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randomized controlled trial toxicity

Manuel Barrios, Luis C Orozco, Elena E Stashenko
The effects of in vivo cocoa-based supplementation were studied as a preconditioning treatment for ex vivo acute oxidative conditions in a controlled randomized clinical trial. Subjects were 100 healthy young men at Universidad Industrial de Santander blinded to the intervention and divided into two groups: The intervention group (n = 50) receiving 30 g of cocoa powder and 50 g of dark chocolate/d for 1 week with the remaining subjects receiving placebo. Cocoa products preconditioning for 1 week resulted in modifications in the susceptibility of plasma lipids over ex vivo oxidative conditions with effects of i) a significant increase in the oxidative resistance of plasma lipids measured by dienes formation (4...
August 2018: Clinical Nutrition ESPEN
Yuko Shimizu-Motohashi, Terumi Murakami, En Kimura, Hirofumi Komaki, Norio Watanabe
BACKGROUND: Exon skipping has been considered a promising therapeutic approach for Duchenne muscular dystrophy (DMD). Eteplirsen received conditional approval in the United States in 2016. To date, no systematic reviews or meta-analyses of randomized controlled trials (RCTs) of exon skipping drugs have been published to determine the pooled estimates for the effect of exon skipping in treating DMD. METHODS: A systematic review and meta-analysis of double-blind RCTs comparing exon-skipping drugs with placebo in DMD was performed...
June 15, 2018: Orphanet Journal of Rare Diseases
Hye-Yoon Lee, Oh-Jin Kwon, Jung-Eun Kim, Mikyeong Kim, Ae-Ran Kim, Hyo-Ju Park, Jung-Hyo Cho, Joo-Hee Kim, Sun-Mi Choi
BACKGROUND: The prevalence of functional constipation (FC) is 3-27%, and FC has been reported to cause discomfort in daily life and various complications. The treatment for FC depends on laxatives, and thus, effective and non-toxic alternative treatments are needed. METHODS: We conducted a randomised, sham-controlled parallel-design, pilot trial. Participants with FC were randomly assigned to either the real acupuncture (RA) or sham acupuncture (SA) group. The RA consisted of eight fixed acupuncture points (bilateral ST25, ST27, BL52 and BL25) and four additional points targeted to the individual based on Traditional Korean medicine (TKM)...
June 15, 2018: BMC Complementary and Alternative Medicine
Sarah Brown, Colin C Everett, Kamran Naraghi, Claire Davies, Bryony Dawkins, Claire Hulme, Christopher McCabe, Sue Pavitt, Paul Emery, Linda Sharples, Maya H Buch
BACKGROUND: Rheumatoid arthritis (RA), the most common autoimmune disease in the UK, is a chronic systemic inflammatory arthritis that affects 0.8% of the UK population. OBJECTIVES: To determine whether or not an alternative class of biologic disease-modifying antirheumatic drugs (bDMARDs) are comparable to rituximab in terms of efficacy and safety outcomes in patients with RA in whom initial tumour necrosis factor inhibitor (TNFi) bDMARD and methotrexate (MTX) therapy failed because of inefficacy...
June 2018: Health Technology Assessment: HTA
Steffen Moritz, Brooke C Schneider, Judith Peth, Sönke Arlt, Lena Jelinek
Metacognitive Training for Depression (D-MCT) is a highly standardized group program targeted at depression-related ("Beckian") emotional as well as cognitive biases, including mood-congruent and false memory. While prior results are promising with respect to psychopathological outcomes (depression), it is unclear whether D-MCT also meets its goal of improving cognitive biases, such as false memories. In the framework of a randomized controlled trial (registered trial, DRKS00007907), we investigated whether D-MCT is superior to an active control condition (health training, HT) in reducing the susceptibility of depressed patients for false memories...
June 8, 2018: European Psychiatry: the Journal of the Association of European Psychiatrists
Wai-Tong Ng, Stewart Y Tung, Victor Lee, Roger K C Ngan, Horace C W Choi, Lucy L K Chan, To-Wai Leung, Lillian L Siu, Tai-Xiang Lu, Terence Tan, Eng-Huat Tan, Henry C K Sze, Alice W Y Ng, Harry H Y Yiu, Brian O'Sullivan, Rick Chappell, Anne W M Lee
PURPOSE: This is an updated combined analysis of 2 randomized studies (NPC-9901 and NPC-9902 trials) to evaluate the 10-year outcome attributed to the addition of concurrent-adjuvant chemotherapy for advanced locoregional nasopharyngeal carcinoma (NPC). PATIENTS AND METHODS: Eligible patients with stage III-IVB nonkeratinizing NPC were randomly assigned to radiation therapy alone (RT: 218 patients) or chemoradiation therapy (CRT: 223 patients) using 3 cycles of cisplatin (100 mg/m2 ) concurrent with RT, followed by 3 cycles of cisplatin (80 mg/m2 ) and fluorouracil (1000 mg/m2 /day for 4 days)...
May 2, 2018: International Journal of Radiation Oncology, Biology, Physics
Yungan Tao, Anne Auperin, Christian Sire, Laurent Martin, Cedric Khoury, Philippe Maingon, Etienne Bardet, Marie-Christine Kaminsky, Michel Lapeyre, Thierry Chatellier, Marc Alfonsi, Yoann Pointreau, Eric Jadaud, Bernard Géry, Ayman Zawadi, Jean-Marc Tourani, Brigitte Laguerre, Alexandre Coutte, Séverine Racadot, Ali Hasbini, Emanuelle Malaurie, Christian Borel, Nicolas Meert, Alexandre Cornely, Nathalie Ollivier, Odile Casiraghi, Xu Shan Sun, Jean Bourhis
Purpose To investigate the effect of adding concurrent chemotherapy (CT) to cetuximab plus radiotherapy (RT; CT-cetux-RT) compared with cetuximab plus RT (cetux-RT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Patients and Methods In this phase III randomized trial, patients with N0-2b, nonoperated, stage III or IV (nonmetastatic) LA-SCCHN were enrolled. Patients received once-daily RT up to 70 Gy with weekly cetuximab or with weekly cetuximab and concurrent carboplatin and fluorouracil (three cycles)...
June 7, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
F Poggio, M Bruzzone, M Ceppi, N F Pondé, G La Valle, L Del Mastro, E de Azambuja, M Lambertini
Background: The role of platinum-based neoadjuvant chemotherapy in triple-negative breast cancer (TNBC) patients is highly controversial and it is not endorsed by current guidelines. Our meta-analysis aimed to better elucidate its activity, efficacy and safety. Material and methods: A systematic search of Medline, Web of Science and conferences proceedings up to 30 October 2017 was carried out to identify randomized controlled trials (RCTs) investigating platinum-based versus platinum-free neoadjuvant chemotherapy in TNBC patients...
June 4, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Jordi Bruna, Roser Velasco
Chemotherapy-induced peripheral neuropathy is a very frequent neurological complication in cancer. Oxaliplatin (OXA) is a platinum analogue used as a first-line agent in the treatment of colorectal cancer. OXA induced peripheral neuropathy (OIN) is the main toxicity both during and after the completion of chemotherapy that presents as two distinct syndromes: acute and chronic neuropathy. None of the neuroprotective agents previously tested had prevented or limited the acute and/or chronic OIN. MR309 (previously developed as E-52862) is a novel selective sigma-1 receptor (S1R) antagonist with preclinical analgesic activity in OXA-induced neuropathic pain in animal models...
May 2018: Neural Regeneration Research
Fauzia Shaikh, Jessica Chew, Tsivia Hochman, Juhi Purswani, Olivier Maisonet, Elecia Peat, Nelly Huppert, Benjamin T Cooper, Moses Tam, Judith D Goldberg, Carmen A Perez, Silvia C Formenti, Naamit K Gerber
PURPOSE: Hypofractionated whole-breast radiation therapy (RT) has proved to be equivalent to conventionally fractionated RT in multiple randomized trials. There is controversy regarding its use in younger women because of their underrepresentation in trials and the concern for late toxicity. We evaluated disease control and cosmetic outcomes in patients aged <50 years treated with hypofractionated RT in 4 prospective single-institutional trials. METHODS AND MATERIALS: From 2003 to 2015, 1313 patients were enrolled in 4 prospective protocols investigating the use of adjuvant hypofractionated RT after breast-conserving surgery with a daily or weekly concomitant boost...
April 19, 2018: International Journal of Radiation Oncology, Biology, Physics
Shirin Kalimuddin, Yvonne F Z Chan, Rachel Phillips, Siew Pei Ong, Sophia Archuleta, David Chien Lye, Thuan Tong Tan, Jenny G H Low
BACKGROUND: Studies have suggested the reduced effectiveness of vancomycin against methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections with high vancomycin minimum inhibitory concentrations. Alternative agents such as daptomycin may be considered. We conducted a randomized controlled study comparing daptomycin against vancomycin in the treatment of MRSA bloodstream infections with high vancomycin minimum inhibitory concentrations. METHODS: Patients were randomized to receive vancomycin or daptomycin for a minimum of 14 days...
June 1, 2018: Trials
Clotilde Chatre, François Roubille, Hélène Vernhet, Christian Jorgensen, Yves-Marie Pers
INTRODUCTION: Chloroquine and hydroxychloroquine are widely used in the long-term treatment of connective tissue disease and usually considered safe. However, chloroquine- or hydroxychloroquine-related cardiac disorder is a rare but severe adverse event, which can lead to death. This systematic review investigates cardiac complications attributed to chloroquine and hydroxychloroquine. METHODS: PubMED, EMBASE, and Cochrane database searches were conducted using keywords derived from MeSH terms...
June 1, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Soraia Younan, Gabriel Zanuto Sakita, João Gabriel Younan Coluna, Marcos Natal Rufino, Rogéria Keller, Hermann Bremer-Neto
BACKGROUND: The objective of this study was to evaluate the nutritional, physiological, and biochemical effects of dietary supplementation of an association of probiotic bacteria in rats intoxicated with chromium (VI). Ninety-six male rats, recently weaned, were randomly divided into 8 groups (n=12): Control, DK12, DK24, and DK36 (0, 0.12, 0.24, and 0.36 of K2 Cr2 O7 incorporated in the basal feed, respectively) and groups Prob, DK12+Prob, DK24+Prob, and DK36+Prob received a progressive dose of 0, 0...
May 30, 2018: Journal of the Science of Food and Agriculture
Shaodong Tong, Zhaohui Qin, Minghui Wan, Longzhen Zhang, Yan Cui, Yuanhu Yao
Background: Non-small cell lung cancer (NSCLC) accounts for 85% to 90% of lung cancer cases. At diagnosis, around 30% of NSCLC patients are already at stage IIIA (N2). One standard treatment for this stage is induction chemotherapy followed by surgery, whether induction chemoradiotherapy is superior to induction chemotherapy remains uncertain. We therefore performed a systematic review and meta-analysis of published randomized control trials to evaluate the therapeutic efficacy and toxicity of induction chemoradiotherapy versus induction chemotherapy for potentially resectable stage IIIA (N2) NSCLC...
April 2018: Journal of Thoracic Disease
Meng Lv, Jingwen Deng, Nan Tang, Yuejin Zeng, Chuanjian Lu
Background: Psoriasis is a chronic autoimmune-mediated skin disease that is characterized by persistent localized erythematous scaly plaque. Tripterygium wilfordii Hook F (TwHF), a well-known Chinese medicine that has been used for centuries in China to treat immune diseases, inflammation, and tumor, is accompanied by a degree of toxic effects. Its clinical efficacy and safety on psoriasis are incompletely understood. Aim: To summarize evidence concerning the efficacy and safety of TwHF in treating psoriasis ...
2018: Evidence-based Complementary and Alternative Medicine: ECAM
Zi Li, Xiao Hong Tang, Qi Li, Wen-Juan Zhang, Tian Tao, Tao Zhu
BACKGROUND: The ultrasound-guided transversus abdominis plane (TAP) block is generally used for analgesia but not for anesthesia. A TAP block has a partial analgesic effect on the parietal peritoneum in abdominal surgeries. We hypothesized that an ultrasound-guided oblique subcostal TAP block, used as the principal anesthesia technique, could provide a better anesthetic effect on peritoneum stimulation in peritoneal dialysis catheter (PDC) implantation in end-stage renal diseases (ESRD) patients than local anesthetic infiltration (LAI)...
May 2018: Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis
Rana R McKay, Dominick Bossé, Kathryn P Gray, M Dror Michaelson, Katherine M Krajewski, Heather A Jacene, Meghara Meghara Walsh, Joaquim Bellmunt, Mark Pomerantz, Lauren C Harshman, Toni K Choueiri
PURPOSE: This study investigates the biologic activity of radium-223 with vascular endothelial growth factor (VEGF)-targeted therapy in patients with advanced renal cell carcinoma (aRCC) and bone metastases. EXPERIMENTAL DESIGN: Fifteen treatment-naïve patients (n=15) received pazopanib 800 mg orally once-daily and 15 previously-treated patients received sorafenib 400 mg orally twice-daily. Radium-223 55 kilobecquerel/kg was administered concurrently every four weeks for up to 6 infusions in both cohorts...
May 30, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Reham Abdel-Wahab, Gauri R Varadhachary, Priya R Bhosale, Xuemei Wang, David R Fogelman, Rachna T Shroff, Michael J Overman, Robert A Wolff, Milind Javle
BACKGROUND: Binding of insulin-like growth factor-I (IGF-1) to its receptor (IGF-1R) initiates downstream signals that activate PI3K/Akt/mTOR and MEK/Erk pathways, which stimulate cancer cell proliferation and induce drug resistance. Cross talk between IGF-1R and epidermal growth factor receptor (EGFR) mediates resistance to anti-EGFR agents. We studied safety, tolerability, and outcomes of MK-0646, IGF-1 monoclonal antibody, in combination with gemcitabine (G) ± erlotinib (E) in metastatic pancreatic cancer...
May 30, 2018: Journal of Hematology & Oncology
Mona Khalaj, Amene Saghazadeh, Elham Shirazi, Mohammad-Reza Shalbafan, Kaveh Alavi, Mitera Hakim Shooshtari, Fatemeh Yousefi Laksari, Maryamalsadat Hosseini, Mohammad-Reza Mohammadi, Shahin Akhondzadeh
Inflammation as well as glutamate excitotoxicity have been proposed to participate in the propagation of autism. Palmitoylethanolamide (PEA) is an endocannabinoid proven to prevent glutamatergic toxicity and inhibit inflammatory responses simultaneously. The present randomized, parallel group, double-blind placebo-controlled trial is the first study depicted to probe the efficacy of co-treatment with risperidone and PEA over 10 weeks in children with autism. Seventy children (aged 4-12 years) with autism and moderate to severe symptoms of irritability were randomly assigned to two treatment regimens...
May 1, 2018: Journal of Psychiatric Research
Chintan Shah, Rohit Bishnoi, Yu Wang, Fei Zou, Harini Bejjanki, Samip Master, Jan S Moreb
Objective: Carfilzomib (Carf) is a second-generation proteasome inhibitor approved for patients with relapsed and/or refractory multiple myeloma (RRMM) who failed ≥ 1 prior lines of therapy. We performed a systematic review of Carf literature with meta-analysis to determine the efficacy and safety in RRMM patients. Methods: Based on literature search, we included a total of 14 eligible phase I/II, phase II and phase III Carf based clinical trials. The cumulative incidence and odds ratios (OR) were calculated with random effect model, using ''R'' software with metaphor package...
May 4, 2018: Oncotarget
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