Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection

AbstractThe objective of this randomized controlled trial (RCT) was to assess the impact of rifaximin on the course of liver function, liver regeneration and volumetric recovery in patients undergoing major hepatectomy. The ARROW trial was an investigator initiated, single-center, open-label, phase 3 RCT with two parallel treatment groups, conducted at our hepatobiliary center from 03/2016 to 07/2020. Patients undergoing major hepatectomy were eligible and randomly assigned 1:1 to receive oral rifaximin (550 mg twice daily for 7–10 or 14–21 days in case of portal vein embolization preoperatively and 7 days postoperatively) versus no intervention. Primary endpoint was the relative increase in postoperative liver function measured by LiMAx from postoperative day (POD) 4 to 7. Secondary endpoint were the course of liver function and liver volume during the study period as well as postoperative morbidity and mortality. Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis. The study was prematurely terminated following interim analysis, due to the unlikelihood of reaching a significant primary endpoint. The median relative increase in liver function from POD 4 to POD 7 was 27% in the rifaximin group and 41% in the control group (p = 0.399). Further, no significant difference was found in terms of any other endpoints of functional liver- and volume regeneration or perioperative surgical complications following the application of rifaximin versus no intervention. Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).

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Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

Journal of Evidence-Based Psychotherapies ◽

10.24193/jebp.2020.2.14 ◽

2020 ◽

Vol 20 (2) ◽

pp. 101-120

Author(s):

Ayça Aktaç Gürbüz ◽

Orçun YORULMAZ ◽

Gülşah DURNA

Keyword(s):

Obsessive Compulsive Disorder ◽

Intervention Program ◽

Controlled Trial ◽

Community Sample ◽

Case Vignette ◽

Control Group ◽

Obsessive Compulsive ◽

Compulsive Disorder ◽

Significant Difference ◽

The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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A143 IMPACT OF A SIMULATION-BASED AUGMENTED REALITY CURRICULUM ON POLYPECTOMY SKILLS AMONG NOVICE ENDOSCOPISTS: A RANDOMIZED CONTROLLED TRIAL

Journal of the Canadian Association of Gastroenterology ◽

10.1093/jcag/gwz047.142 ◽

2020 ◽

Vol 3 (Supplement_1) ◽

pp. 5-7

Author(s):

R Khan ◽

M A Scaffidi ◽

N Gimpaya ◽

D Tham ◽

M Atalla ◽

...

Keyword(s):

Augmented Reality ◽

Ad Hoc ◽

Controlled Trial ◽

Skill Training ◽

Control Group ◽

Small Group Teaching ◽

Significant Difference ◽

Simulation Based ◽

Free Environment ◽

The Impact

Abstract Background Polypectomy is an essential endoscopic skill. Training in polypectomy has been identified as a major deficiency for endoscopists worldwide as polypectomy occurs ad hoc during a colonoscopy when a polyp is detected, and a lack of standardized curricula. Augmented reality (AR), which superimposes computer-generated images on a user’s view of the world, can address these gaps by standardizing encounters with polyps while completing simulated procedures and enabling polypectomy-specific teaching. Aims Evaluate the impact of a simulation-based augmented reality curriculum on polypectomy performance among novice endoscopists. Methods This study includes two cohorts of participants from 2019 to 2020. In 2019, participants were randomized into either: (1) a control curriculum, involving 6 hours of simulation-based training (SBT) supplemented by expert feedback, interlaced with 4 hours of small group teaching on the theory of colonoscopy; or (2) the augmented reality curriculum (ARC), in involving the same curriculum with integrated AR, wherein participants engaged with an AR-enhanced video demonstrating relevant therapeutic and pathologic details during polypectomy. The SBT for all participants involved a progressive curriculum starting on a bench-top model and then moving to the EndoVR® virtual reality simulator. The primary outcome was polypectomy-specific performance using the Direct Observation of Polypectomy Skills (DOPyS) tool during a simulated polypectomy after training, with a maximum score of 100. Results Demographic characteristics are summarized in Table. In 2019, 21 novice endoscopists were enrolled. Immediately after training, the mean DOPyS score among ARC group participants was 76.2 (SD=17.9) compared to 71.8 (SD=13.2) among control group participants (Figure). In this interim analysis, there was no significant difference between groups. Data analysis will be completed after 2020 participants complete the study. Conclusions Interim results show a trend towards improved polypectomy performance with no significant difference. The results of this study have the potential to impact polypectomy education among novices. Simulation-based AR interventions may allow learners to progress towards achieving competency in polypectomy in a risk-free environment prior to first patient contact. Funding Agencies None

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A randomised controlled trial to evaluate a medication monitoring system for TB treatment

The International Journal of Tuberculosis and Lung Disease ◽

10.5588/ijtld.21.0373 ◽

2022 ◽

Vol 26 (1) ◽

pp. 44-49

Author(s):

J. Acosta ◽

P. Flores ◽

M. Alarcón ◽

M. Grande-Ortiz ◽

L. Moreno-Exebio ◽

...

Keyword(s):

Controlled Trial ◽

Treatment Success ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Second Phase ◽

Open Label ◽

Pulmonary Tb ◽

Tb Treatment ◽

Significant Difference

BACKGROUND: Adherence to TB treatment and therefore treatment success could be improved using digital adherence technology.OBJECTIVE: To evaluate the effectiveness of a medication event reminder monitor system (MERM) on treatment success and treatment adherence in patients with drug-susceptible pulmonary TB in Perú.METHODS: This was an experimental, randomised, open-label, controlled study conducted among patients in the second phase of TB treatment. The intervention group received their medications through MERM with the support of a treatment monitor, whereas the control group used the usual strategy. Participants were followed until they completed the 54 doses of the second phase of treatment.RESULTS: The study included 53 patients in each group; four in the intervention group withdrew from the study. Treatment success was significantly more frequent in the MERM group (RR 1.15, 95% CI 1.02–1.30; P = 0.0322). There was no significant difference in the adherence outcomes; however, the percentage of patients who missed at least one dose and patients with more than 10% of total doses missed were lower in the intervention group.CONCLUSION: The use of MERM in the second phase of treatment showed a significant improvement in the treatment success rate in patients with drug-susceptible pulmonary TB.

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A Moxifloxacin-based Regimen for the Treatment of Recurrent, Drug-sensitive Pulmonary Tuberculosis: An Open-label, Randomized, Controlled Trial

Clinical Infectious Diseases ◽

10.1093/cid/ciz152 ◽

2019 ◽

Vol 70 (1) ◽

pp. 90-98 ◽

Cited By ~ 1

Author(s):

Rubeshan Perumal ◽

Nesri Padayatchi ◽

Nonhlanhla Yende-Zuma ◽

Anushka Naidoo ◽

Dhineshree Govender ◽

...

Keyword(s):

Adverse Events ◽

Absolute Risk ◽

Controlled Trial ◽

Treatment Success ◽

Control Group ◽

Open Label ◽

Serious Adverse Events ◽

Conversion Rates ◽

Significant Difference ◽

Culture Conversion

Abstract Background The substitution of moxifloxacin for ethambutol produced promising results for improved tuberculosis treatment outcomes. Methods We conducted an open-label, randomized trial to test whether a moxifloxacin-containing treatment regimen was superior to the standard regimen for the treatment of recurrent tuberculosis. The primary and secondary outcomes were the sputum culture conversion rate at the end of 8 weeks and the proportion of participants with a favorable outcome, respectively. Results We enrolled 196 participants; 69.9% were male and 70.4% were co-infected with human immunodeficiency virus (HIV). There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks (83.0% [moxifloxacin] vs 78.5% [control]; P = .463); however, the median time to culture conversion was significantly shorter (6.0 weeks, interquartile range [IQR] 4.0–8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0– 11.4; P = .018). A favorable end-of-treatment outcome was reported in 86 participants (87.8%) in the moxifloxacin group and 93 participants (94.9%) in the control group, for an adjusted absolute risk difference of −5.5 (95% confidence interval −13.8 to 2.8; P = .193) percentage points. There were significantly higher proportions of participants with Grade 3 or 4 adverse events (43.9% [43/98] vs 25.5% [25/98]; P = .01) and serious adverse events (27.6% [27/98] vs 12.2% [12/98]; P = .012) in the moxifloxacin group. Conclusions The replacement of ethambutol with moxifloxacin did not significantly improve either culture conversion rates at the end of 8 weeks or treatment success, and was associated with a higher incidence of adverse events. Clinical Trials Registration NCT02114684.

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Everolimus in patients with advanced pancreatic neuroendocrine tumors (pNET): Updated results of a randomized, double-blind, placebo-controlled, multicenter phase III trial (RADIANT-3).

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.4_suppl.158 ◽

2011 ◽

Vol 29 (4_suppl) ◽

pp. 158-158 ◽

Cited By ~ 3

Author(s):

M. H. Shah ◽

T. Ito ◽

C. Lombard-Bohas ◽

E. M. Wolin ◽

E. Van Cutsem ◽

...

Keyword(s):

Primary Endpoint ◽

Controlled Trial ◽

Somatostatin Analogs ◽

Progression Free Survival ◽

Phase Iii ◽

Open Label ◽

Double Blind ◽

Phase Ii Studies ◽

The Impact ◽

Patient Subgroups

158 Background: There is an unmet medical need for effective treatments for patients with advanced pNET. Systemic therapies for advanced pNET are limited both by toxicity and efficacy. Everolimus, an oral mTOR inhibitor, has shown promising antitumor activity in 2 phase II studies, leading to further investigation in the largest phase III randomized controlled trial completed in pNET patients. Methods: Patients with advanced low- or intermediate-grade pNET were randomly assigned to everolimus 10 mg/d orally + best supportive care (BSC; n = 207) or placebo + BSC (n = 203). Long-acting somatostatin analogs (SSAs) were permitted as BSC during the study. The primary endpoint was progression free survival (PFS). At progression (RECIST), patients could be unblinded and those randomly assigned to placebo were offered open-label everolimus. Results: Compared with placebo, everolimus reduced the risk of progression by 65% and increased median PFS by more than 6 months, from 4.6 to 11.0 months (HR = 0.35; 95% CI: 0.27-0.45; p < 0.0001), by investigator review (primary endpoint). Median PFS by central review was consistent (HR = 0.34; 95% CI: 0.26 to 0.44; p < 0.001] in favor of everolimus. Eighteen-month PFS estimates were 34% for everolimus (95% CI: 26-43) vs 9% (95% CI: 4-16) for placebo. Everolimus demonstrated a significant PFS benefit across all patient subgroups according to baseline characteristics and prior SSA use. Prior SSA use was 49% in the everolimus arm and 50% in the placebo arm. Updated analyses of the impact of concomitant SSA will be reported. The most common drug-related adverse events were stomatitis, rash, diarrhea, fatigue, and infections (primarily upper respiratory); most were grade 1 or 2. Stomatitis (6.9% vs 0%), anemia (6% vs 0%), and hyperglycemia (5% vs 2%) were the most common grade 3-4 events. Conclusions: Everolimus significantly prolonged PFS compared with placebo in patients with advanced pNET in this large phase III clinical trial. This benefit was seen across all patient subgroups. Treatment resulted in a significant 6.4-month prolongation in median PFS. Everolimus had an acceptable and predictable safety profile. [Table: see text]

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Does Nursery-Based Intensified Anticipatory Guidance Reduce Emergency Department Use for Nonurgent Conditions in the First Month of Life? A Randomized Controlled Trial

International Journal of Pediatrics ◽

10.1155/2016/8356582 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6

Author(s):

Kelly Kamimura-Nishimura ◽

Vikram Chaudhary ◽

Folake Olaosebikan ◽

Maryam Azizi ◽

Sneha Galiveeti ◽

...

Keyword(s):

Emergency Department ◽

Controlled Trial ◽

Intervention Group ◽

Newborn Care ◽

Secondary Outcome ◽

Control Group ◽

Anticipatory Guidance ◽

Guidance Program ◽

Significant Difference ◽

The Impact

Objective.We aimed to evaluate the impact of an intensified anticipatory guidance program in the nursery on Emergency Department (ED) use for nonurgent conditions (NUCs) in the neonatal period.Methods. Parturient mothers of healthy newborns were randomized to an intervention group or control group. Baseline and 1-month follow-up knowledge surveys regarding newborn care were conducted. The primary outcome was the proportion of neonates who used the ED for a NUC. Secondary outcome was change in caregivers’ knowledge on NUC.Results. Of a total of 594 mothers, 323 (54%) agreed to participate and were randomized to intervention (n=170) or control (n=153) group. Most were Hispanic (68%), single (61%), primiparous (39%), and without high school diploma (44%). 35 (21%) neonates in the intervention group and 41 (27%) in the control group were brought at least once for a NUC to the ED (p=0.12). There was no statistically significant difference in within subject change on knowledge scores between the two study arms.Conclusions. Neonatal ED visits for NUCs occur frequently. This nursery-based intensified anticipatory guidance program had no statistically significant impact on neonatal ED use for NUC, nor on neonatal care-relevant knowledge among parturient mothers. Alternative modalities and timing of parental educational intervention may need to be considered. This trial is registered with Clinical Trials NumberNCT01859065(Clinicaltrials.gov).

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Advanced Practice Nurse Intervention Versus Usual Care For Hypertension Control: Study Protocol For An Open-Label Randomized Controlled Trial

10.21203/rs.3.rs-38444/v1 ◽

2021 ◽

Author(s):

Juliette Vay-Demouy ◽

Alexandre Vallée ◽

Alexandre Cinaud ◽

Hélène Lelong ◽

Sandrine Kretz ◽

...

Keyword(s):

Usual Care ◽

Healthcare System ◽

Controlled Trial ◽

Medical Doctor ◽

University Hospital ◽

Control Group ◽

Advanced Practice ◽

Open Label ◽

Cardiovascular Assessment ◽

The Impact

Abstract Background: Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises. The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. Methods: The study is designed as prospective, open-label, controlled, randomized 1-to-1 and mono-centric at the Hôtel-Dieu University Hospital, Paris, France. The participants are all hypertensive and recruited during an ambulatory hospitalization (AH) for cardiovascular assessment in the context of the management of their hypertension. Patients are divided into two groups: a control group who keeps a traditional follow-up (AH then consultation with a medical doctor (MD) within approximately two to six months) and an interventional group who will see an APN between the AH and the MD consultation, within 1-3 months. Patients are followed up over six months. The main judgment criterion is BP control (BP < 135/85 mmHg in home BP measurement). The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control. Discussion: This innovative study is a first in France where APNs are at the dawn of their establishment in the healthcare system. It will provide an objective look at this new profession and the impact it can have on the overall management of hypertension. Trial registration: This trial was registered in ClinicalTrials.gov on June 24, 2020: protocol number NCT0448249.

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The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations: Randomized Controlled Trial

JMIR Pediatrics and Parenting ◽

10.2196/18174 ◽

2020 ◽

Vol 3 (2) ◽

pp. e18174

Author(s):

James Brief ◽

Anupama Chawla ◽

Diana Lerner ◽

Bernadette Vitola ◽

Robert Woroniecki ◽

...

Keyword(s):

Arrival Time ◽

Controlled Trial ◽

Smartphone App ◽

Control Group ◽

Phone Calls ◽

Significant Difference ◽

Patient Arrival ◽

Colonoscopy Preparation ◽

The Impact ◽

Pediatric Colonoscopy

Background Smartphone apps have been successfully used to help adults prepare for colonoscopies. However, no study to date has investigated the effect of a smartphone app on pediatric colonoscopy preparation. Objective The aim of this study is to determine if an app (SB Colonoscopy Prep) designed to educate and guide patients through their colonoscopy preparation will yield benefits over paper-based instructions and information. Methods In total, 46 patients aged 5-18 years received either app-based or written material with instructions on how to take their prep medications as well as information about the colonoscopy procedure. Prep quality, the number of calls to the gastroenterology service, and patient arrival time were recorded. After the procedure, a questionnaire was given to each patient through which they graded their knowledge of the procedure both before and after receiving the app or written material. Results App users had higher mean Boston scores versus control subjects receiving written instructions (7.2 vs 5.9, P=.02), indicating better colonoscopy preps. In total, 75% (15/20) of app users and 41% (9/22) of written instruction users had preps categorized as “excellent” on the Boston scale. We found no significant differences in knowledge about the procedure (app users: 10/20 [50%], written instruction users 8/22 [36%]; P=.37), phone calls to the gastroenterology clinic (n=6 vs n=2; P=.27), or arrival times at the endoscopy suite (44 min vs 46 min before the scheduled procedure time; P=.56). Conclusions Smartphone app use was associated with an increased number of colonoscopy preps classified as “excellent” on the Boston scale. There was no significant difference between app users and the control group regarding the number of calls to the gastroenterology clinic, patient arrival time, or patient knowledge about the procedure. Trial Registration ClinicalTrials.gov NCT04590105; https://clinicaltrials.gov/ct2/show/NCT04590105

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AYUSH-64 as an adjunct to Standard Care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India

10.31219/osf.io/xyuas ◽

2021 ◽

Author(s):

Harbans Singh ◽

Sumit Shrivastva ◽

Babita Yadav ◽

Amit Kumar Rai ◽

Sophia Jameela ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Inflammatory Markers ◽

Standard Care ◽

Controlled Trial ◽

Control Group ◽

Rt Pcr ◽

Open Label ◽

Clinical Recovery ◽

Randomized Controlled ◽

Significant Difference

Background: There is limited evidence on the safety and efficacy of administering Ayurveda interventions as add-on to the standard care for COVID-19. Objective: To explore the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in the management of mild to moderate stage COVID-19.Design, setting, participants and interventions: This was an open-label randomized controlled trial with 80 patients of mild to moderate stage COVID-19. Participants in the AYUSH-64 add-on group received two tablets (500 mg each) three times daily for 30 days along with conventional standard care (Paracetamol, Cetirizine, Vitamin C, and Azithromycin). The control group received standard care alone. Main outcome measures: The primary outcome assessed was the proportion of participants with clinical recovery and negative RT-PCR assay for COVID-19 on day 7, 15, 23, and 30. Additionally, change in pro-inflammatory markers, metabolic functions, HRCT chest and incidence of Adverse Drug Reaction (ADR) / Serious Adverse Event (SAE) were assessed.Results: Statistically significant difference was observed in the proportion of participants with clinical recovery in the AYUSH-64 add-on group (p<0.001) at each of the scheduled follow-up visits. All the participants in the AYUSH-64 add-on group clinically recovered by day 23 compared to 32.4 per cent in the control group. The mean duration for clinical recovery in AYUSH-64 add-on group (5.8 ± 2.67 days) was less as compared to control group (10.0 ± 4.06 days). The proportion of participants who turned RT-PCR negative for COVID-19 on day 7, 15, and 23 were 81.8, 94.5, and 100 per cent in AYUSH-64 add-on group, and 79.4, 94.5, and 97.2 per cent in control group, however, the difference observed was statistically not significant (p=0.314). The proportion of participants with improvement in HRCT chest was statistically significant in AYUSH-64 add-on group (p=0.031) unlike in control group (p=0.210). Similar reductions in most inflammatory markers measured (IL-6, CRP, Serum ferritin, and LDH) on day 30 (p<0.05) were observed in both groups. Conclusion: AYUSH-64 as adjunct to standard conventional care is safe and hastens clinical recovery in adult patients with mild to moderate COVID-19.

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