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Placebo Controlled Trial Of SOM230 For The Reduction Of Post-Pancreatectomy Fistula, Leak, And Abscess PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Placebo Controlled Trial Of SOM230 For The Reduction Of Post-Pancreatectomy Fistula, Leak, And Abscess articles that have been published worldwide.
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Morbidity following pancreatectomy is commonly due to leakage of exocrine secretions resulting in abscess or pancreatic fistula (PF). Previously, we authored a double-blind randomized controlled trial demonstrating perioperative pasireotide administration lowers abscess or PF formation by over 50%. Accordingly, we adopted pasireotide usage as standard practice following pancreatectomy in October 2014 and hypothesized a similar PF/abscess rate reduction would be observed.
Pancreatic fistula remains a morbid complication after pancreatectomy. Since the proposed mechanism of pancreatic fistula is different between pancreaticoduodenectomy and distal pancreatectomy, we hypothesized that pancreatic gland texture and duct size are not associated with pancreatic fistula after distal pancreatectomy.
This trial followed a structured nationwide training program in minimally invasive distal pancreatectomy (MIDP), according to the IDEAL framework for surgical innovation, and aimed to compare time to functional recovery after minimally invasive and open distal pancreatectomy (ODP).
Postoperative pancreatic fistula (POPF) remains a frequent problem especially after distal pancreatectomy. The application of 2-octyl cyanoacrylate showed promising results in the reduction of POPF after pancreatoduodenectomy prompting an expansion of this technique to distal pancreatectomy. Thus, the objective of the current study was to assess safety, feasibility and preliminary efficacy of an intraoperative 2-octyl cyanoacrylate application after distal pancreatectomy.
Crossover double blind, randomized placebo-controlled trial.
Symptoms of bloating, discomfort and altered bowel function persist post-colonoscopy in up to 20% of patients. A previous randomized controlled trial of probiotics for post-colonoscopy symptoms has demonstrated a reduction in duration of pain with the use of probiotics. This was performed with air insufflation and the question was asked whether the effect would persist with the use of carbon dioxide to insufflate the colon.
The predictive risk factors of clinically relevant pancreatic fistula (CR-PF) following distal pancreatectomy (DP) remain to be identified.
The role of postoperative day 1 drain fluid amylase level in predicting clinically relevant postoperative pancreatic fistula is under investigation. In a previous multicenter study conducted on 338 patients undergoing distal pancreatectomy, day 1 drain fluid amylase level has been correlated to the development of a clinically relevant pancreatic fistula and an amylase value of 2,000 U/L was found to be most predictive of the development of clinically relevant postoperative pancreatic fistula. Our objective ...
The placebo-controlled phase-2 REGOSARC trial demonstrated the efficacy of regorafenib in patients with leiomyosarcoma, synovial sarcoma and other non-adipocytic sarcoma but not in liposarcoma. Patients initially allocated to placebo were allowed to receive regorafenib after progression. We report here an updated analysis of the trial including evaluation of regorafenib activity after cross-over.
The growing need for symptomatic treatment of post-traumatic neuropathic pain (PTNP) continues to be unmet. Studies evaluating the efficacy of pregabalin for reducing neuropathic pain following trauma and surgery yielded positive results over ≤ 8-week treatment. To assess the efficacy and tolerability of pregabalin over 3 months in patients with PTNP, a randomized, double-blind, placebo-controlled, parallel-group trial evaluated patients with PTNP at 101 centers in 11 countries-the longest, largest suc...
Pancreatic fistula/PF is the most frequent and feared complication after distal pancreatectomy/DP. However, the safest technique of pancreatic stump closure remains an ongoing debate. Here, we aimed to compare the safety of different pancreatic stump closure techniques for preventing PF during DP.
The objective of this study was to evaluate the electrocardiographic effects of hawthorn in healthy adult volunteers. It was double-blind cross-over trial randomized 20 healthy adult volunteers to receive either a single oral 160-mg dose of hawthorn or matching placebo. Triplicate 12-lead electrocardiograms were taken before treatment and at 1-, 2-, 4-, and 6-hr post-dose. Following at least a 7-day washout period, participants were crossed over to the opposing treatment arm and had the measurements repeate...
We tested whether intervention with atorvastatin affects the prostate beneficially compared with placebo in men with prostate cancer in a randomized clinical trial. A total of 160 statin-naïve prostate cancer patients scheduled for radical prostatectomy were randomized to use 80mg atorvastatin or placebo daily from recruitment to surgery for a median of 27 d. Blinding was maintained throughout the trial. In total, 158 men completed the follow-up, with 96% compliance. Overall, atorvastatin did not significa...
This randomized controlled trial (RCT) aimed to compare the clinical outcomes of thoracolumbar burst fractures (TLBFs) treated with open reduction and internal fixation via the posterior paraspinal muscle approach (PPMA) and the post-middle approach (PA).
Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha).
The aim of this multi-centre, randomised, double-blind, placebo-controlled trial was to compare the efficacy and safety of the fixed combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine (study drug marketed as Dorithricin ) in repeat dosing for 3 days to match placebo lozenges in the treatment of acute pharyngitis in adults.
total pancreatectomy with intraportal islet autotransplantation (TPIAT) rather than partial pancreatectomy could represent a major shift in the management of patients with resectable pancreatic ductal adenocarcinoma (PDAC) when risks of postoperative pancreatic fistula are well identified. This approach provides a theoretical risk of tumor cell dissemination when islet cells are transplanted into the portal vein. Our objective was to demonstrate the safety of TPIAT in PDAC in a mouse preclinical model of su...
Vitamin D supplementation is often used in the prevention and treatment of osteoporosis, but the role of vitamin D has lately been questioned. We aimed to investigate the effect of 3 months of daily vitamin D3 supplementation (70 µg [2800 IU] vs. placebo) initiated in winter months on bone health. This study is a double-blinded placebo-controlled randomized trial. Bone health was assessed by bone turnover markers, DXA, HRpQCT, and QCT scans. The participants were 81 healthy postmenopausal women with low...
Only two, small placebo-controlled trials on peanut- oral immunotherapy (OIT) have been published.
Prospects for no-option, end-stage peripheral artery disease (PAD) patients remain poor. Although results from open and semiblinded studies fuel hope for cell-based strategies in no-option patients, so far conclusions from the available placebo-controlled studies are not supportive. With the intention to end the remaining controversy with regard to cell therapy for PAD we conducted a confirmatory, double-blinded randomized placebo-controlled phase 3 trial.
Cytomegalovirus (CMV) infection is a common complication of allogeneic hematopoietic-cell transplantation (HCT). In this trial we randomized adult CMV-seropositive HCT patients without CMV viremia at screening 2:1 to receive brincidofovir or placebo until Week 14 post-HCT. Randomization was stratified by center and risk of CMV infection. Patients were assessed weekly through Week 15 and every third week thereafter through Week 24 post-HCT. Patients who developed clinically-significant CMV infection (CS-CMVi...
One in three clinical trial patients with major depressive disorder report symptomatic improvement with placebo. Strategies to mitigate the effect of placebo responses have focused on modifying study design with variable success. Identifying and excluding or controlling for individuals with a high likelihood of responding to placebo may improve clinical trial efficiency and avoid unnecessary medication trials.
Effect of high-dose ginsenoside complex (UG0712) supplementation on physical performance of healthy adults during a 12-week supervised exercise program: A randomized placebo-controlled clinical trial.
Ginseng has been used as an ergogenic agent, although evidence for its effectiveness is weak. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a ginsenoside complex (UG0712) on changes in exercise performance.
An unbalanced intestinal microbiota may mediate activation of the inflammatory pathways seen in psoriatic arthritis (PsA). A randomised, placebo-controlled trial of faecal microbiota transplantation (FMT) infused into the small intestine of patients with PsA with active peripheral disease who are non-responsive to methotrexate (MTX) treatment will be conducted. The objective is to explore clinical aspects associated with FMT performed in patients with PsA.
Small observational studies suggest that local glucocorticoid (GC) injection may be effective in the management of the greater trochanteric pain syndrome (GTPS). The objective was to perform the first randomised double-blind placebo-controlled trial to investigate the efficacy of local GC injection in the management of GTPS. The trial was conducted between November 2011 and May 2015. Inclusion criteria included lateral hip pain (LHP) for greater than 1 month, a LHP score of ≥ 4/10 and typical LHP repro...
Microbiome studies suggest the presence of an interaction between the human gut microbiome and soil-transmitted helminth. Upon deworming, a complex interaction between the anthelminthic drug, helminths and microbiome composition might occur. To dissect this, we analyse the changes that take place in the gut bacteria profiles in samples from a double blind placebo controlled trial conducted in an area endemic for soil transmitted helminths in Indonesia.