Multicenter randomized controlled trial
PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end colostomy; the PREVENT trial: study protocol for a multicenter randomized controlled trial
... single-blind, multicenter, randomized controlled trial is to determine if parastomal herniation is prevented by the prophylactic placement during open surgery of a polypropylene mesh around a ...
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The OPVI trial – perioperative hemodynamic optimization using the plethysmographic variability index in orthopedic surgery: study protocol for a multicenter randomized controlled trial
... enrollment of the first 200 patients, to check the length of hospital stay after surgery in each group and perform a futility assessment with conditional power. We antici- pate no missing data for the primary outcome ...
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The OPERA trial comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial
... A randomized controlled study authored by Squadrone and colleagues [11] demonstrated that application of con- tinuous positive airway pressure (CPAP) may reduce the need for reintubation, pneumonia and ...
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Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered
... Background: Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately ...
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Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial
... Notwithstanding the impact of PCT to improve diagnosis and antibiotic use in LRTI, its prognostic value on admis- sion to predict complications from LRTI is limited. Other biomarkers may have better potential in the ...
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Changes in CVD risk factors in the activity counseling trial
... Counseling Trial (ACT) on CVD risk factors, to examine whether changes in CVD risk factors differed according to baseline risk factor status, and to examine whether changes in fitness were associated with changes ...
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Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol)
... a multicenter randomized controlled trial to determine whether the efficacy of laparoscopic sacrohysteropexy is similar to vaginal sacrospinous hyster- opexy in women with symptomatic uterine ...
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Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial
... pragmatic, multicenter, randomized controlled trial is therefore needed to assess the true effectiveness and benefits of EM guided nasoenteral feeding tube placement in the surgical ...
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Use of probiotics in the treatment of severe acute pancreatitis: a systematic review and meta analysis of randomized controlled trials
... PROPATRIA trial (probiotic prophy- laxis in patients with predicted severe acute pancreatitis), published in 2008 (a multicenter randomized controlled trial (RCT) dominated by the Dutch ...
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A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial)
... therapeutic trial is a randomized placebo-controlled, double-blind study, but with the interventions used in the APPAC trial the concealment would not be possible and therefore a ...
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Minocycline and celecoxib as adjunctive treatments for bipolar depression: a study protocol for a multicenter factorial design randomized controlled trial
... this trial will lead to increased treatment options for patients who experience bipolar depression, a condition that is often highly debilitat- ing and challenging to ...
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Heliox Therapy in Bronchiolitis: Phase III Multicenter Double-Blind Randomized Controlled Trial
... the trial clinical report forms to allow analysis of LoT in the FM and NC ...across trial centers: gas A or B 6 oxygen humidi fi ed via MR850 (Fisher & Paykel Healthcare), minimal handling, attention to ...
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SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX trial): study design of an international multicenter randomized double blinded controlled trial of high dose sodium selenite administration in high risk cardiac surgical patients
... Patients will receive daily perioperative treatment of either high-dose sodium selenite or placebo. As with our previ- ously referenced preliminary studies, all patients will re- ceive an intravenous bolus of 2,000 μg ...
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Ocriplasmin for symptomatic vitreomacular adhesion: an evidence-based review of its potential
... This Phase II, multicenter, randomized, double-masked, placebo-controlled, parallel-group trial combined features of the previous two studies. Three doses of ocriplasmin (25 µ g, 75 µ g, and ...
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Evaluating the use of fibrin glue for sealing low output enterocutaneous fistulas: study protocol for a randomized controlled trial
... Background: The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract ...
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Minimally invasive versus open pancreatoduodenectomy (LEOPARD 2): study protocol for a randomized controlled trial
... a randomized controlled, parallel-group, patient-blinded, multicenter, phase 2/3, superiority trial in centers that completed the Dutch Pancreatic Cancer Group LAELAPS-2 training program for ...
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Treatment duration of febrile urinary tract infection (FUTIRST trial): a randomized placebo controlled multicenter trial comparing short (7 days) antibiotic treatment with conventional treatment (14 days)
... a trial as ...this trial it might be that men with febrile UTI have indeed acute ...a trial evaluating the optimal treatment duration is even more relevant in this population ...
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Improvement of migraine symptoms with a proprietary supplement containing riboflavin, magnesium and Q10: a randomized, placebo-controlled, double-blind, multicenter trial
... center study. After screening, patients underwent a one- month baseline period without treatment to verify that they had more than 3 migraine attacks but not more than 10 days with migraine or non-migraine headaches. The ...
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Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial
... Because there are several exclusion criteria in this trial, the patients are selected, and the results will not be ap- plicable to all patients presenting with an adhesive SBO. These exclusion criteria, however, ...
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Protocol for German trial of Acyclovir and corticosteroids in Herpes-simplex-virus-encephalitis (GACHE): a multicenter, multinational, randomized, double-blind, placebo-controlled German, Austrian and Dutch trial [ISRCTN45122933]
... prospective, multicenter, randomized, clinical trial has demonstrated the beneficial effect of adjuvant corticosteroids for the treatment of bac- terial meningitis ...
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