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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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LapEmerge trial: study protocol for a laparoscopic approach for emergency colon resection—a multicenter, open label, randomized controlled trial
BackgroundDue to faster recovery and lower morbidity rates, laparoscopy has become the gold standard in elective colorectal surgery for both the...
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Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING)
BackgroundThe prevalence of sacroiliac joint pain (SIJP) is estimated to be 10–30% in patients with chronic low back pain. Numerous conservative and...
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Thoracic epidural analgesia in intensive care unit patients with acute pancreatitis: the EPIPAN multicenter randomized controlled trial
BackgroundFindings from preclinical studies and one pilot clinical trial suggest potential benefits of epidural analgesia in acute pancreatitis. We...
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Pain and Opioid Consumption After Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Secondary Analysis of a Multicenter Randomized Clinical Trial (LOGICA-Trial)
BackgroundLaparoscopic gastrectomy could reduce pain and opioid consumption, compared to open gastrectomy. However, it is difficult to judge the...
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Clinical Efficacy of Megadose Vitamin C in Sepsis: Protocol for a Multicenter Randomized Single-Blind Placebo-Controlled Clinical Trial
IntroductionSepsis is a severe disease with a complex pathogenesis and is an important factor in the mortality of patients in intensive care units...
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Efficacy of electroacupuncture therapy in patients with functional anorectal pain: study protocol for a multicenter randomized controlled trial
BackgroundSome Chinese scholars have initially explored the efficacy of electroacupuncture at Baliao acupoint in patients with functional anorectal...
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Efficacy and safety of heparin for sepsis-induced disseminated intravascular coagulation (HepSIC): study protocol for a multicenter randomized controlled trial
BackgroundDisseminated intravascular coagulation (DIC) occurs in 30–50% of septic patients and contributes to high mortality in the intensive care...
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The INCH-trial: a multicenter randomized controlled trial comparing short- and long-term outcomes of open and laparoscopic surgery for incisional hernia repair
BackgroundLaparoscopic incisional hernia repair is increasingly performed worldwide and expected to be superior to conventional open repair regarding...
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Physiological-based cord clam** in very preterm infants: the Aeration, Breathing, Clam** 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial
BackgroundMortality, cerebral injury, and necrotizing enterocolitis (NEC) are common complications of very preterm birth. An important risk factor...
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Efficacy of endoscopic submucosal resection with a ligation device for small rectal neuroendocrine tumor: study protocol of a multicenter open-label randomized control trial (BANDIT trial)
BackgroundEndoscopic resection is widely accepted as a local treatment for rectal neuroendocrine tumors sized ≤ 10 mm. However, there is no consensus...
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Radiographic evaluation of robot-assisted versus manual total hip arthroplasty: a multicenter randomized controlled trial
BackgroundThe effectiveness of robot-assisted surgery remains contentious due to the lack of high-quality randomized controlled trials (RCTs) to...
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Minimally invasive surgeries for spontaneous hypertensive intracerebral hemorrhage (MISICH): a multicenter randomized controlled trial
BackgroundIntracerebral hemorrhage (ICH) is a common stroke type with high morbidity and mortality. There are mainly three surgical methods for...
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Randomized, prospective, multicenter trial assessing the numen coil embolization system in the endovascular treatment of small intracranial aneurysms: outcomes from the CATCH Trial
Background and purposeThe CATCH (Coil Application Trial in China) trial was designed to assess the safety and efficacy of the Numen Coil Embolization...
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The effects of simulation-based education on undergraduate nursing students' competences: a multicenter randomized controlled trial
BackgroundEducation in nursing has noticed a positive effect of simulation-based education. There are many studies available on the effects of...
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MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial—study protocol for a MEFI Trial
BackgroundInternational guidelines of groin hernia treatment strongly recommend to fixate the mesh in large M3 medial defects during TAPP/TEP...
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BRASD trial: biomechanical reposition techniques in anterior shoulder dislocation—a randomized multicenter clinical trial
BackgroundBiomechanical reduction techniques for shoulder dislocations have demonstrated high reduction success rates with a limited pain experience...
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Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial
ObjectiveDescribe the effects of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial.
Study design ...
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Clinical Evaluation of MyoCare in Europe (CEME): study protocol for a prospective, multicenter, randomized, double-blinded, and controlled clinical trial
BackgroundMyopia prevalence has been increasing in the last decades, and its pathological consequences, including myopic maculopathy and high...
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Comparison of hemostatic ability between spray coagulation and forced coagulation modes in endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for multicenter randomized controlled trial (Spray-G trial)
BackgroundEndoscopic submucosal dissection (ESD) is the standard treatment for early gastric neoplasms (EGN). Controlling intraoperative bleeding is...
