850,386 results match your criteria controlled trial


Neurocognitive Empowerment for Addiction Treatment (NEAT): study protocol for a randomized controlled trial.

Trials 2021 May 7;22(1):330. Epub 2021 May 7.

Laureate Institute for Brain Research, 6655 South Yale Ave., Tulsa, OK, 74136, USA.

Background: Neurocognitive deficits (NCDs) and associated meta-cognition difficulties associated with chronic substance use often delay the learning and change process necessary for addiction recovery and relapse prevention. However, very few cognitive remediation programs have been developed to target NCDs and meta-cognition for substance users. The study described herein aims to investigate the efficacy of a multi-component neurocognitive rehabilitation and awareness program termed "Neurocognitive Empowerment for Addiction Treatment" (NEAT). Read More

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Using historical data to facilitate clinical prevention trials in Alzheimer disease? An analysis of longitudinal MCI (mild cognitive impairment) data sets.

Alzheimers Res Ther 2021 May 7;13(1):97. Epub 2021 May 7.

University Department of Geriatric Medicine FELIX PLATTER, Basel, Switzerland.

Background: The Placebo Group Simulation Approach (PGSA) aims at partially replacing randomized placebo-controlled trials (RPCTs), making use of data from historical control groups in order to decrease the needed number of study participants exposed to lengthy placebo treatment. PGSA algorithms to create virtual control groups were originally derived from mild cognitive impairment (MCI) data of the Alzheimer's Disease Neuroimaging Initiative (ADNI) database. To produce more generalizable algorithms, we aimed to compile five different MCI databases in a heuristic manner to create a "standard control algorithm" for use in future clinical trials. Read More

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Active elderly and health-can moderate exercise improve health and wellbeing in older adults? Protocol for a randomized controlled trial.

Trials 2021 May 7;22(1):331. Epub 2021 May 7.

Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Background: Aging is marked by a progressive rise in chronic diseases with an impact on social and healthcare costs. Physical activity (PA) may soothe the inconveniences related to chronic diseases, has positive effects on the quality of life and biological rhythms, and can prevent the decline in motor functions and the consequent falls, which are associated with early death and disability in older adults.

Methods: We randomized 120 over-65 males and females into groups of similar size and timing and will give each either moderate physical activity or cultural and recreational activities. Read More

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Monitoring of patients with microdialysis following pancreaticoduodenectomy-the MINIMUM study: study protocol for a randomized controlled trial.

Trials 2021 May 7;22(1):329. Epub 2021 May 7.

Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Rikshospitalet, Postboks 4950 Nydalen, 0424, Oslo, Norway.

Background: Postoperative pancreatic fistula after pancreatoduodenectomy is a much-feared complication associated with substantial mortality and morbidity. The current standard for diagnosing postoperative pancreatic fistula, besides routine clinical examination, include radiological examinations, analysis of pancreatic drain amylase activity, and routine blood samples. Another promising method is by intraperitoneal microdialysis to monitor intraperitoneal metabolites measured at the pancreaticojejunostomy, thereby detecting what occurs locally, before chemical events can be reflected as measurable changes in systemic blood levels. Read More

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Protocol for a family-centered behavioral intervention to reduce early childhood caries: the MySmileBuddy program efficacy trial.

BMC Oral Health 2021 May 7;21(1):246. Epub 2021 May 7.

Mailman School of Public Health, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit 47, New York, NY, 10032, USA.

Background: Although largely preventable through diet management and topical fluoride use, early childhood caries (ECC) often progresses to severity that necessitates surgical repair. Yet repair often fails to mitigate caries progression. Needed is an effective behavioral intervention to address underlying behavioral causes. Read More

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Multiple intravenous tranexamic acid doses in total knee arthroplasty in patients with rheumatoid arthritis: a randomized controlled study.

BMC Musculoskelet Disord 2021 May 7;22(1):425. Epub 2021 May 7.

Shanghai University of Traditional Chinese Medicine, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, 200052, CN, China.

Background: We aimed to determine the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who had undergone primary unilateral total knee arthroplasty (TKA).

Methods: For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants with RA, aged 50-75 years, who underwent unilateral primary TKA were recruited. The patients received one dose of 1 g IV-TXA 10 min before skin incision, followed by articular injection of 1. Read More

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Checkpoint inhibition in combination with an immunoboost of external beam radiotherapy in solid tumors (CHEERS): study protocol for a phase 2, open-label, randomized controlled trial.

BMC Cancer 2021 May 7;21(1):514. Epub 2021 May 7.

Cancer Research Institute Ghent (CRIG), Ghent University, Ghent, Belgium.

Background: While the introduction of checkpoint inhibitors (CPIs) as standard of care treatment for various tumor types has led to considerable improvements in clinical outcome, the majority of patients still fail to respond. Preclinical data suggest that stereotactic body radiotherapy (SBRT) could work synergistically with CPIs by acting as an in situ cancer vaccine, thus potentially increasing response rates and prolonging disease control. Though SBRT administered concurrently with CPIs has been shown to be safe, evidence of its efficacy from large randomized trials is still lacking. Read More

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The effect of dexmedetomidine on intraoperative blood glucose homeostasis: secondary analysis of a randomized controlled trial.

BMC Anesthesiol 2021 May 7;21(1):139. Epub 2021 May 7.

Department of Anesthesiology, Peking University First Hospital, Beijing, China.

Purpose: To investigate the effect of dexmedetomidine on intraoperative blood glucose hemostasis in elderly patients undergoing non-cardiac major surgery.

Methods: This was secondary analysis of a randomized controlled trial. Patients in dexmedetomidine group received a loading dose dexmedetomidine (0. Read More

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Long-Term Effects on Loneliness of a Computer-Tailored Intervention for Older Adults With Chronic Diseases: A Randomized Controlled Trial.

J Aging Health 2021 May 7:8982643211015027. Epub 2021 May 7.

Faculty of Psychology, 10198Open University of The Netherlands, Heerlen, The Netherlands.

This study explores the effects of the Active Plus intervention aiming to decrease loneliness among older adults (>65 years) with chronic diseases. A randomized controlled trial (RCT) was performed = 585; age: = 74.5 years, = 6. Read More

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Education With Therapeutic Alliance Did Not Influence the Improvement of Symptoms of Patients With Chronic Low Back Pain and Low Risk of Poor Prognosis Compared to Education Without Therapeutic Alliance: A Randomized Controlled Trial.

J Orthop Sports Phys Ther 2021 May 7:1-26. Epub 2021 May 7.

Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, SP, Brazil.

Objectives: To assess the effectiveness of an educational intervention with or without the addition of the therapeutic alliance in patients with nonspecific chronic low back pain (LBP) and low risk of poor prognosis.

Design: Randomized controlled trial. Randomization was performed using random generated numbers. Read More

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Herbal supplement (Combi-5) in the management of COVID 19 individual with mild to moderate symptoms: a case report.

J Complement Integr Med 2021 May 7. Epub 2021 May 7.

Plateau State Specialist Hospital, Jos, Plateau State, Nigeria.

Objective: To explore repurposing known natural products for managing patients with mild to moderate symptoms of COVID-19.

Case Presentation: We present a case report of a middle aged woman, who was positive to COVID 19, with mild to moderate symptoms; who self -managed at home using well formulated herbal supplement (Combi-5) taken along with vitamin C and Zinc supplements. She recovered within a short time. Read More

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Exercise-based cardiac rehabilitation for adults after heart valve surgery.

Cochrane Database Syst Rev 2021 May 7;5:CD010876. Epub 2021 May 7.

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital, Nyborg, Denmark.

Background: The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery.

Objectives: To assess the benefits and harms of exercise-based CR compared with no exercise training in adults following heart valve surgery or repair, including both percutaneous and surgical procedures. Read More

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Time-of-day effects of consumption of fish oil-enriched sausages on serum lipid parameters and fatty acid composition in normolipidemic adults: A randomized, double-blind, placebo-controlled, and parallel-group pilot study.

Nutrition 2021 Mar 24;90:111247. Epub 2021 Mar 24.

Healthy Food Science Research Group, Cellular and Molecular Biotechnology Research Institute, National Institute of Advanced Industrial Science and Technology, Tsukuba, Ibaraki, Japan; Department of Applied Biological Science, Graduate School of Science and Technology, Tokyo University of Science, Noda, Chiba, Japan; Department of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa, Chiba, Japan; School of Integrative and Global Majors, University of Tsukuba, Tsukuba, Ibaraki, Japan. Electronic address:

Objectives: The body clock controls diurnal rhythms of nutrient digestion, absorption, and metabolism. Fish oil (FO) contains abundant ω-3 polyunsaturated fatty acids (PUFA), including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), that are thought to lower triglyceride (TG) levels. This randomized, placebo-controlled, double-blind, parallel-group trial aimed to confirm the effects of the time of FO intake on TG in healthy Japanese adults. Read More

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The analgesic efficacy of forearm vfversus upper arm intravenous regional anesthesia (Bier's block): A randomized controlled non-inferiority trial.

J Clin Anesth 2021 May 5;73:110329. Epub 2021 May 5.

Department of Anaesthesiology and Pain Medicine, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, Diepenbeek, Belgium.

Study Objective: This study aimed to assess if a forearm (FA) intravenous regional anesthesia (IVRA) with a lower, less toxic, local anesthetic dosage is non-inferior to an upper arm (UA) IVRA in providing a surgical block in patients undergoing hand and wrist surgery.

Design: Observer-blinded, randomized non-inferiority study.

Setting: Operating room. Read More

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Does theme game-based teaching promote better learning about disaster nursing than scenario simulation: A randomized controlled trial.

Nurse Educ Today 2021 Apr 24;103:104923. Epub 2021 Apr 24.

Wuhan University, School of Health Sciences Faculty of Nursing, No. 115 Donghu Road, Wuchang, Wuhan, Hubei Province 430071, PR China. Electronic address:

Background: With the development of information technology, game-based teaching has continuously attracted the attention of nursing educators. It has been proven that games, as an auxiliary tool of traditional teaching, can improve students' learning motivation and learning effects. However, compared with the traditional scenario simulation teaching, whether game-based teaching has obvious advantages is still unknown. Read More

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Effect of the TEACCH program on the rehabilitation of preschool children with autistic spectrum disorder: A randomized controlled trial.

J Psychiatr Res 2021 Apr 30;138:420-427. Epub 2021 Apr 30.

School of Health Sciences, Wuhan University, Wuhan, China; Department of Psychiatry, Renmin Hospital of Wuhan University, Wuhan, China; Population and Health Research Center, Wuhan University, Wuhan, China. Electronic address:

Objectives: This study aimed to explore the effect of Treatment and Education of Autistic and Communication Handicapped Children (TEACCH) intervention on the rehabilitation of preschool children having autism spectrum disorder (ASD) in China.

Methods: Sixty children with ASD were randomly assigned to the intervention group (n = 30) or the control group (n = 30). The intervention group received TEACCH training plus Discrete Trial Teaching (DTT) for six months, while the control group received only DTT. Read More

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The efficacy and acceptability of hybrid electroconvulsive therapy compared with standard electroconvulsive therapy for schizophrenia patients: A parallel-group, double-blind, randomized, controlled trial.

Brain Stimul 2021 May 4. Epub 2021 May 4.

Department of Psychiatry, Shenzhen Kangning Hospital, and Shenzhen Mental Health Center, Shenzhen, Guangdong, China; Brain Function and Psychosomatic Medicine Institute, Second People's Hospital of Huizhou, Huizhou, Guangdong, China. Electronic address:

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Feasibility of reducing frailty components in older adults with Alzheimer's dementia: a randomized controlled home-based exercise trial (AD-HOMEX).

Exp Gerontol 2021 May 5;150:111390. Epub 2021 May 5.

Department of Physical Therapy, Federal University of São Carlos, São Carlos, Brazil.

Objectives: There is a need for interventions to reduce frailty in older people with Alzheimer's dementia (AD). The purpose of this study was to investigate the effect of a home-based multimodal exercise program for older adults with AD (AD-HOMEX) on frailty.

Design: A parallel single-blind randomized controlled trial comparing a home-based exercise program and usual care. Read More

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Hydroxychloroquine reduces interleukin-6 levels after myocardial infarction: The randomized, double-blind, placebo-controlled OXI pilot trial.

Int J Cardiol 2021 May 4. Epub 2021 May 4.

Heart and Lung Center, Helsinki University Hospital, Helsinki University, Helsinki, Finland. Electronic address:

Objectives: To determine the anti-inflammatory effect and safety of hydroxychloroquine after acute myocardial infarction.

Method: In this multicenter, double-blind, placebo-controlled OXI trial, 125 myocardial infarction patients were randomized at a median of 43 h after hospitalization to receive hydroxychloroquine 300 mg (n = 64) or placebo (n = 61) once daily for 6 months and, followed for an average of 32 months. Laboratory values were measured at baseline, 1, 6, and 12 months. Read More

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Results of the first pilot randomized controlled trial of fecal microbiota transplant in pediatric ulcerative colitis: lessons, limitations, and future prospects.

Gastroenterology 2021 May 4. Epub 2021 May 4.

Farncombe Family Digestive Health Research Institute, McMaster University; Department of Medicine, Division of Gastroenterology, McMaster University; 1280 Main Street West, Hamilton, Ontario, Canada, L8S 4L8.

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Topical emollient for preventing infection in preterm infants.

Cochrane Database Syst Rev 2021 May 7;5:CD001150. Epub 2021 May 7.

Centre for Reviews and Dissemination, University of York, York, UK.

Background: Breakdown of the developmentally immature epidermal barrier may permit entry for micro-organisms leading to invasive infection in preterm infants. Topical emollients may improve skin integrity and barrier function and thereby prevent invasive infection, a major cause of mortality and morbidity in preterm infants.

Objectives: To assess the effect of topical application of emollients (ointments, creams, or oils) on the risk of invasive infection and mortality in preterm infants. Read More

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Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors.

PLoS One 2021 7;16(5):e0251276. Epub 2021 May 7.

Leibniz Research Centre (IfADo), Technical University of Dortmund, Dortmund, Germany.

Introduction: After the acute treatment phase, breast cancer patients often experience low quality of life and impaired mental health, which could potentially be improved by offering cognitive behavioural therapy (CBT) and addressing exercise and dietary habits. However, CBT and other behavioural interventions are rarely available beyond the acute treatment phase. Internet-based interventions could bridge such treatment gaps, given their flexibility and scalability. Read More

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Red light emitting diode as an adjuvant treatment for epidermal growth factor receptor inhibitors-induced paronychia.

J Dermatolog Treat 2021 May 7:1-16. Epub 2021 May 7.

Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.

We evaluated the efficacy and safety of red light LED as an adjuvant treatment for epidermal growth factor receptor inhibitor-induced paronychia. Eight patients were recruited in this randomized, single-blinded controlled trial. They were randomized to receive red-light on one hand or foot 2-3 times/week for 6 weeks while the contralateral side served as controls. Read More

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Supervised exercises versus telerehabilitation. Benefits for persons with multiple sclerosis.

Acta Neurol Scand 2021 May 7. Epub 2021 May 7.

Department of Ergotherapy, School of Health Sciences, Istanbul Medipol University, Istanbul, Turkey.

Objectives: The purpose of this study was to investigate the effectiveness of structured telerehabilitation on fatigue, health status, quality of life (QoL), and activities of daily living (ADL) and compare the possible effects with structured supervised exercise programs in patients with Multiple Sclerosis.

Materials And Methods: This study was a randomized, single-blind trial. Thirty patients with relapsing-remitting Multiple Sclerosis were included in the study and randomly divided into two groups; structured supervised exercise group (Group 1) and telerehabilitation group (Group 2). Read More

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A randomised evaluation of low-dose cytosine arabinoside (ara-C) plus tosedostat versus low-dose ara-C in older patients with acute myeloid leukaemia: results of the LI-1 trial.

Br J Haematol 2021 May 7. Epub 2021 May 7.

Department of Haematology, Nottingham University Hospitals, Nottingham, UK.

Older patients with acute myeloid leukaemia (AML) account for nearly half of those with the disease. Because they are perceived to be unfit for, unwilling to receive, or unlikely to benefit from conventional chemotherapy they represent an important unmet need. Tosedostat is a selective oral aminopeptidase inhibitor, which in phase I/II trials showed acceptable toxicity and encouraging efficacy. Read More

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Just-in-Time Teaching (JiTT) Screencasts: a Randomized Controlled Trial of Asynchronous Learning on an Inpatient Hematology-Oncology Teaching Service.

J Cancer Educ 2021 May 7. Epub 2021 May 7.

Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Background: The efficacy of just-in-time teaching (JiTT) screencasts for graduate medical education on an inpatient adult hematology-oncology service (HOS) setting is not known. Our preceding pilot data identified six high-yield topics for this setting. The study objective was to evaluate screencast educational efficacy. Read More

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Improving Caregiver Self-Efficacy and Children's Behavioral Outcomes via a Brief Strength-Based Video Coaching Intervention: Results from a Randomized Controlled Trial.

Prev Sci 2021 May 7. Epub 2021 May 7.

Department of Psychology and Center for Translational Neuroscience, University of Oregon, Eugene, OR, USA.

Many existing preventive intervention programs focus on promoting responsive parenting practices. However, these parenting programs are often long in duration and expensive, and meta-analytic evidence indicates that families facing high levels of adversity typically benefit less. Moreover, due to a lack of specification and evaluation of conceptual models, the mechanisms underlying program-related changes in caregivers and their children often remain unclear. Read More

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Update on Treatment of Hypertension After Renal Transplantation.

Curr Hypertens Rep 2021 May 7;23(5):25. Epub 2021 May 7.

Department of Internal Medicine 4-Nephrology, University Hospital of Erlangen, Erlangen, Germany.

Purpose Of Review: To incorporate novel findings on pathophysiology and treatment of posttransplant hypertension.

Recent Findings: (1) The sodium retaining effects of CNIs are mediated by stimulation of the thiazide-sensitive sodium chloride co-transporter in the distal convoluted tubule and in this regard chlorthalidone was proven to be an effective antihypertensive drug in renal transplantation. (2) Local and not systemic activation of the renin-angiotensin-aldosterone system plays a crucial role in the pathogenesis of posttransplant hypertension. Read More

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Restrictive fluid management versus usual care in acute kidney injury (REVERSE-AKI): a pilot randomized controlled feasibility trial.

Intensive Care Med 2021 May 7. Epub 2021 May 7.

Department of Intensive Care, Austin Hospital, Melbourne, Australia.

Purpose: We compared a restrictive fluid management strategy to usual care among critically ill patients with acute kidney injury (AKI) who had received initial fluid resuscitation.

Methods: This multicenter feasibility trial randomized 100 AKI patients 1:1 in seven ICUs in Europe and Australia. Restrictive fluid management included targeting negative or neutral daily fluid balance by minimizing fluid input and/or enhancing urine output with diuretics administered at the discretion of the clinician. Read More

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In patients with multi-vessel coronary artery diseases, does hybrid revascularization provide similar outcomes to conventional coronary artery bypass grafting?

Interact Cardiovasc Thorac Surg 2021 May 7. Epub 2021 May 7.

Department of Cardiothoracic Surgery, Liverpool Heart and Chest Hospital, Liverpool, UK.

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: In [patients with multivessel coronary artery diseases (CAD)] is [hybrid revascularization (HCR)] equal to [coronary artery bypass grafting (CABG)] in regard to [mortality, myocardial infarction, stroke and target vessel revascularization (TVR)]? Three-hundred and fifty-five papers were found using the reported search, of which 8 represented the best evidence to answer the question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Read More

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