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https://www.readbyqxmd.com/read/28637246/effect-of-psilocybin-on-empathy-and-moral-decision-making
#1
Thomas Pokorny, Katrin H Preller, Michael Kometer, Isabel Dziobek, Franz X Vollenweider
Background: Impaired empathic abilities lead to severe negative social consequences and influence the development and treatment of several psychiatric disorders. Furthermore, empathy has been shown to play a crucial role in moral and prosocial behaviour. Although the serotonin (5-HT) system has been implicated in modulating empathy and moral behaviour, the relative contribution of the various 5-HT receptor subtypes is still unknown. Methods: We investigated the acute effect of psilocybin (0...
June 16, 2017: International Journal of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28637064/safety-and-efficacy-of-glycopyrrolate-as-a-premedication-for-endoscopic-submucosal-dissection-a-randomized-double-blind-placebo-controlled-study
#2
Eui Joo Kim, Min Young Um, Kyoung Oh Kim, Jung Ho Kim, Su Young Kim, Dong Kyun Park, Kwang An Kwon, Jun Won Chung, Yoon Jae Kim
Background and study aims Anticholinergic premedication has not been validated for endoscopic submucosal dissection (ESD). In this randomized, double-blind, placebo-controlled trial, we investigated the efficacy and safety of glycopyrrolate as a premedication for ESD. Methods A total of 196 patients undergoing ESD at a single tertiary medical center between December 2014 and February 2016 were randomly allocated to receive one of the following two premedications: glycopyrrolate (0.004 mg/kg intramuscularly [IM]) or placebo (2...
June 21, 2017: Endoscopy
https://www.readbyqxmd.com/read/28637032/investigation-of-an-immediate-effect-of-bright-light-on-oxygen-consumption-heart-rate-cortisol-and-%C3%AE-amylase-in-seasonal-affective-disorder-subjects-and-healthy-controls
#3
Iana A Ivanova, Konstantin V Danilenko, Lyubomir I Aftanas
BACKGROUND: Body (fat) mass has been shown to decrease following bright light treatment for overweight women, irrespective of their seasonal (light) dependence. It is not known if this is due to an (immediate) increase of metabolism. METHODS: Ten women with seasonal affective disorder (SAD) and 10 non-SAD women matched by age, body mass index, and menopausal status participated in a laboratory study in the morning, twice within 1-5 days. During one session, bright light (4,300 lx) was presented for 30 min, and during the other session, red light (250 lx "placebo") was used...
June 22, 2017: Neuropsychobiology
https://www.readbyqxmd.com/read/28636828/pharmacokinetic-drug-evaluation-of-extended-release-lorcaserin-for-the-treatment-of-obesity
#4
Kathryn Hurren, Marissa W Dunham
Lorcaserin is a serotonin 2C receptor antagonist that was FDA approved in 2012. Lorcaserin is recently available as an extended-release (ER) formulation for the treatment of obesity as an adjunct to lifestyle modification. Areas covered: The pharmacokinetics, pharmacodynamics, efficacy, and safety of lorcaserin ER will be reviewed. Expert opinion: Lorcaserin ER 20mg daily provides drug exposure bioequivalent to lorcaserin immediate release (IR) 10mg twice daily. Lorcaserin IR is associated with 3.3% and 3.0% placebo-subtracted weight loss in patients without and with diabetes, respectively...
June 21, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28636754/linagliptin-and-its-effects-on-hyperglycaemia-and-albuminuria-in-patients-with-type-2-diabetes-and-renal-dysfunction-the-randomized-marlina-t2d%C3%A2-trial
#5
P-H Groop, M E Cooper, V Perkovic, B Hocher, K Kanasaki, M Haneda, G Schernthaner, K Sharma, R C Stanton, R Toto, J Cescutti, M Gordat, T Meinicke, A Koitka-Weber, S Thiemann, M von Eynatten
AIMS: The MARLINA-T2D™ study (ClinicalTrials.gov, NCT01792518) was designed to investigate the glycaemic and renal effects of linagliptin added to standard-of-care in individuals with type 2 diabetes and albuminuria. METHODS: 360 individuals with type 2 diabetes, HbA1c 6.5 - 10.0% (48 - 86 mmol/mol), estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m(2) , and urinary albumin-to-creatinine ratio (UACR) 30-3000 mg/g despite single agent renin-angiotensin-system blockade were randomized to double-blind linagliptin (n = 182) or placebo (n = 178) for 24 weeks...
June 21, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28636752/comparison-of-effect-sizes-between-enriched-and-non-enriched-trials-of-analgesics-for-chronic-musculoskeletal-pain-a-systematic-review
#6
Tie P Yamato, Chris G Maher, Bruno T Saragiotto, Christina Abdel Shaheed, Anne M Moseley, Chung-Wei Christine Lin, Bart Koes, Andrew J McLachlan
OBJECTIVE: To investigate the use of an enriched study design on the estimates of treatment effect in analgesic trials for chronic musculoskeletal pain METHODS: Database searches were conducted from 2004 to 2014. We included randomised placebo-controlled trials evaluating pain medications for chronic musculoskeletal pain. Methodological quality was assessed using the PEDro scale. The estimates of treatment effect on pain and adverse events were compared between enriched and non-enriched designs...
June 21, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28636694/placebo-response-and-practice-effects-in-schizophrenia-cognition-trials
#7
Richard S E Keefe, Vicki G Davis, Philip D Harvey, Alexandra S Atkins, George M Haig, Owen Hagino, Stephen Marder, Dana C Hilt, Daniel Umbricht
Importance: Patients' previous experience with performance-based cognitive tests in clinical trials for cognitive impairment associated with schizophrenia can create practice-related improvements. Placebo-controlled trials for cognitive impairment associated with schizophrenia are at risk for these practice effects, which can be difficult to distinguish from placebo effects. Objectives: To conduct a systematic evaluation of the magnitude of practice effects on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) in cognitive impairment associated with schizophrenia and to examine which demographic, clinical, and cognitive characteristics were associated with improvement in placebo conditions...
June 21, 2017: JAMA Psychiatry
https://www.readbyqxmd.com/read/28636648/cost-effectiveness-of-pazopanib-versus-sunitinib-for-metastatic-renal-cell-carcinoma-in-the-united-kingdom
#8
Jordan Amdahl, Jose Diaz, Arati Sharma, Jinhee Park, David Chandiwana, Thomas E Delea
BACKGROUND: Sunitinib and pazopanib are the only two targeted therapies for the first-line treatment of locally advanced or metastatic renal cell carcinoma (mRCC) recommended by the United Kingdom's National Institute for Health and Care Excellence. Pazopanib demonstrated non-inferior efficacy and a differentiated safety profile versus sunitinib in the phase III COMPARZ trial. The current analysis provides a direct comparison of the cost-effectiveness of pazopanib versus sunitinib from the perspective of the United Kingdom's National Health Service based on data from COMPARZ and other sources...
2017: PloS One
https://www.readbyqxmd.com/read/28636208/a-phase-i-trial-of-prn1008-a-novel-reversible-covalent-inhibitor-of-bruton-s-tyrosine-kinase-in-healthy-volunteers
#9
Patrick F Smith, Janakan Krishnarajah, Philip A Nunn, Ron J Hill, Dane Karr, D Tam, Mohammad Masjedizadeh, Jens O Funk, Steve G Gourlay
AIM: To evaluate the safety, tolerability, and PK/PD of PRN1008, a novel BTK inhibitor, in healthy volunteers, and thus determine the dose range for future clinical studies. METHODS: This was a two-part randomized, placebo controlled study in healthy volunteers using a liquid formulation. Part I was a single ascending dose design with dose levels of 50 to 1200 mg (n=6 active, 2 placebo per cohort); Part II was a multiple ascending dose design, with dose regimens ranging from 300 mg to 900 mg daily, either qd or bd for 10 days...
June 21, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28635634/despite-inflammation-supplemented-essential-amino-acids-may-improve-circulating-levels-of-albumin-and-haemoglobin-in-patients-after-hip-fractures
#10
Roberto Aquilani, Ginetto Carlo Zuccarelli, Anna Maria Condino, Michele Catani, Carla Rutili, Consiglia Del Vecchio, Pietro Pisano, Manuela Verri, Paolo Iadarola, Simona Viglio, Federica Boschi
Essential amino acids (EAAs) are nutritional substrates that promote body protein synthesis; thus we hypothesised that their supplementation may improve circulating albumin (Alb) and haemoglobin (Hb) in rehabilitative elderly patients following hip fractures (HF). Out of the 145 HF patients originally enrolled in our study, 112 completed the protocol. These subjects were divided into two randomised groups, each containing 56 patients. For a period of two months, one group (age 81.4 ± 8.1 years; male/female 27/29) received a placebo, and the other (age 83...
June 21, 2017: Nutrients
https://www.readbyqxmd.com/read/28635331/network-meta-analysis-of-liraglutide-versus-dpp-4-inhibitors-for-the-treatment-of-type-2-diabetes-in-japanese-patients
#11
Dieter Ayers, Steve Kanters, Rachel Goldgrub, Monica Hughes, Ryo Kato, Nana Kragh
AIMS: To determine the comparative efficacy and safety of liraglutide and dipeptidyl peptidiase-4 (DPP-4) inhibitors as antidiabetics for Japanese patients with uncontrolled type 2 diabetes (T2DM). METHODS AND MATERIALS: We searched for randomized-controlled trials (RCTs) evaluating outcomes among Japanese adults with uncontrolled T2DM and including liraglutide or DPP-4 inhibitors up to August 2016. We extracted data on trial and patient characteristics, and the following outcomes: HbA1c, weight, patients meeting HbA1c <7%, patients experiencing hypoglycemic events, microalbuminuria, estimated glomerular filtration rate (eGFR) and creatinine...
June 21, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28635182/the-effect-of-flaxseed-supplementation-on-body-weight-and-body-composition-a-systematic-review-and-meta-analysis-of-45-randomized-placebo-controlled-trials
#12
REVIEW
M Mohammadi-Sartang, Z Mazloom, H Raeisi-Dehkordi, R Barati-Boldaji, N Bellissimo, J O Totosy de Zepetnek
Flaxseed consumption may be inversely associated with obesity; however, findings of available randomized controlled trials (RCTs) are conflicting. The present study aimed to systematically review and analyse RCTs assessing the effects of flaxseed consumption on body weight and body composition. PubMed, Medline via Ovid, SCOPUS, EMBASE and ISI Web of Sciences databases were searched up to November 2016. Mean changes in body composition indices including body weight, body mass index (BMI) and waist circumference were extracted...
June 21, 2017: Obesity Reviews: An Official Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/28635153/topical-silymarin-administration-for-prevention-of-capecitabine-induced-hand-foot-syndrome-a-randomized-double-blinded-placebo-controlled-clinical-trial
#13
Sepideh Elyasi, Farzaneh Sadat Rezazadeh Shojaee, Abolghasem Allahyari, Gholamreza Karimi
Hand-foot syndrome (HFS) is a frequent dose-limiting adverse reaction of capecitabine in patient with gastrointestinal cancers. Silymarin is a polyphenolic flavonoid extracted from the Silybum marianum that exhibits strong antioxidant and antiinflammatory activities. In this study, we evaluated silymarin efficacy in prevention of capecitabine-induced HFS in patients with gastrointestinal cancers, as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of silymarin gel 1%, which is applied on the palms and soles twice daily starting at the first day of chemotherapy for 9 weeks, on HFS occurrence was assessed...
June 21, 2017: Phytotherapy Research: PTR
https://www.readbyqxmd.com/read/28634748/exposure-response-relationship-of-ramucirumab-in-east-asian-patients-from-rainbow-a-randomized-clinical-trial-in-second-line-treatment-of-gastric-cancer
#14
Tae You Kim, Chia-Jui Yen, Salah-Eddin Al-Batran, David Ferry, Ling Gao, Yanzhi Hsu, Rebecca Cheng, Mauro Orlando, Atsushi Ohtsu
BACKGROUND: Ramucirumab is a recombinant human IgG1 neutralizing monoclonal antibody specific for vascular endothelial growth factor receptor-2. Second-line ramucirumab, in conjunction with paclitaxel (ramucirumab 8 mg/kg or placebo in combination with 80 mg/m(2) paclitaxel), has been shown to be effective and safe in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in RAINBOW, a global phase III randomized clinical trial. We conducted an exploratory exposure-response analysis of efficacy and safety of ramucirumab in East Asian patients from the RAINBOW trial...
June 20, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28634654/improvement-in-latent-variable-indirect-response-modeling-of-multiple-categorical-clinical-endpoints-application-to-modeling-of-guselkumab-treatment-effects-in-psoriatic-patients
#15
Chuanpu Hu, Bruce Randazzo, Amarnath Sharma, Honghui Zhou
Exposure-response modeling plays an important role in optimizing dose and dosing regimens during clinical drug development. The modeling of multiple endpoints is made possible in part by recent progress in latent variable indirect response (IDR) modeling for ordered categorical endpoints. This manuscript aims to investigate the level of improvement achievable by jointly modeling two such endpoints in the latent variable IDR modeling framework through the sharing of model parameters. This is illustrated with an application to the exposure-response of guselkumab, a human IgG1 monoclonal antibody in clinical development that blocks IL-23...
June 20, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28634650/a-randomized-phase-ii-study-of-gemcitabine-plus-z-360-a-cck2-receptor-selective-antagonist-in-patients-with-metastatic-pancreatic-cancer-as-compared-with-gemcitabine-plus-placebo
#16
Makoto Ueno, Chung Pin Li, Masafumi Ikeda, Hiroshi Ishii, Nobumasa Mizuno, Taketo Yamaguchi, Tatsuya Ioka, Do Youn Oh, Wataru Ichikawa, Takuji Okusaka, Yutaka Matsuyama, Daichi Arai, Li Tzong Chen, Young Suk Park, Junji Furuse
BACKGROUND: We investigated the efficacy and safety of 60, 120, or 240 mg of Z-360, which is a highly potent cholecystokinin2-receptor-selective antagonist, combined with gemcitabine in patients with metastatic pancreatic cancer. METHODS: Patients were randomly assigned in a 1:1:1:1 ratio to one of four treatment groups. Patients received 1000 mg/m(2) gemcitabine for each cycle and Z-360 tablets of 60 mg (GZ 60 mg group), 120, 240 mg or placebo tablets (Gem group) orally twice daily...
June 20, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28634219/early-use-of-n-acetylcysteine-nac-with-nitrate-therapy-in-patients-undergoing-primary-percutaneous-coronary-intervention-for-st-segment-elevation-myocardial-infarction-reduces-myocardial-infarct-size-the-naciam-trial
#17
Sivabaskari Pasupathy, Rosanna Tavella, Suchi Grover, Betty Raman, Nathan E K Procter, Yang T Du, Gnanadevan Mahadavan, Irene Stafford, Tamila Heresztyn, Andrew Holmes, Christopher Zeitz, Margaret Arstall, Joseph B Selvanayagam, John D Horowitz, John F Beltrame
Background -Contemporary ST-elevation myocardial infarction (STEMI) management involves primary percutaneous coronary intervention (PCI) with on-going studies focusing on infarct size reduction utilizing ancillary therapies. N-acetylcysteine (NAC) is an antioxidant with reactive oxygen species scavenging properties that also potentiates the effects of nitroglycerin (NTG) and thus represents a potentially beneficial ancillary therapy in primary PCI. The NACIAM (NACIn Acute Myocardial infarction) trial examined the effects of NAC on infarct size in STEMI patients undergoing PCI...
June 20, 2017: Circulation
https://www.readbyqxmd.com/read/28634136/tongxie-formula-reduces-symptoms-of-irritable-bowel-syndrome
#18
Heng Fan, Liang Zheng, Yaoliang Lai, Weimin Lu, Zhixiang Yan, Qi Xiao, Baiwen Li, Min Tang, Dawei Huang, Yuanyuan Wang, Zhen Li, Yuwei Mei, Zhengyan Jiang, Xingxing Liu, Qing Tang, Dongmei Zuo, Jingyi Ye, Yongqiang Yang, Huisuo Huang, Zongxiang Tang, Jun Xiao
BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is the most common chronic gastrointestinal disorder, yet few drugs are effective in reducing symptoms. Approximately 50% of patients with IBS attempt herbal therapy at least once. We performed a randomized controlled trial to compare the efficacy of the herb formulation tongxie vs placebo or pinaverium (an antispasmodic agent) in reducing symptoms of IBS. METHODS: We performed a trial of 1044 adult patients with IBS (based on Rome III criteria) at 5 hospitals in China, from August 2012 through January 2015...
June 17, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28634037/clinical-benefit-of-drugs-targeting-mitochondrial-function-as-an-adjunct-to-reperfusion-in-st-segment-elevation-myocardial-infarction-a-meta-analysis-of-randomized-clinical-trials
#19
Gianluca Campo, Rita Pavasini, Giampaolo Morciano, A Michael Lincoff, C Michael Gibson, Masafumi Kitakaze, Jacob Lonborg, Amrita Ahluwalia, Hideki Ishii, Michael Frenneaux, Michel Ovize, Marcello Galvani, Dan Atar, Borja Ibanez, Giampaolo Cerisano, Simone Biscaglia, Brandon J Neil, Masanori Asakura, Thomas Engstrom, Daniel A Jones, Dana Dawson, Roberto Ferrari, Paolo Pinton, Filippo Ottani
AIMS: To perform a systematic review and meta-analysis of randomized clinical trials (RCT) comparing the effectiveness of drugs targeting mitochondrial function vs. placebo in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical coronary reperfusion. METHODS: Inclusion criteria: RCTs enrolling STEMI patients treated with primary percutaneous coronary intervention (PCI) and comparing drugs targeting mitochondrial function vs. placebo...
June 13, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28634000/dose-dependent-effects-of-abobotulinumtoxina-dysport%C3%A2-on-spasticity-and-active-movements-in-adults-with-upper-limb-spasticity-secondary-analysis-of-a-phase-3-study
#20
Michael W O'Dell, Allison Brashear, Robert Jech, Thierry Lejeune, Philippe Marque, Djamel Bensmail, Ziyad Ayyoub, David M Simpson, Magali Volteau, Claire Vilain, Philippe Picaut, Jean Michel Gracies
BACKGROUND: AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited. OBJECTIVE: To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS. DESIGN: Secondary analysis of a phase 3 study (NCT01313299). SETTING: Multi-center, international, double-blind, placebo-controlled clinical trial...
June 17, 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
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