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randomized controlled trial toxicity

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https://www.readbyqxmd.com/read/28087591/clinical-trials-in-antineutrophil-cytoplasmic-antibody-associated-vasculitis-what-we-have-learnt-so-far-and-what-we-still-have-to-learn
#1
Divi Cornec, Emilie Cornec-Le Gall, Ulrich Specks
The prognosis of the antineutrophil cytoplasmic antibody associated vasculitides (AAV), microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA) and eosinophilic GPA (EGPA), has been fundamentally improved over the last five decades by the use of glucocorticoids and immunosuppressants, turning them from consistently fatal diseases into chronic conditions. The long-term course is now largely determined by the frequency of disease flares and by accruing damage caused by disease activity and treatment-related comorbidities...
January 12, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28079805/toxicities-of-different-first-line-chemotherapy-regimens-in-the-treatment-of-advanced-ovarian-cancer-a-network-meta-analysis
#2
Chang-Ping Qu, Gui-Xia Sun, Shao-Qin Yang, Jun Tian, Jin-Ge Si, Yi-Feng Wang
BACKGROUND: Ovarian cancer (OC) is the 5th leading cause of cancer-related deaths around the world, and several chemotherapy regimens have been applied in the treatment of OC. We aim to compare toxicities of different chemotherapy regimens in the treatment of advanced ovarian cancer (AOC) using network meta-analysis. METHODS: Literature research in Cochrane Library, PubMed, and EMBASE was performed up to November 2015. Eligible randomized controlled trials (RCTs) of different chemotherapy regimens were included...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28076709/phase-3-trial-of-177-lu-dotatate-for-midgut-neuroendocrine-tumors
#3
Jonathan Strosberg, Ghassan El-Haddad, Edward Wolin, Andrew Hendifar, James Yao, Beth Chasen, Erik Mittra, Pamela L Kunz, Matthew H Kulke, Heather Jacene, David Bushnell, Thomas M O'Dorisio, Richard P Baum, Harshad R Kulkarni, Martyn Caplin, Rachida Lebtahi, Timothy Hobday, Ebrahim Delpassand, Eric Van Cutsem, Al Benson, Rajaventhan Srirajaskanthan, Marianne Pavel, Jaime Mora, Jordan Berlin, Enrique Grande, Nicholas Reed, Ettore Seregni, Kjell Öberg, Maribel Lopera Sierra, Paola Santoro, Thomas Thevenet, Jack L Erion, Philippe Ruszniewski, Dik Kwekkeboom, Eric Krenning
Background Patients with advanced midgut neuroendocrine tumors who have had disease progression during first-line somatostatin analogue therapy have limited therapeutic options. This randomized, controlled trial evaluated the efficacy and safety of lutetium-177 ((177)Lu)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors. Methods We randomly assigned 229 patients who had well-differentiated, metastatic midgut neuroendocrine tumors to receive either (177)Lu-Dotatate (116 patients) at a dose of 7...
12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28076696/proton-pump-inhibitors-for-preventing-non-steroidal-anti-inflammatory-drug-induced-gastrointestinal-toxicity-a-systematic-review
#4
Man Yang, Min He, Miao Zhao, Bing Zou, Jun Liu, Ling-Min Luo, Qiu-Lan Li, Jun-Hui He, Ping-Guang Lei
OBJECTIVE: Proton pump inhibitors (PPIs) are recommended for preventing gastrointestinal lesions induced by non-steroidal anti-inflammatory drug (NSAID). We performed this study (1) to evaluate the effectiveness and safety of PPIs, (2) to explore the association between effectiveness and potential influential factors, and (3) to investigate the comparative effect of different PPIs. METHODS: MEDLINE, EMBASE, and the Cochrane Library were searched to identify randomized controlled trials comparing different classes of PPIs, or comparing PPIs with placebo, H2 receptor antagonists or misoprostol in NSAIDs users...
January 11, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28069654/reduced-chance-of-hearing-loss-associated-with-therapeutic-drug-monitoring-of-aminoglycosides-in-the-treatment-of-multidrug-resistant-tuberculosis
#5
R van Altena, J A Dijkstra, M E van der Meer, J F Borjas Howard, J G W Kosterink, D van Soolingen, T S van der Werf, J W C Alffenaar
Hearing loss and nephrotoxicity are associated with prolonged treatment duration and higher dosage of amikacin and kanamycin. In our Tuberculosis Center, we have employed therapeutic drug monitoring (TDM) targeting pre-set pharmacokinetic/pharmacodynamic (PK/PD) surrogate endpoints in an attempt to maintain efficacy while preventing (oto-)toxicity. To evaluate this strategy, we retrospectively evaluated medical charts of TB patients treated with amikacin or kanamycin in the period 2000 - 2012.Patients with culture-confirmed multi- or extensively drug resistant tuberculosis (MDR/XDR-TB) receiving amikacin or kanamycin as part of their TB treatment for at least 3 days were eligible for inclusion in this retrospective study...
January 9, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28069279/masitinib-for-treatment-of-severely-symptomatic-indolent-systemic-mastocytosis-a-randomised-placebo-controlled-phase-3-study
#6
Olivier Lortholary, Marie Olivia Chandesris, Cristina Bulai Livideanu, Carle Paul, Gérard Guillet, Ewa Jassem, Marek Niedoszytko, Stéphane Barete, Srdan Verstovsek, Clive Grattan, Gandhi Damaj, Danielle Canioni, Sylvie Fraitag, Ludovic Lhermitte, Sophie Georgin Lavialle, Laurent Frenzel, Lawrence B Afrin, Katia Hanssens, Julie Agopian, Raphael Gaillard, Jean-Pierre Kinet, Christian Auclair, Colin Mansfield, Alain Moussy, Patrice Dubreuil, Olivier Hermine
BACKGROUND: Indolent systemic mastocytosis, including the subvariant of smouldering systemic mastocytosis, is a lifelong condition associated with reduced quality of life. Masitinib inhibits KIT and LYN kinases that are involved in indolent systemic mastocytosis pathogenesis. We aimed to assess safety and efficacy of masitinib versus placebo in severely symptomatic patients who were unresponsive to optimal symptomatic treatments. METHODS: In this randomised, double-blind, placebo-controlled, phase 3 study, we enrolled adults (aged 18-75 years) with indolent or smouldering systemic mastocytosis, according to WHO classification or documented mastocytosis based on histological criteria, at 50 centres in 15 countries...
January 6, 2017: Lancet
https://www.readbyqxmd.com/read/28068239/stereotactic-body-radiation-therapy-for-locally-advanced-pancreatic-cancer-a-systematic-review-and-pooled-analysis-of-19-trials
#7
REVIEW
Fausto Petrelli, Tiziana Comito, Antonio Ghidini, Valter Torri, Marta Scorsetti, Sandro Barni
PURPOSE: Although surgery is the standard of care for resectable pancreatic cancer (PC), standard-dose chemoradiation therapy and chemotherapy alone are suitable for patients with unresectable disease. Stereotactic body radiation therapy (SBRT) is an alternative, focused local therapy that delivers high radiation doses within a few fractions to the cancer, sparing the surrounding critical tissue. We performed a systematic review and pooled analysis of published trials to evaluate the efficacy and safety of this emerging treatment modality...
February 1, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28062087/does-an-integrated-boost-increase-acute-toxicity-in-prone-hypofractionated-breast-irradiation-a-randomized-controlled-trial
#8
Leen Paelinck, Akos Gulyban, Ferenc Lakosi, Tom Vercauteren, Werner De Gersem, Bruno Speleers, Christel Monten, Thomas Mulliez, Patrick Berkovic, Annick van Greveling, Frederik Decoster, Philippe Coucke, Wilfried De Neve, Liv Veldeman
BACKGROUND AND PURPOSE: The safety of a simultaneous integrated boost (SIB) in combination with prone hypofractionated whole-breast irradiation (WBI) was investigated. MATERIALS AND METHODS: 167 patients were randomized between WBI with a sequential boost (SeB) or SIB. All patients were treated in prone position to 40.05Gy in 15 fractions to the whole breast. In the control arm, a SeB of 10Gy in 4 fractions (negative surgical margins) or 14.88Gy in 6 fractions (transsection) was prescribed...
January 3, 2017: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/28059869/a-longitudinal-supra-inguinal-fascia-iliaca-compartment-block-reduces-morphine-consumption-after-total-hip-arthroplasty
#9
Matthias Desmet, Kris Vermeylen, Imré Van Herreweghe, Laurence Carlier, Filiep Soetens, Stijn Lambrecht, Kathleen Croes, Hans Pottel, Marc Van de Velde
BACKGROUND AND OBJECTIVES: The role of a fascia iliaca compartment block (FICB) for postoperative analgesia after total hip arthroplasty (THA) remains questionable. High-dose local anesthetics and a proximal injection site may be essential for successful analgesia. High-dose local anesthetics may pose a risk for local anesthetic systemic toxicity. We hypothesized that a high-dose longitudinal supra-inguinal FICB is safe and decreases postoperative morphine consumption after anterior approach THA...
January 3, 2017: Regional Anesthesia and Pain Medicine
https://www.readbyqxmd.com/read/28056569/maternal-side-effects-fetal-neuroprotection-according-to-body-mass-index-after-magnesium-sulfate-in-a-multicenter-randomized-controlled-trial
#10
Gustavo Vilchez, Jing Dai, Moraima Lagos, Robert J Sokol
OBJECTIVE: Evidence supports the need of dose-adjustment of several drugs according to body mass index (BMI) to prevent toxicity in the underweight, and ensure efficacy in obese women. However, for MgSO4 neuroprotection, the effect of BMI on maternal toxicity and fetal neuroprotection is understudied. We analyze the effect of BMI on maternal/infant outcomes after MgSO4. METHODS: Secondary analysis of a clinical trial that studied MgSO4 neuroprotection. Maternal side effects, magnesium cord levels, and offspring cerebral palsy/death were analyzed along BMI strata using ANOVA and chi-square test...
January 6, 2017: Journal of Maternal-fetal & Neonatal Medicine
https://www.readbyqxmd.com/read/28053292/randomized-placebo-controlled-trial-evaluating-the-safety-of-one-year-administration-of-green-tea-catechins
#11
Nagi B Kumar, Julio Pow-Sang, Philippe E Spiess, Jong Park, Raoul Salup, Christopher R Williams, Howard Parnes, Michael J Schell
PURPOSE: Although preclinical, epidemiological and prior clinical trial data suggest that green tea catechins (GTCs) may reduce prostate cancer (PCa) risk, several preclinical studies and case reports have reported liver toxicities and acute gastrointestinal bleeding. Based on these observations, regulatory bodies have required stringent inclusion criteria with frequent, excessive toxicity monitoring and early stopping rules in clinical trials. These requirements have impeded recruitment and retention of subjects in chemoprevention trials and subsequent progress in agent development efforts...
October 25, 2016: Oncotarget
https://www.readbyqxmd.com/read/28042625/efficacy-of-carboplatin-based-preoperative-chemotherapy-for-triple-negative-breast-cancer-a-meta-analysis-of-randomized-controlled-trials
#12
Li-Yang Wang, Hua Xie, Hang Zhou, Wen-Xiu Yao, Xin Zhao, Yi Wang
OBJECTIVES: To evaluate the efficacy and safety of carboplatin-based preoperative chemotherapy in triple-negative breast cancer patients (TNBC). METHODS: PubMed, EMBASE, the Web of Science, the Cochrane Library, major clinical trial registries, and abstract collections from major international meetings were systematically searched for relevant randomized controlled trials. Endpoints included rates of pathologic complete response (pCR), overall response (ORR), breast-conserving surgery (BCS) and toxicity...
January 2017: Saudi Medical Journal
https://www.readbyqxmd.com/read/28040553/efficacy-and-safety-of-ledipasvir-sofosbuvir-with-and-without-ribavirin-in-patients-with-chronic-hepatitis-c-virus-genotype-1-infection-a-meta-analysis
#13
Tingting Tao, Xuehua Jiang, Yuehong Chen, Yiran Song
BACKGROUND: The addition of ribavirin (RBV) to the combination treatment of Ledipasvir (LDV) and Sofosbuvir (SOF) remains controversial in the treatment of hepatitis C virus (HCV) infection. We performed a meta-analysis to assess the efficacy and safety of the LDV-SOF with and without RBV in treating HCV genotype 1 patients. METHOD: The electronical databases of PubMed Medline, EMBASE database, Cochrane Central Register of Controlled Trial (CENTRAL) and ClinicalTrials...
December 28, 2016: International Journal of Infectious Diseases: IJID
https://www.readbyqxmd.com/read/28036140/european-guidelines-s1-on-the-use-of-high-dose-intravenous-immunoglobulin-in-dermatology
#14
Alexander Enk, Eva Hadaschik, Rüdiger Eming, Gerhard Fierlbeck, Lars French, Giampiero Girolomoni, Michael Hertl, Stephen Jolles, Sarolta Karpati, Kerstin Steinbrink, Georg Stingl, Beatrix Volc-Platzer, Detlef Zillikens
BACKGROUND AND OBJECTIVES: Treatment of severe dermatological autoimmune diseases and toxic epidermal necrolysis (TEN) with high-dose intravenous immunoglobulin (IVIg) is a well-established procedure in dermatology. As treatment with IVIg is usually considered for rare clinical entities or severe cases, the use of immunoglobulin is not generally based on data from randomized controlled trials usually required for evidence-based medicine. Since the indications for the use of IVIg are rare, it is unlikely that such studies will be available in the foreseeable future...
December 30, 2016: Journal der Deutschen Dermatologischen Gesellschaft, Journal of the German Society of Dermatology: JDDG
https://www.readbyqxmd.com/read/28027332/opicapone-as-adjunct-to-levodopa-therapy-in-patients-with-parkinson-disease-and-motor-fluctuations-a-randomized-clinical-trial
#15
Andrew J Lees, Joaquim Ferreira, Olivier Rascol, Werner Poewe, José-Francisco Rocha, Michelle McCrory, Patricio Soares-da-Silva
Importance: Catechol O-methyltransferase (COMT) inhibitors are an established treatment for end-of-dose motor fluctuations associated with levodopa therapy in patients with Parkinson disease (PD). Current COMT inhibitors carry a high risk for toxic effects to hepatic cells or show moderate improvement. Opicapone was designed to be effective without the adverse effects. Objective: To evaluate the efficacy and safety of 25- and 50-mg/d dosages of opicapone compared with placebo as adjunct to levodopa therapy in patients with PD experiencing end-of-dose motor fluctuations...
December 27, 2016: JAMA Neurology
https://www.readbyqxmd.com/read/28017254/role-of-vitamin-a-metabolism-in-iih-results-from-the-idiopathic-intracranial-hypertension-treatment-trial
#16
J Libien, M J Kupersmith, W Blaner, M P McDermott, S Gao, Y Liu, J Corbett, M Wall
INTRODUCTION: Vitamin A and its metabolites (called retinoids) have been thought to play a role in the development of idiopathic intracranial hypertension (IIH). The IIH Treatment Trial (IIHTT) showed the efficacy of acetazolamide (ACZ) in improving visual field function, papilledema grade, quality of life and cerebrospinal fluid (CSF) pressure. We postulated that IIH patients would demonstrate elevated measures of vitamin A metabolites in the serum and CSF. METHODS: Comprehensive measures of serum vitamin A and its metabolites were obtained from 96 IIHTT subjects, randomly assigned to treatment with ACZ or placebo, and 25 controls with similar gender, age and body mass index (BMI)...
January 15, 2017: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/28006855/lenalidomide-and-low-dose-dexamethasone-rd-versus-bortezomib-melphalan-prednisone-vmp-in-elderly-newly-diagnosed-multiple-myeloma-patients-a-comparison-of-two-prospective-trials
#17
Massimo Gentile, Valeria Magarotto, Massimo Offidani, Pellegrino Musto, Sara Bringhen, Maria Teresa Petrucci, Francesca Gay, Alessandra Larocca, Giuseppina Uccello, Annamaria Petrungaro, Ernesto Vigna, Rosa Greco, Anna Grazia Recchia, Giovanni Tripepi, Roberto Ria, Francesco Di Raimondo, Antonio Palumbo, And Fortunato Morabito
There are currently no direct head-to-head clinical trials evaluating bortezomib-melphalan-prednisone (VMP) versus lenalidomide and low-dose dexamethasone (Rd). VMP (257 cases) and Rd (222 cases) arms of two randomized phase III trials were employed to assess the treatment influence on outcome in untreated elderly MM patients. Progression free survival (PFS) and overall survival (OS) were the primary and secondary end-points, respectively, and were investigated according to treatments administered over a 60-months follow-up period...
December 22, 2016: American Journal of Hematology
https://www.readbyqxmd.com/read/28002808/sublobar-resection-is-associated-with-improved-outcomes-over-radiotherapy-in-the-management-of-high-risk-elderly-patients-with-stage-i-non-small-cell-lung-cancer-a-systematic-review-and-meta-analysis
#18
Huan-Huan Wang, Chun-Ze Zhang, Bai-Lin Zhang, Jie Chen, Xian-Liang Zeng, Lei Deng, Mao-Bin Meng
BACKGROUND AND AIM: A matched-pair comparison was performed to compare the efficacy and safety of sublobar resection versus radiotherapy for high-risk elderly patients with Stage I non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: We searched the Cochrane Library, MEDLINE, CENTRAL, EMBASE and manual searches. The meta-analysis was performed to compare overall survival, pattern of failure, and toxicity among the homogeneous studies. Subdivided analyses were also performed...
December 17, 2016: Oncotarget
https://www.readbyqxmd.com/read/27998965/does-severe-toxicity-affect-global-quality-of-life-in-patients-with-metastatic-colorectal-cancer-during-palliative-systemic-treatment-a-systematic-review
#19
REVIEW
C S E W Schuurhuizen, A M J Braamse, I R H M Konings, M A G Sprangers, J C F Ket, J Dekker, H M W Verheul
BACKGROUND: New palliative systemic treatment regimens in patients with metastatic colorectal cancer (mCRC) have significantly improved overall survival and prognosis. These treatment regimens are often accompanied by increased toxicity, which may impair patients' quality of life (QOL). We systematically reviewed whether severe toxicity affects global QOL in patients with mCRC receiving palliative systemic treatment in recent published randomized controlled trials (RCTs). MATERIALS AND METHODS: Phase III RCTs evaluating palliative systemic treatments in patients with mCRC and published between 2004 and 2016 were considered...
December 19, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/27998964/phase-2-placebo-controlled-double-blind-trial-of-dasatinib-added-to-gemcitabine-for-patients-with-locally-advanced-pancreatic-cancer
#20
T R J Evans, E Van Cutsem, M J Moore, I S Bazin, A Rosemurgy, G Bodoky, G Deplanque, M Harrison, B Melichar, D Pezet, A Elekes, E Rock, C Lin, L Strauss, P J O'Dwyer
BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) has a high mortality rate with limited treatment options. Gemcitabine provides a marginal survival benefit for patients with advanced PDAC. Dasatinib is a competitive inhibitor of Src kinase, which is overexpressed in PDAC tumors. Dasatinib and gemcitabine were combined in a phase 1 clinical trial where stable disease was achieved in 2 of 8 patients with gemcitabine-refractory PDAC. PATIENTS AND METHODS: This placebo-controlled, randomized, double-blind, phase II study compared the combination of gemcitabine plus dasatinib to gemcitabine plus placebo in patients with locally advanced, non-metastatic PDAC...
December 19, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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