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Marjan de Vries, Dagmar C M van Rijckevorsel, Kris C P Vissers, Oliver H G Wilder-Smith, Harry van Goor
BACKGROUND & AIMS: Delta-9-tetrahydrocannabinol (THC) is the most abundant cannabinoid from the plant Cannabis sativa. There is only equivocal evidence that THC has analgesic effects. We performed a phase 2 controlled trial to evaluate the analgesic efficacy, pharmacokinetics, safety, and tolerability of an oral tablet containing purified THC in patients with chronic abdominal pain. METHODS: Sixty-five patients with chronic abdominal pain for 3 months or more (numeric rating scale scores of 3 or more) after surgery or due to chronic pancreatitis were randomly assigned to groups given the THC tablet or identical matching placebos for 50-52 days...
October 5, 2016: Clinical Gastroenterology and Hepatology
Rachel Wodarski, Ada Delaney, Camilla Ultenius, Rosie Morland, Nick Andrews, Catherine Baastrup, Luke A Bryden, Ombretta Caspani, Thomas Christoph, Natalie J Gardiner, Wenlong Huang, Jeffrey D Kennedy, Suguru Koyama, Dominic Li, Marcin Ligocki, Annika Lindsten, Ian Machin, Anton Pekcec, Angela Robens, Sanziana M Rotariu, Sabrina Vo, Marta Segerdahl, Carina Stenfors, Camilla I Svensson, Rolf-Detlef Treede, Katsuhiro Uto, Kazumi Yamamoto, Kris Rutten, Andrew S C Rice
Burrowing, an ethologically relevant rodent behaviour, has been proposed as a novel outcome measure to assess the global impact of pain in rats. In a prospective multicentre study using male rats (Wistar, Sprague-Dawley), replication of suppressed burrowing behaviour in the complete Freund adjuvant (CFA)-induced model of inflammatory pain (unilateral, 1 mg/mL in 100 µL) was evaluated in 11 studies across 8 centres. Following a standard protocol, data from participating centres were collected centrally and analysed with a restricted maximum likelihood-based mixed model for repeated measures...
October 2016: Pain
Matthew L Singer, Kris Oreschak, Zachariah Rhinehart, Barrie D Robison
Zebrafish (Danio rerio) have emerged as a popular model for studying the pharmacology and behavior of anxiety. While there have been numerous studies documenting the anxiolytic and anxiogenic effects of common drugs in zebrafish, many do not report or test for behavioral differences between the sexes. Previous studies have indicated that males and females differ in their baseline level of anxiety. In this study, we test for a sex interaction with fluoxetine and nicotine. We exposed fish to system water (control), 10 mg/L fluoxetine, or 1 mg/L nicotine for three minutes prior to being subjected to four minutes in an open-field drop test...
2016: PeerJ
Elliot B Tapper, Bruce R Bacon, Michael P Curry, Douglas T Dieterich, Steven L Flamm, Lauren E Guest, Kris V Kowdley, Yoori Lee, Naoky C Tsai, Zobair M Younossi, Nezam H Afdhal
: Many patients with chronic hepatitis C virus (HCV) are on prolonged proton-pump inhibitor (PPI) therapy and wish to remain on PPI therapy once treatment for HCV starts. A preliminary report recently suggested decrease rates of sustained virological response (SVR) for patients taking concomitant PPI and ledipasvir/sofosbuvir (LDV/SOF). We sought to determine the effect of PPI use on the rate of SVR in a real-world cohort of 1,979 patients with chronic HCV treated with LDV/SOF. We collected clinical data and pharmacy dispensing records on patients taking 8, 12, or 24 weeks of LDV/SOF ± ribavirin (RBV)...
August 17, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
Frederik Nevens, Pietro Andreone, Giuseppe Mazzella, Simone I Strasser, Christopher Bowlus, Pietro Invernizzi, Joost P H Drenth, Paul J Pockros, Jaroslaw Regula, Ulrich Beuers, Michael Trauner, David E Jones, Annarosa Floreani, Simon Hohenester, Velimir Luketic, Mitchell Shiffman, Karel J van Erpecum, Victor Vargas, Catherine Vincent, Gideon M Hirschfield, Hemant Shah, Bettina Hansen, Keith D Lindor, Hanns-Ulrich Marschall, Kris V Kowdley, Roya Hooshmand-Rad, Tonya Marmon, Shawn Sheeron, Richard Pencek, Leigh MacConell, Mark Pruzanski, David Shapiro
BACKGROUND: Primary biliary cholangitis (formerly called primary biliary cirrhosis) can progress to cirrhosis and death despite ursodiol therapy. Alkaline phosphatase and bilirubin levels correlate with the risk of liver transplantation or death. Obeticholic acid, a farnesoid X receptor agonist, has shown potential benefit in patients with this disease. METHODS: In this 12-month, double-blind, placebo-controlled, phase 3 trial, we randomly assigned 217 patients who had an inadequate response to ursodiol or who found the side effects of ursodiol unacceptable to receive obeticholic acid at a dose of 10 mg (the 10-mg group), obeticholic acid at a dose of 5 mg with adjustment to 10 mg if applicable (the 5-10-mg group), or placebo...
August 18, 2016: New England Journal of Medicine
Edward Gane, Kris V Kowdley, David Pound, Catherine A M Stedman, Mitchell Davis, Kyle Etzkorn, Stuart C Gordon, David Bernstein, Gregory Everson, Maribel Rodriguez-Torres, Naoky Tsai, Omer Khalid, Jenny C Yang, Sophia Lu, Hadas Dvory-Sobol, Luisa M Stamm, Diana M Brainard, John G McHutchison, Myron Tong, Raymond T Chung, Kimberly Beavers, John E Poulos, Paul Y Kwo, Mindie H Nguyen
BACKGROUND & AIMS: Studies are needed to determine the optimal regimen for patients with chronic hepatitis C virus (HCV) genotype 2, 3, 4, or 6 infections whose prior course of antiviral therapy has failed, and the feasibility of shortening treatment duration. We performed a phase 2 study to determine the efficacy and safety of the combination of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857 in these patients...
July 30, 2016: Gastroenterology
Michel Hermans, Luc Van Gaal, Ingrid Rézette, Evis Daci, Karen MacDonald, Kris Denhaerynck, Stefaan Vancayzeele, Lut De Meester, Andreas Clemens, Brian Yee, Ivo Abraham
AIMS: To evaluate the real-world effectiveness of vildagliptin and vildagliptin/metformin, combined with patient engagement, on glycemic outcomes. Patient engagement included both clinicians' engaging patients through education and counseling; and patients' self-engagement through disease awareness, lifestyle changes, and medication adherence. METHODS: Prospective, observational, open-label, multi-center, pharmacoepidemiologic study of type 2 diabetes mellitus (T2DM) patients treated de novo with vildagliptin or vildagliptin/metformin...
July 4, 2016: Primary Care Diabetes
Christoph Sarrazin, Hadas Dvory-Sobol, Evguenia S Svarovskaia, Brian P Doehle, Phillip S Pang, Shu-Min Chuang, Julie Ma, Xiao Ding, Nezam H Afdhal, Kris V Kowdley, Edward J Gane, Eric Lawitz, Diana M Brainard, John G McHutchison, Michael D Miller, Hongmei Mo
BACKGROUND & AIMS: We evaluated the effects of baseline hepatitis C virus (HCV) NS5A, NS5B, and NS3 resistance-associated substitutions (RASs) on response to the combination of ledipasvir and sofosbuvir, with or without ribavirin, in patients with HCV genotype 1 infection. METHODS: We analyzed data from 2144 participants in phase 2 and 3 studies of patients with HCV genotype 1a or b infection who received the combination of ledipasvir (90 mg) and sofosbuvir (400 mg) (ledipasvir/sofosbuvir) once daily, with or without ribavirin twice daily...
September 2016: Gastroenterology
Kris Vermeylen, Joris De Puydt, Stefan Engelen, Eva Roofthooft, Filiep Soetens, Arne Neyrinck, Marc Van de Velde
BACKGROUND AND AIMS: A popliteal block is effective in managing postoperative pain for foot surgery, but since the duration of analgesia is limited following a single-shot popliteal fossa block technique, methods to prolong effective postoperative analgesia are mandatory. The aim of this study was to assess the effect of adjuvants to ropivacaine on the duration of sensory and motor block. METHODS: In this double-blind randomized placebo-controlled study, we evaluated the analgesic effect of clonidine or dexamethasone (DXM) when added to ropivacaine for hallux valgus surgery...
2016: Local and Regional Anesthesia
Kris Ann Baker, Rajan Lamichhane, Tek Lamichhane, David Rueda, Philip R Cunningham
Interactions between ribosomal proteins (rproteins) and ribosomal RNA (rRNA) facilitate the formation of functional ribosomes. S15 is a central domain primary binding protein that has been shown to trigger a cascade of conformational changes in 16S rRNA, forming the functional structure of the central domain. Previous biochemical and structural studies in vitro have revealed that S15 binds a three-way junction of helices 20, 21, and 22, including nucleotides 652-654 and 752-754. All junction nucleotides except 653 are highly conserved among the Bacteria...
September 11, 2016: Journal of Molecular Biology
Kristina Vermeersch, Maria Gabrovska, Griet Deslypere, Ingel K Demedts, Hans Slabbynck, Joseph Aumann, Vincent Ninane, Geert M Verleden, Thierry Troosters, Kris Bogaerts, Guy G Brusselle, Wim Janssens
BACKGROUND: Long-term use of macrolide antibiotics is effective to prevent exacerbations in chronic obstructive pulmonary disease (COPD). As risks and side effects of long-term intervention outweigh the benefits in the general COPD population, the optimal dose, duration of treatment, and target population are yet to be defined. Hospitalization for an acute exacerbation (AE) of COPD may offer a targeted risk group and an obvious risk period for studying macrolide interventions. METHODS/DESIGN: Patients with COPD, hospitalized for an AE, who have a smoking history of ≥10 pack-years and had ≥1 exacerbation in the previous year will be enrolled in a multicenter, randomized, double-blind, placebo-controlled trial (NCT02135354)...
2016: International Journal of Chronic Obstructive Pulmonary Disease
M C Pietanza, Matthew D Hellmann, John J Fiore, Stephanie Smith-Marrone, Ethan M Basch, Lawrence H Schwartz, Michelle S Ginsberg, Marwan Shouery, Samantha K Newman, Mary Shaw, Lauren J Rogak, Alex E Lash, Patrick Hilden, Mark G Kris
INTRODUCTION: Many patients with lung cancers cannot receive platinum-containing regimens owing to comorbid medical conditions. We designed the PPB (paclitaxel, pemetrexed, and bevacizumab) regimen to maintain or improve outcomes while averting the unique toxicities of platinum-based chemotherapies. METHODS: We enrolled patients with untreated, advanced lung adenocarcinomas with measurable disease and no contraindications to bevacizumab. Participants received paclitaxel, 90 mg/m(2), pemetrexed, 500 mg/m(2), and bevacizumab, 10 mg/kg, every 14 days for 6 months and continued to receive pemetrexed and bevacizumab every 14 days until progression or unacceptable toxicity...
June 2016: Journal of Thoracic Oncology
Sofie Wilgenhof, Jurgen Corthals, Carlo Heirman, Nicolas van Baren, Sophie Lucas, Pia Kvistborg, Kris Thielemans, Bart Neyns
PURPOSE: Autologous monocyte-derived dendritic cells (DCs) electroporated with synthetic mRNA (TriMixDC-MEL) are immunogenic and have antitumor activity as a monotherapy in patients with pretreated advanced melanoma. Ipilimumab, an immunoglobulin G1 monoclonal antibody directed against the cytotoxic T-lymphocyte-associated protein 4 receptor that counteracts physiologic suppression of T-cell function, improves the overall survival of patients with advanced melanoma. This phase II study investigated the combination of TriMixDC-MEL and ipilimumab in patients with pretreated advanced melanoma...
April 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Maureen D Francis, Katherine A Julian, David A Wininger, Sean Drake, KeriLyn Bollman, Christopher Nabors, Anne Pereira, Michael Rosenblum, Amy B Zelenski, David Sweet, Kris Thomas, Andrew Varney, Eric Warm, Mark L Francis
BACKGROUND: Efforts to improve diabetes care in residency programs are ongoing and in the midst of continuity clinic redesign at many institutions. While there appears to be a link between resident continuity and improvement in glycemic control for diabetic patients, it is uncertain whether clinic structure affects quality measures and patient outcomes. METHODS: This multi-institutional, cross-sectional study included 12 internal medicine programs. Three outcomes (glycemic control, blood pressure control, and achievement of target low-density lipoprotein [LDL]) and 2 process measures (A1C and LDL measurement) were reported for diabetic patients...
February 2016: Journal of Graduate Medical Education
Cole Vonder Haar, Todd C Peterson, Kris M Martens, Michael R Hoane
With the numerous failures of pharmaceuticals to treat traumatic brain injury in humans, more researchers have become interested in combination therapies. This is largely due to the multimodal nature of damage from injury, which causes excitotoxicity, oxidative stress, edema, neuroinflammation and cell death. Polydrug treatments have the potential to target multiple aspects of the secondary injury cascade, while many previous therapies focused on one particular aspect. Of specific note are vitamins, minerals and nutrients that can be utilized to supplement other therapies...
June 1, 2016: Brain Research
Paul J Hesketh, Kari Bohlke, Gary H Lyman, Ethan Basch, Maurice Chesney, Rebecca Anne Clark-Snow, Michael A Danso, Karin Jordan, Mark R Somerfield, Mark G Kris
PURPOSE: To update a key recommendation of the American Society of Clinical Oncology antiemetic guideline. This update addresses the use of the oral combination of netupitant (a neurokinin 1 [NK1] receptor antagonist) and palonosetron (a 5-hydroxytryptamine-3 [5-HT3] receptor antagonist) for the prevention of acute and delayed nausea and vomiting in patients receiving chemotherapy. METHODS: An update committee conducted a targeted systematic literature review and identified two phase III clinical trials and a randomized phase II dose-ranging study...
February 1, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Marjan de Vries, Dagmar C M Van Rijckevorsel, Kris C P Vissers, Oliver H G Wilder-Smith, Harry Van Goor
AIM: We aimed to assess the analgesic efficacy, pharmacokinetics, tolerability and safety of a single dose of Δ9-THC in patients with chronic abdominal pain resulting from chronic pancreatitis (CP). METHODS: This was a randomized, single dose, double-blinded, placebo-controlled, two way crossover study in patients suffering from abdominal pain as result of CP (n = 24), post hoc subdivided into opioid and non-opioid users. Δ9-THC (8 mg) or active placebo (5 mg/10 mg diazepam) was administered orally in a double dummy design...
March 2016: British Journal of Clinical Pharmacology
Christine R Stehman, Takuhiro Moromizato, Caitlin K McKane, Kris M Mogensen, Fiona K Gibbons, Kenneth B Christopher
OBJECTIVE: In animal models of renal, intestinal, liver, cardiac, and cerebral ischemia, alcohol exposure is shown to reduce ischemia-reperfusion injury. Inpatient mortality of trauma patients is shown to be decreased in a dose-dependent fashion relative to blood alcohol concentration (BAC) at hospital admission. In this study, we examined the association between BAC at hospital admission and risk of 30-day mortality in critically ill patients. DESIGN: We performed a 2-center observational study of patients treated in medical and surgical intensive care units in Boston, Massachusetts...
December 2015: Journal of Critical Care
Anna S Jan, Dawn E Dolan, Kris Lombardi, Shilpa Gupta
BACKGROUND: Gemcitabine plus cisplatin is the standard of care for metastatic urothelial cancer and is frequently used in the neoadjuvant and adjuvant setting as well. However, the optimal dose and schedule for patients aged ≥ 65 years is not clear. PATIENTS AND METHODS: We performed a retrospective study to determine the tolerability of gemcitabine plus cisplatin for treatment of urothelial cancer in the elderly population. A total of 28 patients aged ≥ 65 years with urothelial cancer treated with gemcitabine plus cisplatin on a 21-day schedule from January 1, 2008 to August 31, 2013 were included in the present study...
June 2016: Clinical Genitourinary Cancer
Richard S Legro, William C Dodson, Penny M Kris-Etherton, Allen R Kunselman, Christy M Stetter, Nancy I Williams, Carol L Gnatuk, Stephanie J Estes, Jennifer Fleming, Kelly C Allison, David B Sarwer, Christos Coutifaris, Anuja Dokras
CONTEXT: Lifestyle modification is recommended in women with polycystic ovary syndrome (PCOS) prior to conception but there are few randomized trials to support its implementation or benefit. OBJECTIVE: This study aimed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS. DESIGN, SETTING, AND PARTICIPANTS: This was a randomized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS, age 18-40 y and body mass index 27-42 kg/m(2)...
November 2015: Journal of Clinical Endocrinology and Metabolism
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