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Jay Panchal, Gerard Malanga, Mitchell Sheinkop
The aim of this study was to evaluate the safety and efficacy of using autologous, micro-fractured, minimally manipulated adipose tissue in patients with refractory knee osteoarthritis (OA). A total of 17 subjects (26 knees) with a median age of 72 years (range: 54-78 years) and a history of knee OA (Kellgren-Lawrence, grade of 3 or 4) underwent treatment with ultrasound-guided injection of micro-fractured adipose tissue. Micro-fractured fat was obtained using a minimal manipulation technique in a closed system (Lipogems), without the addition of enzymes or any other additives...
November 2018: American Journal of Orthopedics
V Gavrysyuk, E Merenkova, G Gumeniuk, M Gumeniuk, Y Dziublyk
Immunosuppressants are traditionally administered in sarcoidosis patients with contraindications for the use of glucocorticosteroids (GCS), or in those with serious adverse reactions on GCS, as well as in the cases of GCS-therapy resistance. Aim - to study the effectiveness and safety of methotrexate monotherapy in pulmonary sarcoidosis patients with either GCS contraindication or adverse reactions. We examined 33 patients with st. II pulmonary sarcoidosis, 20 men and 13 women, 23-67 years of age. In all cases a general physical examination; chest computed tomography and spirometry were performed...
October 2018: Georgian Medical News
Bart Hiemstra, Geert Koster, Jørn Wetterslev, Christian Gluud, Janus C Jakobsen, Thomas W L Scheeren, Frederik Keus, Iwan C C van der Horst
BACKGROUND: Dopamine has been used in patients with cardiac dysfunction for more than five decades. Yet, no systematic review has assessed the effects of dopamine in critically ill patients with cardiac dysfunction. METHODS: This systematic review was conducted following The Cochrane Handbook for Systematic Reviews of Interventions. We searched for trials including patients with observed cardiac dysfunction published until 19 April 2018. Risk of bias was evaluated and Trial Sequential Analyses were conducted...
December 4, 2018: Acta Anaesthesiologica Scandinavica
Victoria Pilkington, Andrew Hill, Sophie Hughes, Nneka Nwokolo, Anton Pozniak
Background: Tenofovir/emtricitabine (TDF/FTC) used as pre-exposure prophylaxis (PrEP) has proven benefits in preventing HIV infection. Widespread use of TDF/FTC can only be justified if the preventative benefits outweigh potential risks of adverse events. A previous meta-analysis of TDF/FTC compared to alternative tenofovir alafenamide (TAF)/FTC for treatment found no significant difference in safety endpoints when used without ritonavir or cobicistat, but more evidence around the safety of TDF/FTC is needed to address concerns and inform widespread use...
October 1, 2018: Journal of Virus Eradication
Huawei Chen, Hui Qian, Zhiwei Gu, Majun Wang
Whether or not paracetamol can improve functional outcomes in patients with acute stroke has been examined in several clinical trials. The inconsistent results of these trials have caused great controversy regarding the need for further studies. In the present meta-analysis, we have aimed to address this controversy. The main databases (Medline, Embase, and Cochrane Library) were searched for randomized controlled trials involving the use of paracetamol in acute stroke patients. Pooled relative risks (RRs) or mean differences (MDs) and 95% confidence intervals (CIs) were calculated using a random-effects model...
2018: Frontiers in Neurology
Guoliang Qiao, Xiao-Li Wang, Lei Zhou, Xin-Na Zhou, Yuguang Song, Shuo Wang, Lei Zhao, Michael A Morse, Amy Hobeika, Jin Song, Xin Yi, Xuefeng Xia, Jun Ren, Herbert Kim Lyerly
PURPOSE: We have assessed the combination of DC-CIK with S-1 plus cisplatin chemotherapy in advanced gastric cancer(AGC) and the role of mutational analysis of circulating tumor DNA(ctDNA) and T cell receptor (TCR) repertoire in predicting clinical outcomes. EXPERIMENTAL DESIGN: Consecutive patients (n=63) with advanced gastric cancer were allocated to treatment with S-1 alone, S-1 plus cisplatin, DC-CIK combined with S-1 or DC-CIK combined with S-1 plus cisplatin...
December 4, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Patawut Bovonratwet, Michael C Fu, Murillo Adrados, Nathaniel T Ondeck, Edwin P Su, Jonathan N Grauer
BACKGROUND: The incidence of periprosthetic hip fractures is increasing due to higher numbers of total hip arthroplasties being performed. Unlike native hip fractures, the effect of time to surgery of periprosthetic hip fractures is not well established. This study evaluates the effect of time to surgery on perioperative complications for patients with periprosthetic hip fractures. METHODS: Patients who underwent surgery for periprosthetic hip fracture were identified in the 2005-2016 National Surgical Quality Improvement Program database and stratified into 2 groups: <2 and ≥2 days from hospital admission to surgery...
November 12, 2018: Journal of Arthroplasty
Junaid Raja, Johannes M Ludwig, Scott N Gettinger, Kurt A Schalper, Hyun S Kim
BACKGROUND: Immunotherapy is at the forefront of modern oncologic care. Various novel therapies have targeted all three layers of tumor biology: tumor, niche, and immune system with a range of promising results. One emerging class in both primary and salvage therapy is oncolytic viruses. This therapy offers a multimodal approach to specifically and effectively target and destroy malignant cells, though a barrier oncoviral therapies have faced is a limited therapeutic response to currently delivery techniques...
December 4, 2018: Journal for Immunotherapy of Cancer
Kerstin Stähr, Anja Eckstein, Laura Holtmann, Anke Schlüter, Meaghan Dendy, Stephan Lang, Stefan Mattheis
INTRODUCTION: Different minimally invasive surgical approaches to the orbit allow individualized bone resection to reduce proptosis and decompress the optic nerve in patients with Graves' orbitopathy (GO). This study aims to compare piezosurgery to an oscillating saw used to resect bone from the lateral orbital wall. METHODS: In a retrospective study, we analyzed balanced orbital decompressions performed on 174 patients (318 cases) with GO. An oscillating saw was used in 165 cases (saw group) and piezosurgery in 153 cases (piezo group)...
December 4, 2018: Orbit
Cissy Kityo, Alexander J Szubert, Abraham Siika, Robert Heyderman, Mutsa Bwakura-Dangarembizi, Abbas Lugemwa, Shalton Mwaringa, Anna Griffiths, Immaculate Nkanya, Sheila Kabahenda, Simon Wachira, Godfrey Musoro, Chatu Rajapakse, Timothy Etyang, James Abach, Moira J Spyer, Priscilla Wavamunno, Linda Nyondo-Mipando, Ennie Chidziva, Kusum Nathoo, Nigel Klein, James Hakim, Diana M Gibb, A Sarah Walker, Sarah L Pett
BACKGROUND: In sub-Saharan Africa, individuals infected with HIV who are severely immunocompromised have high mortality (about 10%) shortly after starting antiretroviral therapy (ART). This group also has the greatest risk of morbidity and mortality associated with immune reconstitution inflammatory syndrome (IRIS), a paradoxical response to successful ART. Integrase inhibitors lead to significantly more rapid declines in HIV viral load (VL) than all other ART classes. We hypothesised that intensifying standard triple-drug ART with the integrase inhibitor, raltegravir, would reduce HIV VL faster and hence reduce early mortality, although this strategy could also risk more IRIS events...
December 2018: PLoS Medicine
Stephen M Schmitz, Hector L Lopez, Douglas Mackay, Haiuyen Nguyen, Paula E Miller
Dietary supplement marketers assure the safety of their products by complying with current good manufacturing practices and a host of federal regulations, including those enforced by the Food and Drug Administration (FDA). Post-market surveillance is a key part of identifying safety problems associated with dietary supplement products. FDA requires dietary supplement marketers to provide a domestic address or phone number on product labels for consumers, family members, or health care professionals to report adverse events (AEs) associated with product use and to report all serious adverse events (SAEs) to the agency within 15 business days of receipt...
December 4, 2018: Journal of Dietary Supplements
Wei Qiu, De-Hui Huang, Shi-Fang Hou, Mei-Ni Zhang, Tao Jin, Hui-Qing Dong, Hua Peng, Chao-Dong Zhang, Gang Zhao, Yi-Ning Huang, Dong Zhou, Wei-Ping Wu, Bao-Jun Wang, Ji-Mei Li, Xing-Hu Zhang, Yan Cheng, Hai-Feng Li, Ling Li, Chuan-Zhen Lu, Xu Zhang, Bi-Tao Bu, Wan-Li Dong, Dong-Sheng Fan, Xue-Qiang Hu, Xian-Hao Xu
Background: Disease-modifying therapy is the standard treatment for patients with multiple sclerosis (MS) in remission. The primary objective of the current analysis was to assess the efficacy and safety of two teriflunomide doses (7 mg and 14 mg) in the subgroup of Chinese patients with relapsing MS included in the TOWER study. Methods: TOWER was a multicenter, multinational, randomized, double-blind, parallel-group (three groups), placebo-controlled study. This subgroup analysis includes 148 Chinese patients randomized to receive either teriflunomide 7 mg (n = 51), teriflunomide 14 mg (n = 43), or placebo (n = 54)...
December 5, 2018: Chinese Medical Journal
Daisuke Kobayashi, Morris M Salem, Thomas J Forbes, Brent M Gordon, Brian D Soriano, Vivian Dimas, Bryan H Goldstein, Carl Owada, Alexander Javois, John Bass, Thomas K Jones, Darren P Berman, Matthew J Gillespie, John W Moore, Daniel S Levi
OBJECTIVES: To report the results of the Nit-Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials. BACKGROUND: The Nit-Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013. METHODS: The PAS enrolled a total of 184 subjects greater than 6 months of age, weighing at least 5 kg, with PDAs less than 4 mm by angiography at 11 centers...
December 3, 2018: Catheterization and Cardiovascular Interventions
Xu Tian, Xiao-Ling Liu, Yuan-Ping Pi, Hui Chen, Wei-Qing Chen
Chemotherapy-induced oral mucositis is an extremely serious complication faced by cancer patients. The role of oral zinc sulfate in preventing and treating chemotherapy-induced oral mucositis remains a subject of debate. The aim of this systematic review is to assess the potential of oral zinc sulfate to alleviate this morbid condition. A systematic search was conducted electronically in PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) to capture all potential randomized controlled trials investigating efficacy and safety of oral zinc sulfate in prevention and treatment of chemotherapy-induced oral mucositis, and the retrieval time was limited from their inception to April 2018...
2018: Frontiers in Oncology
Violante Di Donato, Michele Carlo Schiavi, Valentina Iacobelli, Ottavia D'oria, Evangelos Kontopantelis, Tommaso Simoncini, Ludovico Muzii, Pierluigi Benedetti Panici
OBJECTIVE: To evaluate the tolerability and safety of ospemifene in treating dyspareunia associated with postmenopausal vulvo- vaginal atrophy (VVA). METHODS: The literature was searched through to 31 July 2018 to identify randomized controlled trials comparing ospemifene 60 mg against placebo for the treatment of VVA. Two groups of outcomes were selected: 1) side-effects, including hot flushes, urinary tract infection (UTI), headache, deep venous thrombosis (DVT), coronary heart disease (CHD), cardiovascular event (CVE), discontinuation due to side-effects, serious adverse event (SAE); 2) Safety, in relation to endometrial thickness, vaginal bleeding, breast tenderness, breast and endometrial cancer...
November 28, 2018: Maturitas
S L M Logtenberg, M L Vink, M B Godfried, I C M Beenakkers, F G Schellevis, B W Mol, C J Verhoeven
BACKGROUND: During labour, remifentanil patient-controlled analgesia is used as an alternative to neuraxial analgesia. Remifentanil is associated with hypoventilation and respiratory depression but the frequency of serious maternal and neonatal adverse events is unknown. The aim of this study was to estimate the number of serious adverse events attributed to the use of remifentanil patient-controlled analgesia during labour in The Netherlands and to investigate the circumstances (e.g...
November 2, 2018: International Journal of Obstetric Anesthesia
Joyson J Karakunnel, Nam Bui, Latha Palaniappan, Keith T Schmidt, Kenneth W Mahaffey, Briggs Morrison, William D Figg, Shivaani Kummar
BACKGROUND: With the exception of genotoxic oncology drugs, first-in-human, Phase 1 clinical studies of investigational drugs have traditionally been conducted in healthy volunteers (HVs). The primary goal of these studies is to investigate the pharmacokinetics and pharmacodynamics of a novel drug candidate, determine appropriate dosing, and document safety and tolerability. MAIN BODY: When tailored to specific study objectives, HV studies are beneficial to manufacturers and patients alike and can be applied to both non-oncology and oncology drug development...
December 4, 2018: Journal of Translational Medicine
E Michael Lewiecki, Rajani V Dinavahi, Marise Lazaretti-Castro, Peter R Ebeling, Jonathan D Adachi, Akimitsu Miyauchi, Evelien Gielen, Cassandra E Milmont, Cesar Libanati, Andreas Grauer
Romosozumab, a humanized monoclonal antibody that binds and inhibits sclerostin, has the dual effect of increasing bone formation and decreasing bone resorption. As previously reported in the pivotal FRActure study in postmenopausal woMen with ostEoporosis (FRAME), women with a T-score of ≤ -2.5 at the total hip or femoral neck received subcutaneous placebo or romosozumab once monthly for 12 months, followed by open-label subcutaneous denosumab every 6 months for an additional 12 months. Upon completion of the 24-month primary analysis period, eligible women entered the extension phase and received denosumab for an additional 12 months...
December 3, 2018: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
Naoki Ohnishi, Yuichiro Fujieda, Ryo Hisada, Hiroyuki Nakamura, Masaru Kato, Kenji Oku, Toshiyuki Bohgaki, Olga Amengual, Shinsuke Yasuda, Tatsuya Atsumi
Objective: Warfarin is regarded as the standard treatment for preventing thrombotic events in APS, but the recurrence rate is still high. Dual antiplatelet therapy (DAPT) has been shown to be effective for the prevention of acute coronary syndrome or stroke. The objective of this study was to evaluate the efficacy of DAPT for the prevention of thrombosis recurrence in APS patients with history of arterial thrombosis. Methods: This retrospective cohort study of APS patients was conducted at Hokkaido University Hospital between 1990 and 2016...
November 30, 2018: Rheumatology
Sinead Delany-Moretlwe, Carl Lombard, Deborah Baron, Linda-Gail Bekker, Busi Nkala, Khatija Ahmed, Modulakgotla Sebe, William Brumskine, Maposhane Nchabeleng, Thesla Palanee-Philips, Julius Ntshangase, Sidney Sibiya, Emilee Smith, Ravindre Panchia, Landon Myer, Jill L Schwartz, Mark Marzinke, Lynn Morris, Elizabeth R Brown, Gustavo F Doncel, Glenda Gray, Helen Rees
BACKGROUND: Young women in southern Africa have substantial risk of HIV acquisition. Female-controlled biomedical interventions are needed to mitigate this risk. We aimed to assess the safety and efficacy of a pericoitally applied tenofovir 1% gel. METHODS: We did a phase 3, double-blind, randomised, placebo-controlled trial at nine community-based clinical trial sites in South Africa to evaluate the safety and efficacy of tenofovir 1% gel. Sexually active women who were HIV negative and aged 18-30 years were enrolled...
November 2018: Lancet Infectious Diseases
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