720,901 results match your criteria randomized intervention

Assessment of the Cytoprotective Effects of High-Dose Valproic Acid Compared to a Clinically Used Lower Dose.

J Surg Res 2021 May 11;266:125-141. Epub 2021 May 11.

Department of Surgery, University of Michigan Health System, Ann Arbor, Michigan; Department of Surgery, Feinberg School of Medicine/Northwestern University, Chicago, Illinois. Electronic address:

Objective: Valproic acid (VPA) treatment improves survival in animal models of injuries on doses higher than those allowed by Food and Drug Administration (FDA). We investigated the proteomic alterations induced by a single high-dose (140mg/kg) of VPA (VPA140) compared to the FDA-approved dose of 30mg/kg (VPA30) in healthy humans. We also describe the proteomic and transcriptomic changes induced by VPA140 in an injured patient. Read More

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Multidisciplinary treatment strategy for locally advanced gastric cancer: A systematic review.

Surg Oncol 2021 May 11;38:101599. Epub 2021 May 11.

Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Background: Multidisciplinary management of patients with locally advanced gastric cancer (LAGC) remains unstandardized worldwide. We performed a systemic review to summarize the advancements, regional differences, and current recommended multidisciplinary treatment strategies for LAGC.

Methods: Eligible studies were identified through a comprehensive search of PubMed, Web of Science, Cochrane Library databases and Embase. Read More

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The effect of a mobile application on treatment adherence and symptom management in patients using oral anticancer agents: A randomized controlled trial.

Eur J Oncol Nurs 2021 May 4;52:101969. Epub 2021 May 4.

Department of Nursing, Gazi University, Ankara, Turkey. Electronic address:

Purpose: The use of mobile health technologies in the management of oral anticancer agents (OAA) can be beneficial in terms of treatment adherence and symptom management. This study was conducted to investigate the effect of a mobile application developed for patients using OAA on treatment adherence and symptom management.

Method: The study was conducted using a randomized controlled trial design, and it was carried out on 77 patients. Read More

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Comparison of the cardio-respiratory response of a training session on cycloergometer or treadmill versus an Adapted Physical Activity session on Nintendo Wii, in patients with chronic respiratory disease.

Respir Med Res 2021 Apr 28;79:100827. Epub 2021 Apr 28.

Dept of Internal Medicine and Chest Diseases, EA3878 (GETBO), CIC INSERM 1412, University Hospital of Brest, European University of Occidental Brittany, Brest, France.

Objectives: During a pulmonary rehabilitation program (PRP), patients frequently report that the classically proposed activities (as cycloergometer or treadmill) are not playful. The goal of adapted physical activities is to maintain physical activity that is more playful for patients. The Nintendo Wii Gaming Console allows a playful physical activity. Read More

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Early predictive factors of visual loss at 1-year in neovascular age-related macular degeneration under anti-VEGF in the GEFAL study.

Ophthalmol Retina 2021 May 12. Epub 2021 May 12.

Service d'Ophtalmologie, Hôpital Universitaire de la Croix-Rousse, Hospices Civils de Lyon, Université Lyon 1, Lyon, France; UMR-CNRS 5510 Matéis, Villeurbane, France.

Purpose: To evaluate early predictive factors of visual loss in patients treated with anti-vascular endothelial growth factor (VEGF) injections under as-needed regimen for neovascular age-related macular degeneration (AMD).

Design: Post-hoc analysis from the randomized controlled trial GEFAL, comparing ranibizumab versus bevacizumab for neovascular AMD.

Participants: 393 patients aged ≥50 years with neovascular AMD. Read More

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Spine J 2021 May 12. Epub 2021 May 12.

Instituto de Investigación Biosanitaria Granada (IBIS.Granada), Department of Physical Therapy, University of Granada (UGR), Spain. Electronic address:

Background Context: Chronic low back pain represents a health care problem with substantial costs. It is generally accepted that approximately 10% to 25% of patients with persistent chronic low back pain may have pain arising from the sacroiliac joints.

Purpose: This study aimed to analyze the effects of manipulative therapy of sacral torsion versus myofascial release on disability, pain intensity, and mobility in patients with chronic low back pain and sacroiliac joints. Read More

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Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial.

Contemp Clin Trials 2021 May 12:106433. Epub 2021 May 12.

School of Nursing, Indiana University, Bloomington, IN, United States of America.

This randomized controlled trial aims to determine the feasibility and preliminary efficacy of a patient-centered, mobile health technology intervention (iCardia4HF) in patients with chronic HF. Participants (n = 92) are recruited and randomized 1:1 to the intervention or control group. The intervention group receives a commercial HF self-care app (Heart Failure Storylines), three connected health devices that interface with the app (Withings weight scale and blood pressure monitor, and Fitbit activity tracker), and a program of individually tailored text-messages targeting health beliefs, self-care self-efficacy, HF-knowledge, and physical activity. Read More

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Effect of local anesthetics on postoperative pain in patients undergoing gynecological laparoscopy: A systematic review and meta-analysis of randomized trials.

J Minim Invasive Gynecol 2021 May 12. Epub 2021 May 12.

King's Fertility, Fetal Medicine Research Institute, London, United Kingdom.

Objective: Pain remains a common complication following gynecological laparoscopy. Use of local anesthesia may be beneficial in reducing postoperative pain. We performed a systematic review and meta-analysis to assess whether local anesthetic decreases postoperative pain following laparoscopic gynecological procedures. Read More

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Comparison of the intubation success rate between the intubating catheter and videolaryngoscope in difficult airways: a prospective randomized trial.

Braz J Anesthesiol 2021 May 12. Epub 2021 May 12.

Selcuk University Medical Faculty, Department of Anesthesiology and Intensive Care, Konya, Turkey.

Background: Several devices and algorithms have already been examined and compared for difficult airway management. However, there is no existing study comparing the success of the Intubating Catheter (IC) and the Videolaryngoscope (VL) in patients who are difficult to intubate. We aimed to compare Frova IC and McGrath VL in terms of intubation success rates in patients with difficult intubation. Read More

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Behavioral therapy is superior to follow-up without intervention in patients with supragastric belching-A randomized study.

Neurogastroenterol Motil 2021 May 15:e14171. Epub 2021 May 15.

Department of Gastroenterology, Helsinki University Hospital, Helsinki, Finland.

Background: Behavioral therapy (BT) has been proven effective in the treatment of supragastric belching (SGB) in open studies. The aim was to compare BT to follow-up without intervention in patients with SGB in a randomized study.

Methods: Forty-two patients were randomized to receive 5 sessions of BT, comprising diaphragmatic breathing exercises, or to follow-up without intervention. Read More

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Sex Differences Among Patients With High Risk Receiving Ticagrelor With or Without Aspirin After Percutaneous Coronary Intervention: A Subgroup Analysis of the TWILIGHT Randomized Clinical Trial.

JAMA Cardiol 2021 May 15. Epub 2021 May 15.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

Importance: Shortened dual antiplatelet therapy followed by potent P2Y12 receptor inhibitor monotherapy reduces bleeding without increasing ischemic events after percutaneous coronary intervention (PCI).

Objective: To explore sex differences and evaluate the association of sex with outcomes among patients treated with ticagrelor monotherapy vs ticagrelor plus aspirin.

Design, Setting, And Participants: This was a prespecified secondary analysis of TWILIGHT, an investigator-initiated, placebo-controlled randomized clinical trial conducted at 187 sites across 11 countries. Read More

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Efficacy of ultra-low volume (≤1L) bowel preparation fluids - systematic review and meta-analysis.

Dig Endosc 2021 May 15. Epub 2021 May 15.

Radboud university medical center, Radboud Institute for Health Sciences, Department of Gastroenterology and Hepatology, Nijmegen, The Netherlands.

Background And Aims: High-quality bowel preparation is paramount for the diagnostic accuracy and safety of colonoscopy; however, it is often difficult for patients to adhere to high-volume laxatives, which may contribute to poor bowel preparation. This review aims to assess the efficacy of bowel preparation fluids of 1L or less (≤1L).

Methods: We performed a systematic review including all relevant randomized controlled trials on ultra-low volume (≤1L) bowel preparation fluids for colonoscopy published since 2015. Read More

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Strength training in addition to neuromuscular exercise and education in individuals with knee osteoarthritis the effects on pain and sensitization.

Eur J Pain 2021 May 15. Epub 2021 May 15.

The Research Unit PROgrez, Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospitals, Region Zealand, Slagelse, Denmark.

Background: There is a lack of evidence of the relative effects of different exercise modes on pain sensitization and pain intensity in individuals with knee osteoarthritis (KOA).

Methods: Ninety individuals with radiographic and symptomatic KOA, ineligible for knee replacement surgery, were randomized to 12 weeks of twice-weekly strength training in addition to neuromuscular exercise and education (ST+NEMEX-EDU) or neuromuscular exercise and education alone (NEMEX-EDU). Outcomes were bilateral, lower-leg, cuff pressure pain- and tolerance thresholds (PPT, PTT), temporal summation (TS), conditioned pain modulation (CPM), self-reported knee pain intensity, and number of painful body sites. Read More

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Direct Comparison of Risankizumab and Fumaric Acid Esters in Systemic-Therapy-Naive Patients With Moderate to Severe Plaque Psoriasis: A Randomized Controlled Trial.

Br J Dermatol 2021 May 15. Epub 2021 May 15.

Dermatologikum, Hamburg, Germany.

Background: Fumaric acid esters (FAEs; Fumaderm ) are the most frequently prescribed first-line systemic treatment for moderate-to-severe plaque psoriasis in Germany. Risankizumab (Skyrizi ) is a humanized IgG1 monoclonal antibody that specifically binds to the p19 subunit of interleukin-23.

Objective: This study compared risankizumab treatment with FAEs in psoriasis patients. Read More

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Atrial natriuretic peptide does not degrade the endothelial glycocalyx: a secondary analysis of a randomized porcine model.

Acta Anaesthesiol Scand 2021 May 15. Epub 2021 May 15.

Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Section of Cardiothoracic Anaesthesia and Intensive Care, Gothenburg, Sweden.

Background: The atrial natriuretic peptide released from the heart regulates intravascular volume and is suspected to increase capillary permeability. Contradictory results regarding ANP and glycocalyx degradation have been reported. The aim of this study was to investigate if an infusion of ANP causes degradation of the endothelial glycocalyx. Read More

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Cognitive behavioral therapy cannot relieve postoperative pain and improve joint function after total knee arthroplasty in patients aged 70 years and older.

Aging Clin Exp Res 2021 May 15. Epub 2021 May 15.

Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, 99 Huaihai Road, Xuzhou, 221002, Jiangsu, China.

Purpose: A randomized controlled trial was conducted to investigate whether cognitive behavioral therapy (CBT) can improve postoperative pain, knee function, and negative emotion in patients aged 70 years and older who underwent total knee arthroplasty (TKA).

Methods: This study used randomized, parallel group, controlled trial to divide the included 90 patients into CBT group and usual care group. The primary outcome measure of the study was the Visual Analogue Scale (VAS) at activity. Read More

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Pharmacokinetics and Comparative Bioavailability of Apomorphine Sublingual Film and Subcutaneous Apomorphine Formulations in Patients with Parkinson's Disease and "OFF" Episodes: Results of a Randomized, Three-Way Crossover, Open-Label Study.

Neurol Ther 2021 May 15. Epub 2021 May 15.

Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.

Introduction: In a pivotal study, apomorphine sublingual film (APL; KYNMOBI) was an effective and generally well-tolerated on-demand treatment of "OFF" episodes in patients with Parkinson's disease (PD), approved across the dose range of 10-30 mg. Pharmacokinetics and comparative bioavailability of APL and two subcutaneous (SC) apomorphine formulations (SC-APO [APOKYN] and SC-APO-GO [APO-go PEN]) were evaluated in a randomized, three-way crossover, open-label study (NCT03292016).

Methods: Patients with PD and "OFF" episodes received an open-label randomized sequence of single doses of SC-APO and SC-APO-GO at the currently prescribed dose (2/3/4/5 mg) and APL doses with similar plasma exposure (15/20/25/30 mg) with ≥ 1-day washout between formulations. Read More

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Evaluating the efficacy of nitazoxanide in uncomplicated amebic liver abscess.

Indian J Gastroenterol 2021 May 15. Epub 2021 May 15.

Department of Gastroenterology, SMS Medical College and Hospital, Jaipur 302 004, India.

Background: Amebic liver abscess is treated successfully with metronidazole or another nitroimidazole drug followed by a luminal amebicide. Metronidazole has long been preferred, but has been associated with several adverse effects including intolerance in certain clinical situations. Mechanisms of metronidazole resistance and mutagenic potential have been described. Read More

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Current state of machine learning for non-melanoma skin cancer.

Arch Dermatol Res 2021 May 15. Epub 2021 May 15.

Department of Dermatology, University of California, Irvine, 1 Medical Plaza Drive, Irvine, CA, 92617, USA.

Background: Machine learning (ML) has been increasingly utilized for skin cancer screening, primarily of melanomas but also of non-melanoma skin cancers (NMSC).

Objective: This study presents the first quantitative review of the success of these techniques in NMSC screening.

Methods: A primary literature search was conducted using PubMed, MEDLINE, and arXiv, capturing all articles involving ML techniques and NMSC screening. Read More

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Effect of vaginal estrogen in postmenopausal women using vaginal pessary for pelvic organ prolapse treatment: a randomized controlled trial.

Int Urogynecol J 2021 May 15. Epub 2021 May 15.

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Introduction And Hypothesis: Evidence and recommendations for the use of intravaginal estrogen for prevention of bacterial vaginosis and pessary-related complications are limited and controversial. We hypothesized that adding intravaginal estrogen to pessary use would decrease the incidence of bacterial vaginosis and other pessary-related complications.

Methods: A single-center, open-label, randomized, parallel study was conducted between April 2018 and August 2020. Read More

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Efficacy and safety of the EMS Swiss LithoClast® Trilogy for PCNL: results of the European multicentre prospective study on behalf of European Section of UroTechnology.

World J Urol 2021 May 15. Epub 2021 May 15.

Department of Urology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Hills Road, Cambridge, CB2 0QQ, UK.

Purpose: PCNL requires a lithotrite to efficiently break stones, and some devices include active suction to remove the fragments. We set out to determine the efficacy and safety of the Swiss LithoClast® Trilogy, in a prospective European multicentre evaluation and compared it to published stone clearance rates for Trilogy based on surface area (68.9 mm/min) and using the 3D calculated stone volume (526. Read More

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Topical corticosteroids for phimosis in children: a network meta-analysis of randomized clinical trials.

Pediatr Surg Int 2021 May 15. Epub 2021 May 15.

Department of Dental Training, Ministry of Health, Manama, Kingdom of Bahrain.

Background: Corticosteroids and hyaluronidase are trialed for treating phimosis in children. We carried out the present network meta-analysis to compare the therapeutic effect of these drugs.

Methods: Electronic databases were searched for appropriate randomized clinical trials. Read More

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Effect of orlistat on live birth rate in overweight or obese women undergoing IVF-ET: A randomized clinical trial.

J Clin Endocrinol Metab 2021 May 15. Epub 2021 May 15.

Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University; The Key Laboratory of Reproductive Endocrinology of Ministry of Education; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, China.

Context: Obesity management prior to infertility treatment remains a challenge. To date, results from randomized clinical trials involving weight loss by lifestyle interventions have shown no evidence of improved live birth rate.

Objective: To determine whether pharmacologic weight-loss intervention before in vitro fertilization and embryo transfer (IVF-ET) can improve live birth rate among overweight or obese women. Read More

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Eligibility of outpatients with chronic heart failure for sodium-glucose co-transporter-2 inhibitors.

ESC Heart Fail 2021 May 15. Epub 2021 May 15.

Department of Medical and Surgical Science, University of Foggia, Viale Luigi Pinto 1, Foggia, 71122, Italy.

Aims: Sodium-glucose co-transporter-2 inhibitors (SGLT2i) have been shown to have a relevant role in the prevention of hospitalizations for heart failure and improvement in the life expectancy of patients with diabetes and outpatients with chronic heart failure (CHF) with reduced left ventricular ejection fraction, independently from the presence of type 2 diabetes mellitus (T2DM). The aim of our study was to evaluate in a real-world population the number of outpatients with CHF who meet the enrolment criteria of the main randomized controlled trials (RCT) published in the last 5 years and consequently identify the percentage of patients who could potential benefit from SGLT2i therapy.

Methods And Results: We retrospectively evaluated all consecutive outpatients referred for CHF. Read More

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Fatigue Perpetuating Factors as Mediators of Change in a Cognitive Behavioral Intervention for Targeted Therapy-Related Fatigue in Chronic Myeloid Leukemia: A Pilot Study.

Ann Behav Med 2021 May 15. Epub 2021 May 15.

Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA.

Background: Cognitive behavioral therapy for targeted-therapy related fatigue (CBT-TTF) has demonstrated preliminary efficacy in reducing fatigue in patients treated with tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia (CML).

Purpose: The aim of the current analyses was to explore whether fatigue perpetuating factors (disturbed sleep/wake cycle, dysregulated activity patterns, maladaptive cognitions about fatigue and cancer, insufficient processing of cancer and treatment, inadequate social support and interactions, heightened fear of cancer progression) changed over time in patients receiving CBT-TTF, and whether the effect of CBT-TTF on fatigue was mediated by these factors.

Methods: Secondary data analyses were conducted from a pilot randomized controlled trial. Read More

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Centrally acting anticholinergic drug trihexyphenidyl is highly effective in reducing nightmares associated with post-traumatic stress disorder.

Brain Behav 2021 May 14:e02147. Epub 2021 May 14.

Sogo PTSD Institute, Medical Corporation Sogokai, Hiroshima-city, Japan.

Introduction: Following a case study on scopolamine butyl bromide, an anticholinergic drug, we studied the effect of a central anticholinergic drug on post-traumatic stress disorder (PTSD)-related flashbacks and nightmares.

Methods: We administered trihexyphenidyl (TP) to 34 patients with refractory PTSD-related nightmares and flashbacks (open-label trial [n = 22]; single-blind trial [n = 12]), who had previously received psychiatric treatment for approximately 2-15 years, without therapeutic benefits. The effect of TP was determined using the Clinician-Administered PTSD Scale (CAPS) and the Impact of Event Scale-Revised (IES-R). Read More

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Feasibility, efficacy, and safety of ethanol infusion into the vein of Marshall for atrial fibrillation: a meta-analysis.

Pacing Clin Electrophysiol 2021 May 14. Epub 2021 May 14.

Heart Center, the First Hospital of Lanzhou University, Lanzhou, China.

Background: Contemporary radiofrequency catheter ablation (RFCA) approaches for atrial fibrillation (AF) have reached an efficacy "ceiling". Ethanol infusion into the vein of Marshall (EI-VOM) has shown potential in preliminary studies. Data on EI-VOM are largely limited to small single-center reports, and clinical benefits and risks have not been systematically examined. Read More

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Safety, pharmacokinetics and pharmacodynamics of TAK-418, a novel inhibitor of the epigenetic modulator lysine-specific demethylase 1A.

Br J Clin Pharmacol 2021 May 14. Epub 2021 May 14.

Takeda Pharmaceuticals U.S.A., Inc., Cambridge, MA, USA.

Aim: Dysregulation of histone methylation epigenetic marks may result in intellectual and developmental disability, as seen in Kabuki syndrome. Animal data suggest that increasing histone methylation by inhibiting lysine-specific demethylase 1A (LSD1) may improve cognitive outcomes in a model of Kabuki syndrome. TAK-418 is a novel LSD1 inhibitor, developed as a potential therapeutic agent for central nervous system disorders such as Kabuki syndrome. Read More

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Phase 2 randomized placebo-controlled study of lasmiditan for the acute treatment of migraine in Japanese patients.

Headache 2021 May 15. Epub 2021 May 15.

Eli Lilly Japan K.K., Kobe, Japan.

Objective: To evaluate the efficacy and safety of lasmiditan in Japanese adults with migraine.

Background: Global clinical studies have demonstrated the efficacy and safety of lasmiditan in the acute treatment of migraine.

Methods: This was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study in Japan (NCT03962738), which enrolled adults with migraine with or without aura. Read More

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Well-being warriors: A randomized controlled trial examining the effects of martial arts training on secondary students' resilience.

Br J Educ Psychol 2021 May 15:e12422. Epub 2021 May 15.

Macquarie University, NSW, Australia.

Background: Mental health problems are a growing and significant issue in the Australian education system. Research has suggested that resilience can be learned and that schools can play an important role in developing resilient skills among youth; however, rigorous evaluation of interventions promoting resilience is limited.

Aims: As martial arts training has been found to have psychological benefits such as increased confidence and self-esteem, this study investigated whether a 10-week martial arts training programme was an efficacious sports-based mental health intervention that promoted resilience in secondary school students. Read More

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