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“Patient safety”

Masahiro Hosogai, Toshinori Matsushige, Koji Shimonaga, Tomohiro Kawasumi, Kaoru Kurisu, Shigeyuki Sakamoto
BACKGROUND: and Purpose: The optimal treatment strategy for ruptured intracranial dissecting aneurysms involving essential vessels remains controversial. The aim of this study was to review the safety and efficacy of endovascular treatment at our center. MATERIALS AND METHODS: A total of 11 ruptured intracranial dissecting aneurysms involving branching arteries or arising from a major intracranial vessel without tolerance of parental artery occlusion were treated consecutively using endovascular techniques from January 2013 through December 2017...
August 8, 2018: World Neurosurgery
Sandhya R Panch, Thejaswi Bikkani, Vanessa Vargas, Jolynn Procter, James W Atkins, Virginia Guptill, Karen M Frank, Anna F Lau, David F Stroncek
BACKGROUND: Product safety assurance is crucial for the clinical use of manufactured cellular therapies. A rational approach for delivering products which fail release criteria (due to potentially false-positive sterility results) is important to avoid unwarranted wastage of highly personalized and costly therapies in critically ill patients where benefits may outweigh risk. Accurate and timely interpretation of microbial sterility assays represents a major challenge in cell therapies...
August 8, 2018: Biology of Blood and Marrow Transplantation
Kang Jun Cho, Jeong Zoo Lee, Yun Seob Song, Jong Bo Choi, Dae Kyung Kim, Yong Tae Kim, Joon Chul Kim
OBJECTIVE: To evaluate the efficacy and safety of silodosin on nocturia in patients with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: This was a 12-week, single-arm, open-label, prospective, multicenter study. The study included men 50 years or older with nocturia (≥2 events/night) based on a voiding diary, an International Prostate Symptom Score (IPSS) ≥8, and a quality of life score ≥3. Enrolled patients received 8 mg of silodosin once daily for 12 weeks...
August 8, 2018: Urology
Matthew C L Phillips, Deborah K J Murtagh, Linda J Gilbertson, Fredrik J S Asztely, Christopher D P Lynch
BACKGROUND: Preliminary evidence suggests that diet manipulation may influence motor and nonmotor symptoms in PD, but conflict exists regarding the ideal fat to carbohydrate ratio. OBJECTIVES: We designed a pilot randomized, controlled trial to compare the plausibility, safety, and efficacy of a low-fat, high-carbohydrate diet versus a ketogenic diet in a hospital clinic of PD patients. METHODS: We developed a protocol to support PD patients in a diet study and randomly assigned patients to a low-fat or ketogenic diet...
August 11, 2018: Movement Disorders: Official Journal of the Movement Disorder Society
Baohui Han, Kai Li, Qiming Wang, Li Zhang, Jianhua Shi, Zhehai Wang, Ying Cheng, Jianxing He, Yuankai Shi, Yizhuo Zhao, Hao Yu, Yang Zhao, Weiqiang Chen, Yi Luo, Lin Wu, Xiuwen Wang, Robert Pirker, Kejun Nan, Faguang Jin, Jian Dong, Baolan Li, Yan Sun
Importance: Anlotinib is a novel multitarget tyrosine kinase inhibitor for tumor angiogenesis and proliferative signaling. A phase 2 trial showed anlotinib to improve progression-free survival with a potential benefit of overall survival, leading to the phase 3 trial to confirm the drug's efficacy in advanced non-small cell lung cancer (NSCLC). Objective: To investigate the efficacy of anlotinib on overall survival of patients with advanced NSCLC progressing after second-line or further treatment...
August 9, 2018: JAMA Oncology
K-A Dawn Lim, Hwei Wuen Chan, Ce Zheng, Maria C Aquino, Robert Ritch, Paul Tk Chew
IMPORTANCE: Argon laser peripheral iridoplasty (ALPI) could be effective in widening residual angle closure following laser peripheral iridotomy (LPI). BACKGROUND: We investigated changes in angle parameters following ALPI and its safety profile in this study. DESIGN: Retrospective, observational case series. PARTICIPANTS: The records from a single center, of 36 patients (60 eyes) who underwent ALPI, for residual angle closure following LPI, were reviewed...
August 11, 2018: Clinical & Experimental Ophthalmology
J Carles, A Pichler, H Korunkova, A Tomova, M Ghosn, F El Karak, J Makdessi, I Koroleva, G Barnes, D Bury, A Özatilgan, S Hitier, J Katolicka
OBJECTIVES: To obtain routine clinical practice data on cabazitaxel usage patterns for patients with metastatic castration-resistant prostate cancer (mCRPC) and to describe physician-assessed cabazitaxel effectiveness, health-related quality of life (HRQL) and safety. PATIENTS AND METHODS: CAPRISTANA was an international, observational cohort study examining cabazitaxel use for the treatment of patients with mCRPC. Effectiveness was assessed by overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF) and disease control rate...
August 11, 2018: BJU International
François Montastruc, Justine Benevent, Vanessa Rousseau, Geneviève Durrieu, Agnès Sommet, Jean-Louis Montastruc
In contrast to statins, the risk of diabetes with fibrates was not clearly studied. The present study investigates a putative signal of diabetes associated with the use of fibrates using the World Health Organization (WHO) global individual case safety reports database, VigiBase® . We included all reports registered until the 31st December 2017 in VigiBase® to measure the risk of reporting "hyperglycemia or new onset of diabetes" (SMQ term) compared with all other reports [as a Reporting Odds Ratio (ROR 95%CI)] for fibrates, statins and the combination fibrates + statins...
August 11, 2018: Fundamental & Clinical Pharmacology
Min-Ho Shin, Gi-Won Song, Sung-Gyu Lee, Shin Hwang, Ki-Hun Kim, Chul-Soo Ahn, Deok-Bog Moon, Tae-Yong Ha, Dong-Hwan Jung, Gil-Chun Park, Young-In Yun, Wan-Jun Kim, Woo-Hyoung Kang, Seok-Hwan Kim, Hongsi Jiang, Sungmin Lee, Eun-Young Tak
Randomized, open-label, comparative, single-center, Phase 4, 24-week study comparing pharmacokinetics (PK), safety, and efficacy of once-daily, prolonged-release tacrolimus (PR-T) with twice-daily, immediate-release tacrolimus (IR-T) in adult de novo living-donor liver transplant (LDLT) recipients in Korea. All patients received intravenous tacrolimus from Day 0 (transplantation) for 4 days and were randomized (1:1) to receive oral PR-T or IR-T from Day 5. PK profiles taken on Days 6 and 21. Primary endpoint: area-under-the-concentration-time curve over 24h (AUC0-24 )...
August 11, 2018: Clinical Transplantation
Otavio Berwanger, Magdy Abdelhamid, Thomas Alexander, Abdulmajeed Alzubaidi, Oleg Averkov, Philip Aylward, Eduardo Contreras Zúñiga, Sigrun Halvorsen, Ricardo Iglesias, Muhamad A Sk Abdul Kader, Mohammad Zubaid, Khalid F AlHabib
Primary percutaneous coronary intervention (PCI) is the preferred reperfusion method in patients with ST-segment elevation myocardial infarction (STEMI). In patients with STEMI who cannot undergo timely primary PCI, pharmacoinvasive treatment is recommended, comprising immediate fibrinolytic therapy with subsequent coronary angiography and rescue PCI if needed. Improving clinical outcomes following fibrinolysis remains of great importance for the many patients globally for whom rapid treatment with primary PCI is not possible...
August 11, 2018: Clinical Cardiology
Renée Dagenais, Peter J Zed
Intranasal lidocaine has been studied and recommended as an alternative in the management of acute headache. The objective of this systematic review was to evaluate the efficacy and safety of intranasal lidocaine in the acute management of primary headaches. The MEDLINE (1946 to May 2018), EMBASE (1974 to May 2018), Cochrane Central Register of Controlled Trials (2008 to May 2018), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to May 2018), and ClincialTrials. gov online databases were searched...
August 11, 2018: Pharmacotherapy
Sharon Samueli, Anastasia Dressler, Gudrun Gröppel, Theresa Scholl, Martha Feucht
Tuberous sclerosis complex (TSC) is the most common cause of West syndrome (WS). Currently available treatment options are ineffective in the majority of affected infants and/or associated with potential serious side effects. Based on the assumption that mTOR overactivation results in increased neuroexcitability in TSC, mTOR inhibitors have been studied as antiseizure therapy. As a result, everolimus recently received approval for the adjunctive treatment of patients aged ≥2 years with refractory TSC-associated focal and secondary generalized seizures...
August 10, 2018: Epilepsia
Paras P Vakharia, Rishi Chopra, Nanette B Silverberg, Jonathan I Silverberg
BACKGROUND AND OBJECTIVE: Topical cantharidin is routinely used for the treatment of molluscum contagiosum and warts. The objective of this systematic review is to assess the efficacy and safety of topical cantharidin treatment for molluscum contagiosum and warts. METHODS: We performed a systematic review of studies assessing topical cantharidin treatment of molluscum contagiosum or warts. We searched the databases of Cochrane, EMBASE, GREAT, LILACS, MEDLINE, and Scopus...
August 10, 2018: American Journal of Clinical Dermatology
J F Willms, O Boss, E Keller
BACKGROUND: Fever control plays a key role in therapy of patients with acute brain injury. The infusion of cold saline could serve as an alternative or additional method for targeted temperature management. However, it is difficult to estimate the amount of fluid required to achieve normothermia merely on the basis of body weight. There is no standardized load management regarding the administration of cold saline, and no closed-loop systems based on continuous temperature-controlled feedback are available...
August 10, 2018: Neurocritical Care
Matteo Gregori, Diletta Cassini, Norma Depalma, Michelangelo Miccini, Farshad Manoochehri, Gianandrea A Baldazzi
The surgical treatment for patients with generalized peritonitis complicating sigmoid diverticulitis is currently debated; particularly in case of diffuse purulent contamination (Hinchey 3). Laparoscopic lavage and drainage (LLD) has been proposed by some authors as a safe and effective alternative to single- or multi-stage resective surgery. However, among all the different studies on LLD, there is no uniformity in terms of surgical technique adopted and data show significant differences in postoperative outcomes...
August 10, 2018: Updates in Surgery
Ryan Morgan, Michael Cassidy, Susanna W L DeGeus, Jennifer Tseng, David McAneny, Teviah Sachs
INTRODUCTION: Gastric cancer is decreasing nationally but remains pervasive globally. We evaluated our experience with gastric cancer at a safety-net hospital with a substantial immigrant population. METHODS: Demographics, pathology, and treatment were analyzed for gastric adenocarcinoma at our institution (2004-2017). Chi-square analyses were performed for dependence of staging on demographics. Survival was evaluated with Kaplan-Meier and Cox regression analyses...
August 10, 2018: Journal of Gastrointestinal Surgery: Official Journal of the Society for Surgery of the Alimentary Tract
Henry J Woodford
Urinary incontinence (UI) is a common and disabling problem among older people. Anticholinergic drugs (ADs) are a pharmacological option recommended for overactive bladder or mixed UI when non-pharmacological approaches have failed. However, UI is a more prevalent and complex condition in frail older people and to simply assume that AD actions are the same across all age groups would be wrong. This article reviews evidence for the efficacy and safety of these drugs, especially when prescribed for frail older people...
August 10, 2018: Drugs & Aging
Émilie Proulx, Audrey Auclair, Marie-Eve Piché, Jany Harvey, Myriam Pettigrew, Laurent Biertho, Simon Marceau, Paul Poirier
INTRODUCTION: Safety of exercise training in relationship with the risk of hypoglycemia post-bariatric surgery is unknown. OBJECTIVE: To evaluate the safety and magnitude of changes in blood glucose levels during exercise training following bariatric surgery. MATERIAL AND METHODS: Twenty-nine severely obese patients undergoing either sleeve gastrectomy (SG) (n = 16) or biliopancreatic diversion with duodenal switch (BPD-DS) (n = 13) were prospectively enrolled...
August 10, 2018: Obesity Surgery
Samuel W D Merriel, Garth Funston, Willie Hamilton
Prostate cancer is a common malignancy seen worldwide. The incidence has risen in recent decades, mainly fuelled by more widespread use of prostate-specific antigen (PSA) testing, although prostate cancer mortality rates have remained relatively static over that time period. A man's risk of prostate cancer is affected by his age and family history of the disease. Men with prostate cancer generally present symptomatically in primary care settings, although some diagnoses are made in asymptomatic men undergoing opportunistic PSA screening...
August 10, 2018: Advances in Therapy
Aabha Nagral, Ajay Jhaveri, Smita Sawant, Nirzar Samir Parikh, Nishtha Nagral, Rashid Merchant, Mihir Gandhi
OBJECTIVES: To assess the efficacy and safety of sofosbuvir based generic Direct Acting Antivirals (DAAs) in treatment of Hepatitis C virus (HCV) in adolescents with thalassemia major (TM). METHODS: In this prospective single-arm study, 18 TM adolescents with Chronic Hepatitis C received sofosbuvir based generic DAAs. Patients with genotype 1 and genotype 3 received ledipasvir and daclatasvir respectively. Two cirrhotic patients with genotype 3 also received ribavirin...
August 10, 2018: Indian Journal of Pediatrics
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