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Efficacy of heel lifts for mid-portion Achilles tendinopathy (the LIFT trial): study protocol for a randomised controlled trial
BackgroundMid-portion Achilles tendinopathy is a common condition, characterised by localised Achilles tendon load-related pain and dysfunction....
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Anthracycline-induced cardiotoxicity in patients with early-stage breast cancer: the Canadian Cancer Trials Group (CCTG) MA.21 experience
PurposeAnthracyclines are frequently used in adjuvant treatment for early-stage breast cancer (ESBC). The purpose of this study was to evaluate...
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Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial
BackgroundPeople with serious mental illness (SMI) and people with intellectual disabilities/developmental disabilities (ID/DD) are at higher risk...
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Characteristics of two different cryoballoon systems for treatment of paroxysmal atrial fibrillation: study protocol for a multicenter randomized controlled trial (CONTRAST-CRYO Trial)
BackgroundSingle-shot pulmonary vein isolation (PVI) utilizing cryothermal energy is an effective and safe treatment for atrial fibrillation (AF)...
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Implementation of social needs screening for minoritized patients newly diagnosed with breast cancer: a mixed methods evaluation in a pragmatic patient navigation trial
BackgroundSocial needs inhibit receipt of timely medical care. Social needs screening is a vital part of comprehensive cancer care, and patient...
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Influence of CReatine supplementation on mUScle mass and strength after stroke (ICaRUS Stroke Trial): study protocol for a randomized controlled trial
BackgroundStroke is a leading cause of mortality and disability, and its sequelae are associated with inadequate food intake which can lead to...
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BE-WEL trial (breast: evaluation of weight and exercise for lymphoedema) testing weight control and exercise programmes for women with breast cancer related lymphoedema: a feasibility trial
PurposeA combined body weight loss and upper body/arm exercise programme is a potential strategy for managing Breast cancer related lymphoedema...
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Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET
BackgroundThe current standard of care (SoC) for the initial treatment of unresectable or metastatic well-differentiated gastroenteropancreatic...
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Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial)
BackgroundExperts recommend that treatment for substance use disorder (SUD) be integrated into primary care. The Digital Therapeutics for Opioids and...
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Supplementation with antioxidant micronutrients in pregnant women with obesity: a randomized controlled trial
Background/ObjectiveObesity increases maternal morbidity and adversely affects child health. Maternal inflammation may play a role in adverse...
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Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial
BackgroundOesophageal cancer (EC) is the sixth leading cause of cancer death worldwide. Oesophageal resection is the only curative treatment option...
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Blood calprotectin as a biomarker for infection and sepsis – the prospective CASCADE trial
BackgroundEarly in the host-response to infection, neutrophils release calprotectin, triggering several immune signalling cascades. In acute...
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Attenuating human fear memory retention with minocycline: a randomized placebo-controlled trial
Pavlovian fear conditioning is widely used as a pre-clinical model to investigate methods for prevention and treatment of anxiety and stress-related...
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The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients’ stroke risk and preoperative atrial fibrillation status
BackgroundSurgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients....
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Transcranial alternating current stimulation improves quality of life in Parkinson’s disease: study protocol for a randomized, double-blind, controlled trial
BackgroundThe neural cells in the brains of patients with Parkinson’s disease (PWP) display aberrant synchronized oscillatory activity within the...
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Nurse-Guided Maternal Interventional Package for Neonatal Stress–A Randomized Controlled Trial
ObjectiveTo assess the role of nurse-guided maternal interventional package for reducing stress behaviour among preterm neonates admitted in neonatal...
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Individualized rotation of left double lumen endobronchial tube to improve placement success rate: a randomized controlled trial
BackgroundIn conventional practice, the left double lumen tube (DLT) is rotated 90° counterclockwise when the endobronchial cuff passes glottis....
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Effect of spinal orthosis on clinical outcomes of patients after oblique lumbar interbody fusion: a randomized controlled trial study protocol
BackgroundOblique lumbar interbody fusion (OLIF) is an internationally popular minimally invasive technology for the treatment of various lumbar...
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Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery
BackgroundChildren undergoing cardiac surgery are at risk for acute kidney injury (AKI) and cardiac dysfunction. Opportunity exists in protecting end...
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Platelet reactivity in young children undergoing congenital heart disease surgery: a NITRIC randomized clinical trial substudy
IntroductionThe international NITRIC trial studied the hypothesis that nitric oxide (NO) applied into the cardiopulmonary bypass (CPB) oxygenator in...