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Trial sequential analysis

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https://www.readbyqxmd.com/read/29790586/pharmacokinetic-and-pharmacodynamic-model-for-analysis-of-adalimumab-administered-for-crohn-s-disease
#1
Koji Kimura, Atsushi Yoshida, Risa Takayanagi, Yasuhiko Yamada
Adalimumab (ADA) is used as a therapeutic agent for Crohn's disease (CD). Although that dosage regimen has been established through clinical trial experience, it has not been analyzed theoretically. In the present study, we analyzed of sequential changes of the Crohn's disease activity index (CDAI) after repeated administrations of ADA using a pharmacokinetic and pharmacodynamic model. In addition, we analyzed the validity of the dosage regimen, and potential efficacy gained by increasing the dose and reducing the interval of administration...
May 23, 2018: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/29789778/conscious-sedation-versus-general-anesthesia-for-patients-with-acute-ischemic-stroke-undergoing-endovascular-therapy-a-systematic-review-and-meta-analysis
#2
REVIEW
Ren Jing, Hui-Jun Dai, Fei Lin, Wan-Yun Ge, Ling-Hui Pan
The aim of this study is to compare the effect of conscious sedation (CS) with general anesthesia (GA) on clinical outcomes in patients with acute ischemic stroke (AIS) undergoing endovascular therapy (EVT). MEDLINE, EMBASE, and Cochrane Central Registers of Controlled Trials (from inception to July 2017) were searched for reports on CS and GA of AIS undergoing EVT. Two reviewers assessed the eligibility of the identified studies and extracted data. Data were analyzed using the fixed-effects model, and the sources of heterogeneity were explored by sensitive analysis...
2018: BioMed Research International
https://www.readbyqxmd.com/read/29782398/benefit-and-harm-of-adding-epinephrine-to-a-local-anesthetic-for-neuraxial-and-locoregional-anesthesia-a-meta-analysis-of-randomized-controlled-trials-with-trial-sequential-analyses
#3
Clément Tschopp, Martin R Tramèr, Alexis Schneider, Maroun Zaarour, Nadia Elia
BACKGROUND: This systematic review examines the benefit and harm of adding epinephrine to local anesthetics for epidural, intrathecal, or locoregional anesthesia. METHODS: We searched electronic databases to October 2017 for randomized trials comparing any local anesthetic regimen combined with epinephrine, with the same local anesthetic regimen without epinephrine, reporting on duration of analgesia, time to 2 segments regression, or any adverse effects. Trial quality was assessed using the Cochrane risk of bias tool and a random-effects model was used...
May 17, 2018: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/29773835/levosimendan-in-patients-with-left-ventricular-dysfunction-undergoing-cardiac-surgery-a-meta-analysis-and-trial-sequential-analysis-of-randomized-trials
#4
Zhenhua Xing, Liang Tang, Pengfei Chen, Jiabing Huang, Xiaofan Peng, Xinqun Hu
Patients with left ventricular dysfunction (LVD) undergoing cardiac surgery have a high mortality rate. Levosimendan, a calcium sensitizer, improves myocardial contractility without increasing myocardial oxygen demand. It is not clear whether levosimendan can reduce mortality in cardiac surgery patients with LVD. The PubMed, Embase, and Cochrane Central databases were searched to identify randomized trials comparing levosimendan with conventional treatment in cardiac surgery patients with LVD. We derived pooled risk ratios (RRs) with random effects models...
May 17, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29773680/macrophage-migration-inhibitory-factor-794-catt-microsatellite-polymorphism-and-risk-of-tuberculosis-a-meta-analysis
#5
Mingbiao Ma, Lvyan Tao, Aihua Liu, Zhang Liang, Jiaru Yang, Yun Peng, Xiting Dai, Ruolan Bai, Zhenhua Ji, Miaomiao Jian, Fukai Bao
Tuberculosis (TB) is a chronic infectious disease that has been threatening public health for many years. Several studies have shown the relationship between the macrophage migration inhibitory factor-794CATT ( MIF-794CATT ) microsatellite polymorphism and susceptibility of tuberculosis ( TB ). However, the results remain inconclusive. Therefore, we aim to find out the impact of MIF-794 CATT microsatellite polymorphism on risk of TB by a comprehensive meta-analysis. We conducted a systematic study search in PubMed,Embase, the Cochrane Library, and the China National Knowledge Infrastructure ( CNKI ) up to October, 2017...
May 17, 2018: Bioscience Reports
https://www.readbyqxmd.com/read/29768349/comparison-of-multiple-interventions-for-older-adults-with-alzheimer-disease-or-mild-cognitive-impairment-a-prisma-compliant-network-meta-analysis
#6
Jing-Hong Liang, Yong Xu, Lu Lin, Rui-Xia Jia, Hong-Bo Zhang, Lei Hang
BACKGROUND: The increasing prevalence of Alzheimer disease (AD) emphasizes the need for effective treatments. Both pharmacological therapies such as nutrition therapy (NT) and nonpharmacologic therapies including traditional treatment or personalized treatment (e.g., physical exercise, music therapy, computerized cognitive training) have been approved for the treatment of AD or mild cognitive impairment (MCI) in numerous areas. METHODS: The aim of this study was to compare 4 types of interventions, physical exercise (PE), music therapy (MT), computerized cognitive training (CCT), and NT, in older adults with mild to moderate AD or MCI and identify the most effective intervention for their cognitive function...
May 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29766362/exploration-of-tumour-infiltrating-lymphocytes-as-a-predictive-biomarker-for-adjuvant-endocrine-therapy-in-early-breast-cancer
#7
Erik J Blok, Charla C Engels, Geeske Dekker-Ensink, Elma Meershoek-Klein Kranenbarg, Hein Putter, Vincent T H B M Smit, Gerrit-Jan Liefers, James P Morden, Judith M Bliss, R Charles Coombes, John M S Bartlett, Judith R Kroep, Cornelis J H van de Velde, Peter J K Kuppen
PURPOSE: Tumour-infiltrating lymphocytes (TILs) have been shown to be prognostic for disease-free survival and predictive for the benefit of chemotherapy in patients with early breast cancer, but have not been studied for endocrine therapy. EXPERIMENTAL DESIGN: The number of CD8-positive TILs was assessed in a subcohort of 236 patients in the Intergroup Exemestane Study. AQ After 2-3 years of adjuvant tamoxifen, AQpatients were randomized between the schemes of continuation for 5 years on tamoxifen and switching to exemestane...
May 15, 2018: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29762873/l-ornithine-l-aspartate-for-prevention-and-treatment-of-hepatic-encephalopathy-in-people-with-cirrhosis
#8
REVIEW
Ee Teng Goh, Caroline S Stokes, Sandeep S Sidhu, Hendrik Vilstrup, Lise Lotte Gluud, Marsha Y Morgan
BACKGROUND: Hepatic encephalopathy is a common complication of cirrhosis and has high associated morbidity and mortality. The condition is classified as overt if it is clinically apparent or minimal if only evident though psychometric testing. The exact pathogenesis of this syndrome is unknown although ammonia is thought to play a key role. L-ornithine L-aspartate has ammonia-lowering properties and may, therefore, benefit people with cirrhosis and hepatic encephalopathy. OBJECTIVES: To evaluate the beneficial and harmful effects of L-ornithine L-aspartate versus placebo, no intervention, or other active interventions in people with cirrhosis and hepatic encephalopathy...
May 15, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29761473/glucocorticosteroids-for-infants-with-biliary-atresia-following-kasai-portoenterostomy
#9
REVIEW
Athanasios Tyraskis, Christopher Parsons, Mark Davenport
BACKGROUND: Biliary atresia is a life-threatening disease characterised by progressive destruction of both intra- and extra-hepatic biliary ducts. The mainstay of treatment is Kasai portoenterostomy, as soon as the disease has been confirmed. Glucocorticosteroids are steroid hormones which act on the glucocorticoid receptor and have a range of metabolic and immunomodulatory effects. Glucocorticosteroids are used to improve the postoperative outcomes in infants who have undergone Kasai portoenterostomy...
May 14, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29761216/low-dose-corticosteroids-for-adult-patients-with-septic-shock-a-systematic-review-with-meta-analysis-and-trial-sequential-analysis
#10
Sofie Louise Rygård, Ethan Butler, Anders Granholm, Morten Hylander Møller, Jeremy Cohen, Simon Finfer, Anders Perner, John Myburgh, Balasubramanian Venkatesh, Anthony Delaney
PURPOSE: To assess the effect of low dose corticosteroids on outcomes in adults with septic shock. METHODS: We systematically reviewed randomised clinical trials (RCTs) comparing low-dose corticosteroids to placebo in adults with septic shock. Trial selection, data abstraction and risk of bias assessment were performed in duplicate. The primary outcome was short-term mortality. Secondary and tertiary outcomes included longer-term mortality, adverse events, quality of life, and duration of shock, mechanical ventilation and ICU stay...
May 14, 2018: Intensive Care Medicine
https://www.readbyqxmd.com/read/29760659/long-term-efficacy-of-maintenance-therapy-for-multiple-myeloma-a-quantitative-synthesis-of-22-randomized-controlled-trials
#11
Jie-Li Li, Guang-Yu Fan, Yu-Jie Liu, Zi-Hang Zeng, Jing-Juan Huang, Zong-Ming Yang, Xiang-Yu Meng
We aimed to quantitatively synthesize data from randomized controlled trials (RCTs) concerning maintenance for multiple myeloma (MM). We searched electronic literature databases and conference proceedings to identify relevant RCTs. We selected eligible RCTs using predefined selection criteria. We conducted meta-analysis comparing maintenance containing new agents and conventional maintenance, and subgroup analysis by transplantation status and mainstay agent as well. We performed trial sequential analysis (TSA) to determine adequacy of sample size for overall and subgroup meta-analyses...
2018: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29760027/case-management-in-primary-care-for-frequent-users-of-health-care-services-a-mixed-methods-study
#12
Catherine Hudon, Maud-Christine Chouinard, Marie-France Dubois, Pasquale Roberge, Christine Loignon, Éric Tchouaket, Mireille Lambert, Émilie Hudon, Fatoumata Diadiou, Danielle Bouliane
PURPOSE: This study aimed to evaluate the effects of the V1SAGES case management intervention (Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support) for frequent users of health care services with chronic disease and complex care needs on psychological distress and patient activation. METHODS: We used a 2-phase sequential mixed methods design. The first phase was a pragmatic randomized controlled trial with intention-to-treat analysis that measured the effects of the intervention compared with usual care on psychological distress and patient activation before and after 6 months...
May 2018: Annals of Family Medicine
https://www.readbyqxmd.com/read/29757894/immunosuppression-is-associated-with-clinical-features-and-relapse-risk-of-b-cell-posttransplant-lymphoproliferative-disorder-a-retrospective-analysis-based-on-the-prospective-international-multicenter-ptld-1-trials
#13
Heiner Zimmermann, Nina Babel, Daan Dierickx, Franck Morschhauser, Peter Mollee, Jan M Zaucha, Martin H Dreyling, Ulrich Dührsen, Petra Reinke, Gregor Verhoef, Marion Subklewe, Andreas Hüttmann, Thomas Tousseyn, Emmanuel Bachy, Ingeborg A Hauser, Corrado Tarella, Eric Van Den Neste, Olivier Gheysens, Ioannis Anagnostopoulos, Veronique Leblond, Hanno Riess, Sylvain Choquet, Ralf U Trappe
BACKGROUND: Current guideline recommendations for immunosuppression reduction after diagnosis of posttransplant lymphoproliferative disorder (PTLD) include stopping antimetabolites, reducing calcineurin inhibitors and maintaining corticosteroids. However, the effect of immunosuppression on PTLD relapse risk after up-to-date therapy is unclear. METHODS: This is a retrospective analysis of immunosuppression, patient baseline characteristics and relapse risk measured as landmark time to progression (TTP) starting 1 year after start of therapy in 159 patients with B cell PTLD after solid organ transplantation treated in the prospective, international, multicenter PTLD-1 trials with either sequential treatment (rituximab followed by CHOP chemotherapy) or risk-stratified sequential treatment (rituximab followed by rituximab or R-CHOP immunochemotherapy)...
May 11, 2018: Transplantation
https://www.readbyqxmd.com/read/29750696/patient-controlled-versus-clinician-controlled-sedation-with-propofol-systematic-review-and-meta-analysis-with-trial-sequential-analyses
#14
Lukas Kreienbühl, Nadia Elia, Elvire Pfeil-Beun, Bernhard Walder, Martin R Tramèr
BACKGROUND: Sedation with propofol is frequently used to facilitate diagnostic and therapeutic procedures. Propofol can be administrated by the patient (patient-controlled sedation [PCS]) or by a clinician (clinician-controlled sedation [CCS]). We aimed to compare these 2 techniques. METHODS: PubMed, Embase, CENTRAL, and trial registries were searched up to October 2017 for randomized controlled trials comparing PCS with CCS with propofol. The primary end points were the risks of presenting at least 1 episode of oxygen desaturation, arterial hypotension, and bradycardia, and the risk of requiring a rescue intervention (pharmacologic therapies or physical maneuvers) for sedation-related adverse events...
May 9, 2018: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/29750261/validation-of-previously-reported-predictors-for-radiation-induced-hypothyroidism-in-nasopharyngeal-cancer-patients-treated-with-intensity-modulated-radiation-therapy-a-post-hoc-analysis-from-a-phase-iii-randomized-trial
#15
Chawalit Lertbutsayanukul, Sarin Kitpanit, Anussara Prayongrat, Danita Kannarunimit, Buntipa Netsawang, Chakkapong Chakkabat
This study aimed to validate previously reported dosimetric parameters, including thyroid volume, mean dose, and percentage thyroid volume, receiving at least 40, 45 and 50 Gy (V40, V45 and V50), absolute thyroid volume spared (VS) from 45, 50 and 60 Gy (VS45, VS50 and VS60), and clinical factors affecting the development of radiation-induced hypothyroidism (RHT). A post hoc analysis was performed in 178 euthyroid nasopharyngeal cancer (NPC) patients from a Phase III study comparing sequential versus simultaneous-integrated boost intensity-modulated radiation therapy...
May 10, 2018: Journal of Radiation Research
https://www.readbyqxmd.com/read/29738697/prognostic-and-clinical-significance-of-histone-deacetylase-1-expression-in-breast-cancer-a-meta-analysis
#16
REVIEW
Weiqiang Qiao, Heyang Liu, Ruidong Liu, Qipeng Liu, Ting Zhang, Wanying Guo, Peng Li, Miao Deng
BACKGROUND: There are conflicting reports about the role of histone deacetylase 1 (HDAC1) in breast cancer prognosis. Here, we conducted a meta-analysis to investigate the prognostic significance of HDAC1 in breast cancer. MATERIALS AND METHODS: We searched different databases to identify studies evaluating the association between HDAC1 expression and its prognostic value in breast cancer. The pooled hazard ratios (HRs) and odds radios (ORs) with 95% confidence intervals (95% CIs) were calculated from these studies to assess specific correlation...
May 5, 2018: Clinica Chimica Acta; International Journal of Clinical Chemistry
https://www.readbyqxmd.com/read/29732536/cognitive-behavioral-therapy-for-insomnia-to-reduce-chronic-migraine-a-sequential-bayesian-analysis
#17
REVIEW
Todd A Smitherman, Alexander J Kuka, Anne H Calhoun, A Brooke Pellegrino Walters, Rachel E Davis-Martin, Carrie E Ambrose, Jeanetta C Rains, Timothy T Houle
BACKGROUND: Insomnia is frequently comorbid with chronic migraine, and small trials suggest that cognitive-behavioral treatment of insomnia (CBTi) may reduce migraine frequency. This study endeavored to provide a quantitative synthesis of existing CBTi trials for adults with chronic migraine using Bayesian statistical methods, given their utility in combining prior knowledge with sequentially gathered data. METHODS: Completer analyses of 2 randomized trials comparing CBTi to a sham control intervention (Calhoun and Ford, 2007; Smitherman et al, 2016) were used to quantify the effects of a brief course of treatment on headache frequency...
May 6, 2018: Headache
https://www.readbyqxmd.com/read/29728098/the-21-gene-recurrence-score%C3%A2-assay-predicts-distant-recurrence-in-lymph-node-positive-hormone-receptor-positive-breast-cancer-patients-treated-with-adjuvant-sequential-epirubicin-and-docetaxel-based-or-epirubicin-based-chemotherapy-pacs-01-trial
#18
Frédérique Penault-Llorca, Thomas Filleron, Bernard Asselain, Frederick L Baehner, Pierre Fumoleau, Magali Lacroix-Triki, Joseph M Anderson, Carl Yoshizawa, Diana B Cherbavaz, Steven Shak, Lise Roca, Christine Sagan, Jérôme Lemonnier, Anne-Laure Martin, Henri Roché
BACKGROUND: The 21-gene Recurrence Score (RS) result predicts outcome and chemotherapy benefit in node-negative and node-positive (N+), estrogen receptor-positive (ER+) patients treated with endocrine therapy. The purpose of this study was to evaluate the prognostic impact of RS results in N+, hormone receptor-positive (HR+) patients treated with adjuvant chemotherapy (6 cycles of FEC100 vs. 3 cycles of FEC100 followed by 3 cycles of docetaxel 100 mg/m2 ) plus endocrine therapy (ET) in the PACS-01 trial (J Clin Oncol 2006;24:5664-5671)...
May 4, 2018: BMC Cancer
https://www.readbyqxmd.com/read/29727586/efficacy-and-safety-of-iron-chelators-in-thalassemia-and-sickle-cell-disease-a-multiple-treatment-comparison-network-meta-analysis-and-trial-sequential-analysis
#19
Kannan Sridharan, Gowri Sivaramakrishnan
BACKGROUND: To compare the efficacy and safety of desferrioxamine (DFO), deferiprone (DFP), deferasirox (DFX) and silymarin in patients with either thalassemia or sickle cell disorder through network meta-analysis. METHODS: Electronic databases were searched for appropriate randomized clinical trials comparing iron chelators in patients with iron overload. Random effects model was used to generate direct, indirect and mixed treatment comparison pooled estimates for the following outcomes: serum ferritin, liver iron concentration (LIC), changes in serum ferritin, mortality, urine iron excretion, adverse events, neutropenia, agranulocytosis and number of patients withdrawing the chelating therapy...
May 4, 2018: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/29726345/mortality-and-morbidity-in-acutely-ill-adults-treated-with-liberal-versus-conservative-oxygen-therapy-iota-a-systematic-review-and-meta-analysis
#20
Derek K Chu, Lisa H-Y Kim, Paul J Young, Nima Zamiri, Saleh A Almenawer, Roman Jaeschke, Wojciech Szczeklik, Holger J Schünemann, John D Neary, Waleed Alhazzani
BACKGROUND: Supplemental oxygen is often administered liberally to acutely ill adults, but the credibility of the evidence for this practice is unclear. We systematically reviewed the efficacy and safety of liberal versus conservative oxygen therapy in acutely ill adults. METHODS: In the Improving Oxygen Therapy in Acute-illness (IOTA) systematic review and meta-analysis, we searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, HealthSTAR, LILACS, PapersFirst, and the WHO International Clinical Trials Registry from inception to Oct 25, 2017, for randomised controlled trials comparing liberal and conservative oxygen therapy in acutely ill adults (aged ≥18 years)...
April 28, 2018: Lancet
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