cLBP because movement is often impaired. Qigong is accessible due to its gentle movements and dual focus on breathing and body awareness. Our previous research and others found that two brain areas (parietal operculum, insula) are important brain areas for body awareness and pain perception. We determined the proof of concept in demonstrating pain-related brain function changes after Qigong or exercises concurrent with changes in pain and associated outcomes. Design Randomized pilot clinical trial. Setting University of Minnesota with remote intervention. Participants Our goal is to enroll 32 participants. To date 12 participants (2 men, 10 women, average age 45.5 years) were randomized into the Qigong practice (n=6) or P.Volve (n=6) group and completed the study. Interventions The Qigong group practiced the “5 Elements Qigong Healing”. The active comparison group received low-impact exercises designed by P.Volve, which focuses on core strengthening and stabilization. Both groups received a video link to practice at home with 40min/session videos, 3x/week for 12 weeks. Main Outcome Measures We performed 3 fMRI tasks: mental focus on low back pain; an imagined Qigong movement; shape discrimination (MRI-compatible robot). Our patient self-reported measures were pain intensity levels/week; functional tasks, Modified Roland-Morris disability questionnaire, 4 body awareness scales, proprioceptive acuity, core strength, and balance. All assessments were performed before and after the 12-week interventions. Results In the MRI, parietal operculum activation reduced during the Qigong task (Qigong group) and during the mental focus on low back pain task (P.Volve group). These brain function changes were seen alongside within-group improvement in our self-reported measures (effect-sizes d=1.1-2.0), and in strength and balance (d=0.76-1.68). Conclusions Our observations so far support our proof of concept and presents the first step to understanding the brain mechanisms of alternative treatments that improve dysfunctional pain processing in the brain to reduce LBP. Author(s) Disclosures No conflict of interest. Twenty million Americans suffer from chronic low back pain (cLBP). Due to the limited success of medications, mind and body approaches that incorporate mindful movement have potential for cLBP because movement is often impaired. Qigong is accessible due to its gentle movements and dual focus on breathing and body awareness. Our previous research and others found that two brain areas (parietal operculum, insula) are important brain areas for body awareness and pain perception. We determined the proof of concept in demonstrating pain-related brain function changes after Qigong or exercises concurrent with changes in pain and associated outcomes. Randomized pilot clinical trial. University of Minnesota with remote intervention. Our goal is to enroll 32 participants. To date 12 participants (2 men, 10 women, average age 45.5 years) were randomized into the Qigong practice (n=6) or P.Volve (n=6) group and completed the study. The Qigong group practiced the “5 Elements Qigong Healing”. The active comparison group received low-impact exercises designed by P.Volve, which focuses on core strengthening and stabilization. Both groups received a video link to practice at home with 40min/session videos, 3x/week for 12 weeks. We performed 3 fMRI tasks: mental focus on low back pain; an imagined Qigong movement; shape discrimination (MRI-compatible robot). Our patient self-reported measures were pain intensity levels/week; functional tasks, Modified Roland-Morris disability questionnaire, 4 body awareness scales, proprioceptive acuity, core strength, and balance. All assessments were performed before and after the 12-week interventions. In the MRI, parietal operculum activation reduced during the Qigong task (Qigong group) and during the mental focus on low back pain task (P.Volve group). These brain function changes were seen alongside within-group improvement in our self-reported measures (effect-sizes d=1.1-2.0), and in strength and balance (d=0.76-1.68). Our observations so far support our proof of concept and presents the first step to understanding the brain mechanisms of alternative treatments that improve dysfunctional pain processing in the brain to reduce LBP.

Effectiveness of the Tailored, Early Comprehensive Rehabilitation Program (t-ECRP) based on ERAS in improving the physical function recovery for patients following minimally invasive esophagectomy: a prospective randomized controlled trial

BackgroundPerioperative rehabilitation management is essential to enhanced recovery after surgery (ERAS). Limited reports, however, have focused on quantitative, detailed early activity plans for patients receiving minimally invasive esophagectomy (MIE). The purpose of this research was to estimate the effectiveness of the Tailored, Early Comprehensive Rehabilitation Program (t-ECRP) based on ERAS in the recovery of bowel and physical functions for patients undergoing MIE.MethodsIn this single-blind, 2-arm, parallel-group, randomized pilot clinical trial, patients admitted to the Affiliated Cancer Hospital of Zhengzhou University from June 2019 to February 2020 were selected and randomly assigned to an intervention group (IG) or a control group (CG). The participants in the IG received medical care based on the t-ECRP strategy during perioperative period, and participants in the CG received routine care. The recovery of bowel and physical functions, readiness for hospital discharge (RHD), and postoperative hospital stay were evaluated on the day of discharge.ResultsTwo hundred and fifteen cases with esophageal cancer (EC) were enrolled and randomized to the IG (n = 107) or CG (n = 108). The mean age was 62.58 years (SD 9.07) and 71.16% were male. For EC, 53.49% were mid-location cancers and 79.07% were classified as pathological stage II and III cancers. There were no significant differences between the two groups in terms of demographic and clinical characteristics and baseline physical functions. Participants in the IG group presented significantly shorter lengths of time to first flatus (P < 0.001), first postoperative bowel movement (P = 0.024), and for up and go test (P < 0.001), and lower scores of frailty (P < 0.001). The analysis also showed that participants in the IG had higher scores of RHD and shorter lengths of postoperative stay than in the CG (P < 0.05).ConclusionsThe t-ECRP appears to improve bowel and physical function recovery, ameliorate RHD, and shorten postoperative hospital stay for patients undergoing MIE. Clinicians should consider prescribing quantitative, detailed, and individualized early activity plans for these patients.Trial registrationClinicalTrials.gov (Identifier: NCT01998230)

A Pilot Randomized Clinical Trial of a Novel, Culturally Adapted, Trauma-Focused Cognitive-Behavioral Intervention for War-Related PTSD in Iraqi Women

Trauma-focused cognitive-behavioral therapy (TF-CBT), broadly, is one of the leading evidence-based treatments for youth with posttraumatic stress disorder (PTSD). Generally, few culturally adapted TF-CBT interventions have been examined among war trauma-affected populations in low- and middle-income countries. Using a randomized clinical trial design, a total of 48 war trauma-exposed women in Iraq, Mage (SD) = 32.91 (5.33), with PTSD were randomly assigned to either TF-CBT or wait-list control (WLC) conditions. The intervention group received 12 individual weekly sessions of a culturally adapted TF-CBT intervention. Significant reductions in PTSD symptom severity were reported by women in the TF-CBT condition from pre- to posttreatment. Women in the TF-CBT condition reported significantly greater reductions in PTSD symptoms compared to WLC at 1-month follow-up. Additionally, levels of depression, anxiety, stress, and use of maladaptive emotion regulation strategies were significantly lower in the TF-CBT condition at posttreatment and 1-month follow-up, compared to the WLC condition. Women in the TF-CBT condition also reported significant improvements in various domains of quality of life at posttreatment and 1-month follow-up. This clinical trial provides preliminary cross-cultural support for the feasibility and efficacy of TF-CBT for the treatment of PTSD symptoms among women in non-Western cultures. Future directions and study limitations are discussed.

Balloon-Expandable Cheatham-Platinum Stents Versus Self-Expandable Nitinol Stents in Coarctation of Aorta: ARandomized Controlled Trial.

This study sought to compare the safety and efficacy of the balloon-expandable stent (BES) and the self-expandable stent (SES) in the endovascular treatment of coarctation of aorta. Coarctoplasty with stents has conferred promising results. Although several nonrandomized studies have approved the safety and efficacy of the BES and the SES, nohigh-quality evidence exists for this comparison. In the present open-label, parallel-group, blinded endpoint randomized pilot clinical trial, adult patients with de novo native aortic coarctation were randomized into Cheatham-platinum BES and uncovered nitinol SES groups. The primary outcome of the study was a composite of procedural and vascular complications. The secondary outcomes of the study consisted of the incidence of aortic recoarctation, thoracic aortic aneurysm/pseudoaneurysm formation, andresidual hypertension at a 12-month follow-up. Among 105 patients who were screened between January 2017 and December 2019, 92 eligible patients (32women [34.8%]) with a median age of 30 years (IQR: 20-36 years) were randomized equally into the BES and SES groups. The composite of procedural and vascular complications occurred in 10.9% of the BES group and2.2% of the SES group (odds ratio: 0.18; 95% CI: 0.02-1.62; P=0.20). Aortic recoarctation occurred in 5 patients (5.4%), 3 patients (6.5%) in the BES group and 2 patients (4.3%) in the SES group (odds ratio: 0.65; 95% CI: 0.10-4.09; P=0.64). Only 1 patient (1.1%) was complicated by aortic pseudoaneurysm. Hypertension control was achieved in 50% of the study population, with an equal distribution in the 2 study groups at the12-month follow-up. Both the BES and the SES were safe and effective in the treatment of native coarctation.

Abstract 108: Home Blood Pressure Telemonitoring-enhanced Versus Usual Post-acute Stroke Care In An Underserved Setting: The Telehealth After Stroke Care Pilot Randomized Clinical Trial

Introduction: Hypertension is the most important modifiable risk factor for recurrent stroke. However, it remains poorly controlled after stroke, especially among Black and Hispanic patients. Black and Hispanics have a higher prevalence of uncontrolled BP and limited access to care. Interventions that promote equitable access are needed to improve outcomes. Aim: We tested whether a randomized trial of post-acute stroke care that integrates nurse-supported home BP telemonitoring, tailored infographics, and video visits with a multidisciplinary team including pharmacy (Telehealth After Stroke Care (TASC intervention) was feasible. Methods: Acute stroke patients with hypertension were randomized prior to discharge to usual care or TASC. Usual care patients received a video visit with primary care at 1-2 weeks and stroke specialist at 6 and 12 weeks after discharge. TASC patients received a tablet that wirelessly transmits BP data to the electronic health record, supported by remote telehealth nurse monitoring along with BP infographics, developed through community participatory design, at first visit and pharmacist visits. Outcomes included recruitment feasibility, visit adherence, and retention. Generalized linear modeling was used to evaluate within-patient home BP change. Results: Of 67 eligible patients, 6 were discharged before recruitment, 8 refused and 3 engaged in other studies. Fifty enrolled patients included 44% Hispanic, 32% Black and 36% women with mean age 64.3 (±14.0) yrs. About half had ≤ a high school education and 30% had commercial insurance. Baseline SBP was similar in TASC (140 ± 19 mmHg) vs. usual care (142 ± 19 mmHg). Retention rate was higher in TASC vs. usual care (84% vs 64%, p=0.11). Adherence to video visits was also higher in TASC (91% vs 75%, p=0.14). SBP control was better in TASC (76% vs. 25%, p&lt;0.01). At 12 weeks, home SBP declined by 16 ± 19 mmHg from baseline in TASC vs increased by 3 ± 24 mmHg (p&lt;0.01) in usual care. SBP control in Black patients improved from 40% at baseline to 100% in TASC vs from 14% to 29% in usual care. Conclusion: Enhancing post-acute stroke care with home BP telemonitoring is a promising approach to improving hypertension control in an underserved setting that should be tested in a definitive randomized trial.

Feasibility and Acceptability of Online Opioid Overdose Education and Naloxone Distribution: Study Protocol and Preliminary Results from a Randomized Pilot Clinical Trial

Feasibility and Acceptability of Online Opioid Overdose Education and Naloxone Distribution: Study Protocol and Preliminary Results from a Randomized Pilot Clinical Trial

911. Rapid Hepatitis C Treatment Initiation in Young People Who Inject Drugs: Final Results from the HCV-Seek, Test and Rapid Treatment (HCV-ST&amp;RT) Randomized Pilot Clinical Trial

BackgroundYoung people who inject drugs (PWID) have higher HCV incidence and lower treatment initiation rates compared to their older peers. Novel, simplified care models need to be developed to engage, treat and cure hard to reach patient populations, such as young PWID.MethodsWe present final data from the randomized pilot clinical trial HCV-Seek Test & Rapid Treatment (HCV-ST&RT) for curing HCV in young PWID. Eligible participants were 18-29 years of age, HCV Ab+, treatment naïve, and had injected drugs in the past 30 days. Participants were randomized 1:1 to the Rapid Treatment or Usual Care arm. Participants randomized to Rapid Treatment received a same-day medical evaluation, confirmatory and baseline lab testing, and 7-day starter pack of sofosbuvir/velpatasvir. Participants in Usual Care received same-day HCV confirmatory testing and, if positive, facilitated referral to local providers. The primary endpoint was sustained virologic response (SVR12) in RNA+ participant within 12 months of enrollment. ResultsAmong 47 eligible participants, 38 were enrolled and randomized. 14/18 in the Rapid Treatment arm and 11/20 in the Usual Care arm were confirmed HCV RNA+ and included in the intention-to-treat analysis. Demographics of the RNA+ participants were similar in the two arms with a mean age of 26 years; 24% women; 36% Hispanic and 4% non-Hispanic black. At baseline 24% were homeless, 52% received medication for opioid use disorder in the prior 90 days, and participants injected a median of 20 of the last 30 days. In the intention-to-treat analysis, 9/14 (64%) of the Rapid Treatment arm and 2/11 (18%) of the Usual Care arm had confirmed SVR12 (p=0.042). Of the 5 participants in the Rapid Treatment arm who did not achieve SVR12, 1 had treatment failure, 1 never started DAA therapy, 1 had an on-treatment response with pending SVR12 confirmation, and 2 were lost to follow-up. ConclusionAmong young HCV RNA+ PWID, significantly higher rates of cure were achieved using the Rapid Treatment model with same day, low-threshold, simplified HCV care compared to facilitated referral. Meeting young PWID where they’re at and initiating HCV treatment ‘in the moment’ without the need for repeat visits appears to be a promising strategy for treating this hard to reach population.Disclosures Benjamin Eckhardt, MD, MS, Gilead Sciences (Grant/Research Support) Shashi Kapadia, MD, Gilead Sciences Inc (Grant/Research Support) Kristen Marks, MD, Gilead Sciences (Grant/Research Support)

Fast vs. ultraslow thrombolytic infusion regimens in patients with obstructive mechanical prosthetic valve thrombosis: a pilot randomized clinical trial.

Thrombolysis is an alternative to surgery for mechanical prosthetic valve thrombosis (MPVT). Randomized clinical trials have yet to test the safety and efficacy of a proposed ultraslow thrombolytic infusion regimen. This single-centre, open-label, pilot randomized clinical trial randomized adult patients with acute obstructive MPVT to an ultraslow thrombolytic regimen [25mg of recombinant tissue-type plasminogen activator (rtPA) infused in 25h] and a fast thrombolytic regimen (50mg of rtPA infused in 6h). If thrombolysis failed, a repeated dose of 25mg of rtPA for 6h was administered in both groups up to a cumulative dose of 150mg or the occurrence of a complication. The primary outcome was a complete MPVT resolution (&gt;75% fall in the obstructive gradient by transthoracic echocardiography, &lt;10° limitation in opening and closing valve motion angles by fluoroscopy, and symptom improvement). The key safety outcome was a Bleeding Academic Research Consortium type III or V major bleeding. Overall, 120 patients, including 63 (52.5%) women, at a mean age of 36.3±15.3years, were randomized. Complete thrombolysis success was achieved in 51 patients (85.0%) in the ultraslow-regimen group and 47 patients (78.3%) in the fast-regimen group [odds ratio 1.58; 95% confidence interval (CI) 0.25-1.63; P = 0.34]. One case of transient ischaemic attack and three cases of intracranial haemorrhage (absolute risk difference -6.6%; 95%CI -12% -0.3%; P = 0.07) were observed only in the fast-regimen group. The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials.

ASO Visual Abstract: Multi-modal Prehabilitation During Neoadjuvant Therapy Before Esophagogastric Cancer Resection: Effect on Cardiopulmonary Exercise Test Performance, Muscle Mass, and Quality of Life—A Pilot Randomized Clinical Trial

ASO Visual Abstract: Multi-modal Prehabilitation During Neoadjuvant Therapy Before Esophagogastric Cancer Resection: Effect on Cardiopulmonary Exercise Test Performance, Muscle Mass, and Quality of Life—A Pilot Randomized Clinical Trial

Multimodal Prehabilitation During Neoadjuvant Therapy Prior to Esophagogastric Cancer Resection: Effect on Cardiopulmonary Exercise Test Performance, Muscle Mass and Quality of Life-A Pilot Randomized Clinical Trial.

Neoadjuvant therapy reduces fitness, muscle mass, and quality of life (QOL). For patients undergoing chemotherapy and surgery for esophagogastric cancer, maintenance of fitness is paramount. This study investigated the effect of exercise and psychological prehabilitation on anaerobic threshold (AT) at cardiopulmonary exercise testing (CPET). Secondary endpoints included peak oxygen uptake (peak VO2), skeletal muscle mass, QOL, and neoadjuvant therapy completion. This parallel-arm randomized controlled trial assigned patients with locally advanced esophagogastric cancer to receive prehabilitation or usual care. The 15-week program comprised twice-weekly supervised exercises, thrice-weekly home exercises, and psychological coaching. CPET was performed at baseline, 2weeks after neoadjuvant therapy, and 1week preoperatively. Skeletal muscle cross-sectional area at L3 was analyzed on staging and restaging computed tomography. QOL questionnaires were completed at baseline, mid-neoadjuvant therapy, at restaging laparoscopy, and postoperatively at 2weeks, 6weeks and 6months. Fifty-four participants were randomized (prehabilitation group, n=26; control group, n=28). No difference in AT between groups was observed post-neoadjuvant therapy. Prehabilitation resulted in an attenuated peak VO2 decline {-0.4 [95% confidence interval (CI) -0.8 to 0.1] vs. -2.5 [95% CI -2.8 to -2.2] mL/kg/min; p=0.022}, less muscle loss [-11.6 (95% CI -14.2 to -9.0) vs. -15.6 (95% CI -18.7 to -15.4) cm2/m2; p=0.049], and improved QOL. More prehabilitation patients completed neoadjuvant therapy at full dose [prehabilitation group, 18 (75%) vs. control group, 13 (46%); p=0.036]. No adverse events were reported. This study has demonstrated some retention of cardiopulmonary fitness (peak VO2), muscle, and QOL in prehabilitation subjects. Further large-scale trials will help determine whether these promising findings translate into improved clinical and oncological outcomes. Trial Registration ClinicalTrials.gov NCT02950324.

Mindfulness meditation training effects on quality of life, immune function and glutathione metabolism in service healthy female teachers: A randomized pilot clinical trial

BackgroundDespite the crucial role of educators in encourage students' academic learning, addressing educator stress inside the classroom remains a significant challenge in the educational context. Mindfulness Meditation training (MM) has been recommended as an environmental enrichment strategy in schools to help teachers cope with stress and cultivating a state of awareness in daily life. Although studies have shown that MM can improve immune system dynamics the biological mechanism underlying glutathione metabolism in a healthy human is unclear ObjectiveThe purpose of this study was to determine whether MM training benefits psychological and behavioral response, immunological functions and glutathione metabolism in service healthy female teachers from public schools MethodsWe randomly assigned 76 teachers to an 8-week Mindfulness-Based Health Program for Educators (MBHPEduca) or Neuroscience for Education program (Neuro-Educa; active control group). Using the quality of life as our primary outcome, perceived stress, negative affectivity, and resilience as our secondary outcome, and pro-inflammatory cytokines and glutathione levels as our third outcome at baseline and post-intervention that occurred in public schools. Blood samples were collected for the measurement of three proinflammatory markers, including interleukin-1β (IL-1β), interleukin-6 (IL-6), and interleukin-8 (IL-8) and three GSH metabolism, including Cysteine (Cys), Homocysteine (HCys) and GSH were conducted at pre-and post-intervention, with selfreported assessments over time. Treatment effects were analyzed using generalized estimating equations (GEE) with to intention to treat ResultsWe observed statistically significant improvements to the MBHP-Educa group compared to active control in perceived stress, resilience, positive and negative affect, and quality of life after 8-weeks MM (p ​< ​0.0001). Further, the MBHP-Educa group exhibited lower circulating IL-6 production accompanied by high circulating GSH, and Cys (p ​< ​0.0001). Additional analyses indicated that enhancing quality of life through mindfulness meditation training was mediated by reducing perceived stress and serum levels of IL- 6 and increasing resilience and teachers ‘plasma GSH levels ConclusionsThe present study is a pilot trial with low-power and provides preliminary evidence that mindfulness meditation training help teachers to cope with stress in the school environment with an impact on the quality of life, immune function, and glutathione metabolism.

A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis.

Single-center, double-blind, placebo-controlled randomized pilot clinical trial (NCT03454087). Tertiary-care medical center in Pittsburgh, PA. Critically ill adult patients within 48 hours of sepsis diagnosis and with established enteral access. Participants were randomized 1:1 to receive a continuous water (placebo) or enteral dextrose infusion (50% dextrose; 0.5 g/mL) at 10 mL per hour for 24 hours. We randomized 58 participants between June 2018 and January 2020 (placebo: n = 29, dextrose: n = 29). Protocol adherence was high with similar duration of study infusion in the placebo (median duration, 24 hr [interquartile range, 20.9-24 hr]) and dextrose (23.9 hr [23-24 hr]) groups (p = 0.59). The primary outcome of circulating interleukin-6 at end-infusion did not differ between the dextrose (median, 32 pg/mL [19-79 pg/mL]) and placebo groups (24 pg/mL [9-59 pg/mL]; p = 0.13) with similar results in other measures of the systemic host immune response. Enteral dextrose increased circulating glucose-dependent insulinotropic peptide (76% increase; 95% CI [35-119]; p < 0.01) and insulin (53% [17-88]; p < 0.01) compared with placebo consistent with preclinical studies, but also increased blood glucose during the 24-hour infusion period (153 mg/dL [119-223] vs 116 mg/dL [91-140]; p < 0.01). Occurrence of emesis, ICU and hospital length of stay, and 30-day mortality did not differ between the placebo and enteral dextrose groups. Early infusion of low-level enteral dextrose in critically ill septic patients increased circulating levels of insulin and the incretin hormone glucose-dependent insulinotropic peptide without decreasing systemic inflammation.

Enhancing Cognition in Older Persons with Depression or Anxiety with a Combination of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS): Results of a Pilot Randomized Clinical Trial.

ObjectivesIndividuals with subjective memory complaints and symptoms of depression and/or anxiety are at high risk for further cognitive decline, and possible progression to dementia. Low-burden interventions to help slow or prevent cognitive decline in this high-risk group are needed. The objective of this study is to assess the feasibility of combining Mindfulness-Based Stress Reduction (MBSR) with transcranial direct current stimulation (tDCS) to increase putative benefits of MBSR for cognitive function and everyday mindfulness in depressed or anxious older adults with subjective cognitive decline.MethodsWe conducted a two-site pilot double-blind randomized sham-controlled trial, combining active MBSR with either active or sham tDCS. The intervention included weekly in-class group sessions at the local university hospital and daily at-home practice. Anodal tDCS was applied for 30 min during MBSR meditative practice, both in-class and at-home.ResultsTwenty-six individuals with subjective cognitive complaints and symptoms of depression and/or anxiety were randomized to active (n = 12) or sham tDCS (n = 14). The combination of MBSR and tDCS was safe and well tolerated, though at-home adherence and in-class attendance were variable. While they were not statistically significant, the largest effect sizes for active vs. sham tDCS were for everyday mindfulness (d = 0.6) and social functioning (d = 0.9) (F(1,21) = 3.68, p = 0.07 and F(1,21) = 3.9, p = 0.06, respectively).ConclusionsOur findings suggest that it is feasible and safe to combine tDCS with MBSR in older depressed and anxious adults, including during remote, at-home use. Furthermore, tDCS may enhance MBSR via transferring its meditative learning and practice into increases in everyday mindfulness. Future studies need to improve adherence to MBSR with tDCS.Trial RegistrationClinicalTrials.gov (NCT03653351 and NCT03680664).Supplementary InformationThe online version contains supplementary material available at 10.1007/s12671-021-01764-9.