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Gastroenterology randomized control trial

Stephen A Harrison, Mary E Rinella, Manal F Abdelmalek, James F Trotter, Angelo H Paredes, Hays L Arnold, Marcelo Kugelmas, Mustafa R Bashir, Mark J Jaros, Lei Ling, Stephen J Rossi, Alex M DePaoli, Rohit Loomba
BACKGROUND: Non-alcoholic steatohepatitis is a chronic liver disease characterised by the presence of hepatic steatosis, inflammation, and hepatocellular injury, for which no Food and Drug Administration (FDA)-approved treatment exists. FGF19 is a hormone that regulates bile acid synthesis and glucose homoeostasis. We aimed to assess the safety and efficacy of NGM282, an engineered FGF19 analogue, for the treatment of non-alcoholic steatohepatitis. METHODS: In this randomised, double-blind, placebo-controlled, phase 2 study, we recruited patients aged 18-75 years with biopsy-confirmed non-alcoholic steatohepatitis as defined by the non-alcoholic steatohepatitis clinical research network histological scoring system, from hospitals and gastroenterology and liver clinics in Australia and the USA...
March 5, 2018: Lancet
Rachel Rosen, Yvan Vandenplas, Maartje Singendonk, Michael Cabana, Carlo DiLorenzo, Frederic Gottrand, Sandeep Gupta, Miranda Langendam, Annamaria Staiano, Nikhil Thapar, Neelesh Tipnis, Merit Tabbers
This document serves as an update of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) 2009 clinical guidelines for the diagnosis and management of gastroesophageal reflux disease (GERD) in infants and children and is intended to be applied in daily practice and as a basis for clinical trials. Eight clinical questions addressing diagnostic, therapeutic and prognostic topics were formulated...
March 2018: Journal of Pediatric Gastroenterology and Nutrition
Julie R Brahmer, Christina Lacchetti, Bryan J Schneider, Michael B Atkins, Kelly J Brassil, Jeffrey M Caterino, Ian Chau, Marc S Ernstoff, Jennifer M Gardner, Pamela Ginex, Sigrun Hallmeyer, Jennifer Holter Chakrabarty, Natasha B Leighl, Jennifer S Mammen, David F McDermott, Aung Naing, Loretta J Nastoupil, Tanyanika Phillips, Laura D Porter, Igor Puzanov, Cristina A Reichner, Bianca D Santomasso, Carole Seigel, Alexander Spira, Maria E Suarez-Almazor, Yinghong Wang, Jeffrey S Weber, Jedd D Wolchok, John A Thompson
Purpose To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Methods A multidisciplinary, multi-organizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, nursing, trialist, and advocacy was convened to develop the clinical practice guideline. Guideline development involved a systematic review of the literature and an informal consensus process...
February 14, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Jing-Xiu Li, Yang Li, Shu-Jun Yan, Bai-He Han, Zhao-Yan Song, Wei Song, Shi-Hao Liu, Ji-Wei Guo, Shuo Yin, Ye-Ping Chen, De-Jun Xia, Xin Li, Xue-Qi Li, En-Ze Jin
A challenge for antithrombotic treatment is patients who present with atrial fibrillation (AF) and acute coronary syndrome, particularly in patients who have undergone coronary percutaneous intervention with stenting (PCIS). In the present study, a total of nine observational trials published prior to July 2017 that investigated the effects of dual antiplatelet therapy (DAPT; aspirin + clopidogrel) and triple oral antithrombotic therapy (TOAT; DAPT + warfarin) among patients with AF concurrent to PCIS were collected from the Medline, Cochrane and Embase databases and conference proceedings of cardiology, gastroenterology and neurology meetings...
February 2018: Biomedical Reports
Kosuke Ichida, Hiroshi Noda, Rina Kikugawa, Fumi Hasegawa, Tamotsu Obitsu, Daisuke Ishioka, Rintaro Fukuda, Ayuha Yoshizawa, Shingo Tsujinaka, Toshiki Rikiyama
BACKGROUND: Surgical site infection is one of the most common postoperative complications after gastroenterologic surgery. This study investigated the effect of triclosan-coated sutures in decreasing the incidence of surgical site infections after abdominal wall closure in gastroenterologic surgery. METHODS: A prospective, double-blind, randomized, controlled parallel adaptive group-sequential superiority trial was conducted from March 2014 to March 2017 in a single center...
February 2, 2018: Surgery
Rachel Rosen, Yvan Vandenplas, Maartje Singendonk, Michael Cabana, Carlo Di Lorenzo, Frederic Gottrand, Sandeep Gupta, Miranda Langendam, Annamaria Staiano, Nikhil Thapar, Neelesh Tipnis, Merit Tabbers
This document serves as an update of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) 2009 clinical guidelines for the diagnosis and management of gastroesophageal reflux disease (GERD) in infants and children and is intended to be applied in daily practice and as a basis for clinical trials. Eight clinical questions addressing diagnostic, therapeutic and prognostic topics were formulated...
January 25, 2018: Journal of Pediatric Gastroenterology and Nutrition
Nadia Mohammed Vashist, Mark Samaan, Mahmoud H Mosli, Claire E Parker, John K MacDonald, Sigrid A Nelson, G Y Zou, Brian G Feagan, Reena Khanna, Vipul Jairath
BACKGROUND: Endoscopic assessment of mucosal disease activity is routinely used to determine eligibility and response to therapy in clinical trials of ulcerative colitis. The operating properties of the existing endoscopic scoring indices are unclear. OBJECTIVES: A systematic review was undertaken to evaluate the development and operating characteristics of endoscopic scoring indices for the evaluation of ulcerative colitis. SEARCH METHODS: We searched MEDLINE, Embase and CENTRAL from inception to 5 July 2016...
January 16, 2018: Cochrane Database of Systematic Reviews
Q Zhou, M H Zuo, Q W Li, Y T Tian, Y B Xie, Y B Wang, G Y Yang, Y J Ye, P Guo, J P Liu, Z L Liu, C An, T Zhou, Z Tian, C B Liu, Y Hu, X Y Chi, Y Shen, Y Xia, K W Hu
Objective: To investigate the safety and efficacy of the Weitan Waifu patch on the postsurgical gastroparesis syndrome (PGS) of gastrointestinal cancer. Methods: The multi-center, double-blind, randomized controlled trial was conducted with superiority design. Patients with PGS of gastrointestinal cancer diagnosed in 4 AAA hospitals and the abdominal symptom manifested as cold syndrome by Chinese local syndrome differentiation were recruited. These patients were randomly divided into two groups according to 1∶1 proportion...
December 23, 2017: Zhonghua Zhong Liu za Zhi [Chinese Journal of Oncology]
Michael Doulberis, Georgios Kotronis, Robert Thomann, Stergios A Polyzos, Marina Boziki, Dimitra Gialamprinou, Georgia Deretzi, Panagiotis Katsinelos, Jannis Kountouras
BACKGROUND: Helicobacter pylori has changed radically gastroenterologic world, offering a new concept in patients' management. Over time, more medical data gave rise to diverse distant, extragastric manifestations and interactions of the "new" discovered bacterium. Special interest appeared within the field of neurodegenerative diseases and particularly Alzheimer's disease, as the latter and Helicobacter pylori infection are associated with a large public health burden and Alzheimer's disease ranks as the leading cause of disability...
February 2018: Helicobacter
Dorta Guridi Zaily, Castellanos Fernandez Marlen, Dueñas-Carrera Santiago, Martínez Donato Gillian, Valenzuela Silva Carmen, Cinza Estevez Zurina, Arús Soler Enrique R, Alvarez-Lajonchere Liz, González Fabián Lisset, Lazo Del Vallín Sacha, Ferrer Bataille Elena
Background: An estimated 170 million individuals worldwide are infected with the hepatitis C virus (HCV). Although treatment options using a combination of pegylated interferon and ribavirin (P-IFN/RBV) are available, sustained clearance of the virus is only achieved in approximately 40% of individuals infected with HCV genotype 1. Recent advances in the treatment of HCV using directly acting antiviral agents have been achieved; however, treatment can be very expensive and is associated with substantial side effects...
2017: Current Therapeutic Research, Clinical and Experimental
Ning Li, Hongliang Tian
Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or fecal infusion, consists of injection of a liquid filtrate of feces from a healthy donor into the gastrointestinal tract of a recipient individual. FMT has been proposed as a therapeutic approach for functional diseases of the gastrointestinal tract by reestablishment of a wide diversity of intestinal flora. Clostridium difficile infection (CDI) treatment guideline from American Gastroenterology Association (AGA) recommends that FMT can be used as the treatment protocols of relapse CDI...
October 25, 2017: Zhonghua Wei Chang Wai Ke za Zhi, Chinese Journal of Gastrointestinal Surgery
Flloyd Carter, Majd Alsayb, John K Marshall, Yuhong Yuan
BACKGROUND: Diverticular disease is a common condition that increases in prevalence with age. Recent theories on the pathogenesis of diverticular inflammation have implicated chronic inflammation similar to that seen in ulcerative colitis. Mesalamine, or 5-aminosalicylic acid (5-ASA), is a mainstay of therapy for individuals with ulcerative colitis. Accordingly, 5-ASA has been studied for prevention of recurrent diverticulitis. OBJECTIVES: To evaluate the efficacy of mesalamine (5-ASA) for prevention of recurrent diverticulitis...
October 3, 2017: Cochrane Database of Systematic Reviews
James E Allen, Prashanth Vennalaganti, Neil Gupta, Benjamin Hornung, Abhishek Choudhary, Mohammad Titi, Benjamin R Alsop, Diego Lim, Prateek Sharma
BACKGROUND: The optimal method for teaching NBI International Colorectal Endoscopic (NICE) criteria to medical trainees is unknown. METHODS: Trainees (medical students, residents, and gastroenterology fellows) were randomized to 2 groups (in-classroom vs. self-directed training). Teaching phase: A standardized presentation was developed about narrow band imaging (NBI) and NICE criteria. The in-class teaching group attended a single live-teaching session (with NBI expert)...
September 22, 2017: Journal of Clinical Gastroenterology
Henryk Szymański, Hania Szajewska
BACKGROUND: Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. However, despite proven efficacy, it remains underused. This is because oral rehydration solution neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness. Hence, there is interest in adjunctive treatments. According to the 2014 guidelines developed by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, the use of the following probiotics may be considered in the management of children with AGE in addition to rehydration therapy: Lactobacillus rhamnosus GG (low quality of evidence; strong recommendation) and Saccharomyces boulardii (low quality of evidence; strong recommendation)...
August 23, 2017: JMIR Research Protocols
Anita Padam, Neetu Sharma, O S K S Sastri, Shivani Mahajan, Rajesh Sharma, Deepak Sharma
BACKGROUND: A high level of preoperative anxiety is common among patients undergoing medical and surgical procedures. Anxiety impacts of gastroenterological procedures on psychological and physiological responses are worth consideration. AIMS AND OBJECTIVES: To analyze the effect of listening to Vedic chants and Indian classical instrumental music on anxiety levels and on blood pressure (BP), heart rate (HR), and oxygen saturation in patients undergoing upper gastrointestinal (GI) endoscopy...
April 2017: Indian Journal of Psychiatry
Katja Kovacic, Keri Hainsworth, Manu Sood, Gisela Chelimsky, Rachel Unteutsch, Melodee Nugent, Pippa Simpson, Adrian Miranda
BACKGROUND: Development of safe and effective therapies for paediatric abdominal pain-related functional gastrointestinal disorders is needed. A non-invasive, US Food and Drug Administration-cleared device (Neuro-Stim, Innovative Health Solutions, IN, USA) delivers percutaneous electrical nerve field stimulation (PENFS) in the external ear to modulate central pain pathways. In this study, we evaluated the efficacy of PENFS in adolescents with abdominal pain-related functional gastrointestinal disorders...
October 2017: Lancet. Gastroenterology & Hepatology
Claudio Romano, Myriam van Wynckel, Jessie Hulst, Ilse Broekaert, Jiri Bronsky, Luigi Dall'Oglio, Nataša F Mis, Iva Hojsak, Rok Orel, Alexandra Papadopoulou, Michela Schaeppi, Nikhil Thapar, Michael Wilschanski, Peter Sullivan, Frédéric Gottrand
OBJECTIVES: Feeding difficulties are frequent in children with neurological impairments and can be associated with undernutrition, growth failure, micronutrients deficiencies, osteopenia, and nutritional comorbidities. Gastrointestinal problems including gastroesophageal reflux disease, constipation, and dysphagia are also frequent in this population and affect quality of life and nutritional status. There is currently a lack of a systematic approach to the care of these patients. With this report, European Society of Gastroenterology, Hepatology and Nutrition aims to develop uniform guidelines for the management of the gastroenterological and nutritional problems in children with neurological impairment...
August 2017: Journal of Pediatric Gastroenterology and Nutrition
William D Chey
Many nonpharmacologic and pharmacologic therapies are available to manage irritable bowel syndrome (IBS) and chronic idiopathic constipation (CIC). The American College of Gastroenterology (ACG) regularly publishes reviews on IBS and CIC therapies. The most recent of these reviews was published by the ACG Task Force on the Management of Functional Bowel Disorders in 2014. The key objective of this review was to evaluate the efficacy of therapies for IBS or CIC compared with placebo or no treatment in randomized controlled trials...
February 2017: Gastroenterology & Hepatology
Nicolas Kerckhove, Julien Scanzi, Bruno Pereira, Denis Ardid, Michel Dapoigny
INTRODUCTION: Irritable bowel syndrome (IBS) is characterised by the association of abdominal chronic pain with bowel habit disorders in the absence of identifiable organic disease. This is the first reason for consultation in gastroenterology, with an estimated prevalence of 10%-15% in industrialised countries. Although this is a benign gastrointestinal disease, its chronicity profoundly impacts the patient's quality of life and causes considerable health spending. Actual medical treatments are poorly efficient on IBS-related abdominal pain, making it a major public health concern...
July 18, 2017: BMJ Open
Nilesh Chande, Noor Al Yatama, Tania Bhanji, Tran M Nguyen, John Wd McDonald, John K MacDonald
BACKGROUND: Lymphocytic colitis is a cause of chronic diarrhea. It is a subtype of microscopic colitis characterized by chronic, watery, non-bloody diarrhea and normal endoscopic and radiologic findings. The etiology of this disorder is unknown.Therapy is based mainly on case series and uncontrolled trials, or by extrapolation of data for treating collagenous colitis, a related disorder. This review is an update of a previously published Cochrane review. OBJECTIVES: To evaluate the efficacy and safety of treatments for clinically active lymphocytic colitis...
July 13, 2017: Cochrane Database of Systematic Reviews
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