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Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial)
BackgroundIncisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of...
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Dreaming during gastrointestinal endoscopy under propofol, ciprofol, or remimazolam anesthesia: study protocol for a parallel-design double-blind, single-center trial
BackgroundDreaming sometimes occurs during sedation. It has been reported that factors such as different anesthetics, depth of anesthesia, age, sex,...
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A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS)
BackgroundPatient satisfaction has been positively associated with adherence which is expected to impact outcomes. Although vital for successful...
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Personalized, interdisciplinary patient pathway for cross-sector care of multimorbid patients (eliPfad trial): study protocol for a randomized controlled trial
BackgroundMultimorbid and frail elderly patients often carry a high burden of treatment. Hospitalization due to the onset of an acute illness can...
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Modified ultrasound scalpel haemorrhoidectomy versus conventional haemorrhoidectomy for mixed haemorrhoids: a study protocol for a single-blind randomised controlled trial
BackgroundHaemorrhoids are common and frequently occurring diseases in the clinical setting, and severe haemorrhoids require surgical treatment....
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Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer’s Disease
BackgroundLecanemab is a humanized IgG1 monoclonal antibody binding with high affinity to amyloid-beta protein protofibrils. In phase 3 development,...
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Genicular Artery Embolisation in Patients with Osteoarthritis of the Knee (GENESIS 2): Protocol for a Double-Blind Randomised Sham-Controlled Trial
Knee osteoarthritis is a leading cause of chronic disability and economic burden. In many patients who are not surgical candidates, existing...
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Single Versus Second Observer vs Artificial Intelligence to Increase the ADENOMA Detection Rate of Colonoscopy—A Network Analysis
Background and AimsScreening colonoscopy has significantly contributed to the reduction of the incidence of colorectal cancer (CRC) and its...
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Bright light therapy versus physical exercise to prevent co-occurring depression in adolescents and young adults with attention-deficit/hyperactivity disorder: a multicentre, three-arm, randomised controlled, pilot phase-IIa trial
AbstractDepression is common in attention-deficit/hyperactivity disorder (ADHD), but preventive behavioural interventions are lacking. This...
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Prednisolone Versus Colchicine for Acute Gout in Primary Care (COPAGO): protocol for a two-arm multicentre, pragmatic, prospective, randomized, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design
BackgroundGout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute...
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A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment or mild Alzheimer’s disease dementia (ROMEMA): study protocol of a double-blind, randomized, placebo-controlled, between-subjects trial
BackgroundResearch into the neurobiological underpinnings of learning and memory has demonstrated the cognitive-enhancing effects associated with...
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SPIOMET4HEALTH—efficacy, tolerability and safety of lifestyle intervention plus a fixed dose combination of spironolactone, pioglitazone and metformin (SPIOMET) for adolescent girls and young women with polycystic ovary syndrome: study protocol for a multicentre, randomised, double-blind, placebo-controlled, four-arm, parallel-group, phase II clinical trial
BackgroundPolycystic ovary syndrome (PCOS) is the most prevalent, chronic endocrine-metabolic disorder of adolescents and young women (AYAs),...
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Does functional planning, 3D templating and patient-specific instrumentation improve accuracy in total hip replacement?— a randomized controlled trial
AimsDebate continues as to the optimal orientation of the acetabular component in total hip arthroplasty (THA) and how to reliably achieve this. The...
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The first experimental study of transference work–in teenagers (FEST–IT): a multicentre, observer- and patient-blind, randomised controlled component study
BackgroundLittle is known about the influence on outcome of exploration of the patient-therapist relationship (that is, transference work) in...
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Evaluation of the efficacy and safety of conventional and biportal endoscopic decompressive laminectomy in patients with lumbar spinal stenosis (ENDO-B trial): a protocol for a prospective, randomized, assessor-blind, multicenter trial
BackgroundRecent studies on biportal endoscopic spine surgery in patients with lumbar spinal stenosis have reported good clinical results. However,...
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Assessing the Impact of an Artificial Intelligence-Based Model for Intracranial Aneurysm Detection in CT Angiography on Patient Diagnosis and Outcomes (IDEAL Study)—a protocol for a multicenter, double-blinded randomized controlled trial
BackgroundThis multicenter, double-blinded, randomized controlled trial (RCT) aims to assess the impact of an artificial intelligence (AI)-based...
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Improving eye care quality through brief verbal intervention on optometry service provider by using unannounced standardized patient with refractive error: study protocol for a randomized controlled trial
BackgroundImproper refractive correction can be harmful to eye health, aggravating the burden of vision impairment. During most optometry clinical...
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Treatment of Impetigo with Antiseptics—Replacing Antibiotics (TIARA) trial: a single blind randomised controlled trial in school health clinics within socioeconomically disadvantaged communities in New Zealand
BackgroundImpetigo is a common and contagious bacterial skin infection, affecting children worldwide, but it is particularly prevalent in...
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Efficacy of combined orthokeratology and 0.01% atropine for myopia control: the study protocol for a randomized, controlled, double-blind, and multicenter trial
BackgroundThe prevalence of myopia is increasing worldwide and is presently recognized as a major public health issue. Researchers and clinicians...
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CLEAR – clozapine in early psychosis: study protocol for a multi-centre, randomised controlled trial of clozapine vs other antipsychotics for young people with treatment resistant schizophrenia in real world settings
BackgroundClozapine is an antipsychotic drug with unique efficacy, and it is the only recommended treatment for treatment-resistant schizophrenia...
