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https://www.readbyqxmd.com/read/28090524/the-samukeppra-study-in-prehospital-status-epilepticus-lessons-for-future-study
#1
COMMENT
Andrew C Schomer, Jaideep Kapur
In the Lancet Neurology article "Prehospital treatment with levetiracetam plus clonazepam or placebo plus clonazepam in status epilepticus (SAMUKeppra): a randomised, double-blind, phase 3 trial" the authors conducted a prehospital, randomized controlled study to determine which treatment is more effective for status epilepticus (SE): benzodiazepine alone, or in combination with levetiracetam (LEV). Although the study had negative results, several aspects of the trial design likely masked any added effect that LEV may have had in controlling SE, including: higher doses of benzodiazepines, lower thresholds for determining cessation of SE, and a smaller sample size...
December 2016: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28089967/clinical-orofacial-examination-in-juvenile-idiopathic-arthritis-international-consensus-based-recommendations-for-monitoring-patients-in-clinical-practice-and-research-studies
#2
Peter Stoustrup, Marinka Twilt, Lynn Spiegel, Kasper Dahl Kristensen, Bernd Koos, Thomas Klit Pedersen, Annelise Küseler, Randy Q Cron, Shelly Abramowicz, Carlalberta Verna, Timo Peltomäki, Per Alstergren, Ross Petty, Sarah Ringold, Sven Erik Nørholt, Rotraud K Saurenmann, Troels Herlin
OBJECTIVE: To develop international consensus-based recommendations for the orofacial examination of patients with juvenile idiopathic arthritis (JIA), for use in clinical practice and research. METHODS: Using a sequential phased approach, a multidisciplinary task force developed and evaluated a set of recommendations for the orofacial examination of patients with JIA. Phase 1: A Delphi survey was conducted among 40 expert physicians and dentists with the aim of identifying and ranking the importance of items for inclusion...
January 15, 2017: Journal of Rheumatology
https://www.readbyqxmd.com/read/28088906/epratuzumab-and-blinatumomab-as-therapeutic-antibodies-for-treatment-of-pediatric-acute-lymphoblastic-leukemia-current-status-and-future-perspectives
#3
Raffaella Franca, Diego Favretto, Marilena Granzotto, Giuliana Decorti, Marco Rabusin, Gabriele Stocco
BACKGROUND: More than 85% of children affected by acute lymphoblastic leukemia (ALL) are successfully treated; however relapse remains a remarkable clinical concern, with 50-60% of relapsing patients facing a fatal outcome. Management of relapsed patients includes standardized intensive risk-adapted regimens based on conventional drugs, and hematopoietic stem cells transplantation for patients with unfavourable features. Biological drugs, in particular the monoclonal antibody epratuzumab and the bi-functional recombinant single chain peptide blinatumomab, have been recently recognized as novel potential agents to be integrated in salvage ALL therapy to further improve rescue outcome...
January 12, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28088768/in-vitro-activity-of-ceftazidime-avibactam-against-urinary-isolates-from-patients-in-a-phase-3-clinical-trial-programme-for-the-treatment-of-complicated-urinary-tract-infections
#4
Gregory G Stone, Patricia A Bradford, Katrina Yates, Paul Newell
OBJECTIVES: To evaluate the in vitro activity of ceftazidime/avibactam relative to comparator agents against Gram-negative isolates from a Phase 3 clinical trial programme for complicated urinary tract infections (RECAPTURE). METHODS: The in vitro activity of ceftazidime/avibactam was evaluated against 840 Gram-negative pathogens isolated at baseline from 1033 randomized patients in two pivotal Phase 3 clinical trials for the treatment of complicated urinary tract infections...
January 14, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28088174/feasibility-and-safety-of-dilatational-tracheotomy-using-the-rigid-endoscope-a-multicenter-study
#5
Andreas Nowak, Peter Kern, Sven Koscielny, Taras I Usichenko, Klaus Hahnenkamp, Markus Jungehülsing, Matthias Tittel, Jens Oeken, Eckart Klemm
BACKGROUND: Fiberoptic tracheo-bronchoscopy is the most commonly used procedure for percutaneous dilational tracheotomy (PDT). However, PDT can be associated with major complications, including death. Furthermore it is unclear, whether the tracheal ring fractures may contribute to the development of tracheal stenosis after PDT nor whether tracheal ring fractures can be prevented by using a rigid endoscope for this procedure. The purpose of this study was to evaluate the feasibility of and the incidence of complications for PDT using the rigid tracheotomy endoscope (TED)...
January 14, 2017: BMC Anesthesiology
https://www.readbyqxmd.com/read/28087807/field-validation-of-the-los-angeles-motor-scale-as-a-tool-for-paramedic-assessment-of-stroke-severity
#6
Joon-Tae Kim, Pil-Wook Chung, Sidney Starkman, Nerses Sanossian, Samuel J Stratton, Marc Eckstein, Frank D Pratt, Robin Conwit, David S Liebeskind, Latisha Sharma, Lucas Restrepo, May-Kim Tenser, Miguel Valdes-Sueiras, Jeffrey Gornbein, Scott Hamilton, Jeffrey L Saver
BACKGROUND AND PURPOSE: The Los Angeles Motor Scale (LAMS) is a 3-item, 0- to 10-point motor stroke-deficit scale developed for prehospital use. We assessed the convergent, divergent, and predictive validity of the LAMS when performed by paramedics in the field at multiple sites in a large and diverse geographic region. METHODS: We analyzed early assessment and outcome data prospectively gathered in the FAST-MAG trial (Field Administration of Stroke Therapy-Magnesium phase 3) among patients with acute cerebrovascular disease (cerebral ischemia and intracranial hemorrhage) within 2 hours of onset, transported by 315 ambulances to 60 receiving hospitals...
January 13, 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28081304/comparison-of-an-ac-taxane-versus-ac-free-regimen-and-paclitaxel-versus-docetaxel-in-patients-with-lymph-node-positive-breast-cancer-final-results-of-the-national-surgical-adjuvant-study-of-breast-cancer-02-trial-a-randomized-comparative-phase-3-study
#7
Toru Watanabe, Masaru Kuranami, Kenichi Inoue, Norikazu Masuda, Kenjiro Aogi, Shinji Ohno, Hiroji Iwata, Hirofumi Mukai, Yukari Uemura, Yasuo Ohashi
BACKGROUND: In postoperative patients with breast cancer, the combination of an anthracycline and cyclophosphamide (AC) followed by a taxane is a standard regimen. In the current study, the authors examined whether AC could be safely omitted, and compared the effectiveness of paclitaxel versus docetaxel. METHODS: Female postoperative patients with axillary lymph node-positive breast cancer were eligible for enrollment in this phase 3, open-label, randomized controlled trial at 84 centers in Japan...
January 12, 2017: Cancer
https://www.readbyqxmd.com/read/28079500/efficacy-and-safety-of-tofacitinib-in-older-and-younger-patients-with-rheumatoid-arthritis
#8
Jeffrey R Curtis, Hendrik Schulze-Koops, Liza Takiya, Charles A Mebus, Ketti K Terry, Pinaki Biswas, Thomas V Jones
OBJECTIVES: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the efficacy and safety of tofacitinib 5 or 10 mg twice daily (BID), in patients with moderate to severe RA, aged ≥65 and <65 years. METHODS: Data were pooled from five Phase 3 trials and, separately, from two open-label long-term extension (LTE) studies (data cut-off April, 2012). Patients received tofacitinib, or placebo (Phase 3 only), with/without conventional synthetic DMARDs (mainly methotrexate)...
January 4, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28078634/natalizumab-for-achieving-relapse-free-t1-gadolinium-enhancing-lesion-free-and-t2-lesion-free-status-in-japanese-multiple-sclerosis-patients-a-phase-2-trial-subanalysis
#9
Takahiko Saida, Jun-Ichi Kira, Shuji Kishida, Takashi Yamamura, Nobuhisa Ohtsuka, Qunming Dong, J T Tibung
INTRODUCTION: In a phase 2 trial of natalizumab in Japanese patients with relapsing-remitting multiple sclerosis (RRMS), treatment-related changes in relapses, brain lesions, and disability worsening were found to be comparable with those observed in the phase 3 studies of natalizumab in primarily non-Asian RRMS patients. METHODS: This subanalysis of the placebo-controlled phase 2 trial of natalizumab in Japanese RRMS patients (n = 94) evaluated the effects of natalizumab versus placebo on the proportion of patients who achieved relapse-free, T1 gadolinium-enhancing (Gd+) lesion-free, and new/newly enlarged T2 lesion-free status, defined as "no evidence of inflammatory disease activity" (NEDA)-like status, after 24 weeks of treatment...
January 11, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/28077675/post-hoc-assessment-of-the-immunogenicity-of-bioengineered-factor-viia-demonstrates-the-use-of-preclinical-tools
#10
Kasper Lamberth, Stine Louise Reedtz-Runge, Jonathan Simon, Ksenia Klementyeva, Gouri Shankar Pandey, Søren Berg Padkjær, Véronique Pascal, Ileana R León, Charlotte Nini Gudme, Søren Buus, Zuben E Sauna
Immunogenicity is an important consideration in the licensure of a therapeutic protein because the development of neutralizing anti-drug antibodies (ADAs) can affect both safety and efficacy. Neoantigens introduced by bioengineering of a protein drug are a particular cause for concern. The development of a bioengineered recombinant factor VIIa (rFVIIa) analog was discontinued after phase 3 trials because of the development of ADAs. The unmodified parent molecule (rFVIIa), on the other hand, has been successfully used as a drug for more than two decades with no reports of immunogenicity in congenital hemophilia patients with inhibitors...
January 11, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/28077584/2-year-efficacy-immunogenicity-and-safety-of-vigoo-enterovirus-71-vaccine-in-healthy-chinese-children-a-randomized-open-label-study
#11
Mingwei Wei, Fanyue Meng, Shiyuan Wang, Jingxin Li, Yuntao Zhang, Qunying Mao, Yuemei Hu, Pei Liu, Nianmin Shi, Hong Tao, Kai Chu, Yuxiao Wang, Zhenglun Liang, Xiuling Li, Fengcai Zhu
BACKGROUND:  This study evaluated the 2-year efficacy, immunogenicity, and safety of the Vigoo enterovirus 71 (EV71) vaccine. METHOD:  In an initial phase 3 study, we randomly assigned healthy infants and children aged 6-35 months (ratio, 1:1) to receive 2 doses of either EV71 vaccine (5120 participants) or placebo (5125 participants) at days 0 and 28, and followed them for 12 months after vaccination. In this extended follow-up study, we continued to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine for up to 2 years...
January 1, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28076854/open-angle-glaucoma-drug-development-pipeline-during-the-last-20-years-1995-2015
#12
André Vicente, Sylvie Prud'homme, Joana Ferreira, Luís Abegão Pinto, Ingeborg Stalmans
OBJECTIVES: To analyse drug development for open-angle glaucoma during the last 20 years. METHODS: Research was performed by referring to clinical trials registered at the International Clinical Trials Registry Platform (ICTRP). A search for the condition "open-angle glaucoma" with the intervention "drug" was performed. We included trials registered from 01/01/1995 to 01/01/2015, only involving studies in phases 1, 2, and 3. Only studies resorting to novel treatment strategies (either novel drugs or yet-untested fixed associations of approved medication) were considered...
January 12, 2017: Ophthalmic Research
https://www.readbyqxmd.com/read/28076709/phase-3-trial-of-177-lu-dotatate-for-midgut-neuroendocrine-tumors
#13
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/28076695/deacetylase-inhibitors-an-advance-in-myeloma-therapy
#14
Jacob P Laubach, Jesus F San-Miguel, Vania Hungria, Jian Hou, Philippe Moreau, Sagar Lonial, Jae Hoon Lee, Hermann Einsele, Melissa Alsina, Paul G Richardson
A significant unmet need exists in patients with relapsed or refractory multiple myeloma (MM), which remains an incurable disease despite recent advances in the field. One such development was the use of deacetylase inhibitors (DACi), which exert unique antimyeloma effects through targeting of epigenetic and protein metabolism pathways. The pan-DACi panobinostat was recently approved in combination with bortezomib and dexamethasone for use in patients with relapsed or relapsed and refractory MM. Results of a phase 3 trial showed that the panobinostat-containing regimen improved the overall response rate and progression-free survival...
January 11, 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/28076335/infrequent-development-of-drug-resistance-in-hiv-1-infected-treatment-naive-subjects-after-96-weeks-of-treatment-with-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-or-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate
#15
Nicolas Margot, Stephanie Cox, Moupali Das, Scott McCallister, Michael D Miller, Christian Callebaut
BACKGROUND: Tenofovir alafenamide (TAF) is a novel prodrug of the nucleotide RT inhibitor (NtRTI) tenofovir (TFV) that loads lymphocytes with TFV-diphosphate more efficiently than tenofovir disoproxil fumarate (TDF). The single-tablet regimen (STR) composed of elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF) has demonstrated non-inferiority to the STR of E/C/F/TDF in clinical studies, with high proportions of subjects achieving HIV-1 RNA <50 copies/mL at week 48, and maintained through week 96...
January 11, 2017: Antiviral Therapy
https://www.readbyqxmd.com/read/28075214/intralipid-vehicle-does-not-interfere-with-the-efficacy-of-progesterone-in-attenuating-edema-following-tbi
#16
Bushra Wali, Donald Stein, Iqbal Sayeed
The recent disappointing results of Phase 3 trials for progesterone (PROG) in traumatic brain injury (TBI) have triggered speculation about reasons for the negative outcomes. One confounding factor may have been the vehicle used to administer PROG. Virtually all of the many preclinical experiments informing the clinical trials and reporting beneficial PROG effects used more soluble 2-hydroxypropyl-b-cyclodextrin (HBC) as a vehicle given intraperitoneally or subcutaneously rather than a lipid formulation given intravenously (i...
January 11, 2017: Journal of Neurotrauma
https://www.readbyqxmd.com/read/28075066/efficacy-and-safety-of-fixed-dose-combination-therapy-alogliptin-plus-metformin-in-asian-patients-with-type-2-diabetes-a-phase-3-trial
#17
Linong Ji, Ling Li, Jian Kuang, Tao Yang, Dong-Jun Kim, Azidah Abdul Kadir, Chien-Ning Huang, Douglas Lee
This study evaluated the efficacy and safety of 26 weeks of twice-daily (BID) alogliptin + metformin fixed-dose combination (FDC) therapy in Asian patients with type 2 diabetes. Patients aged 18 - 75 years with hemoglobin A1c (HbA1c) 7.5 - 10.0% after ≥2 months of diet and exercise and a 4-week placebo run-in were enrolled. Eligible patients were randomized (1:1:1:1) to placebo, alogliptin 12.5 mg BID, metformin 500 mg BID, or alogliptin 12.5 mg plus metformin 500 mg FDC BID. The primary endpoint was change in HbA1c from baseline to end of treatment (Week 26)...
January 11, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28075064/efficacy-of-nebivolol-valsartan-single-pill-combination-in-obese-and-nonobese-patients-with-hypertension
#18
Christian W Mende, Thomas D Giles, David B Bharucha, William G Ferguson, Madhuja Mallick, Mehul D Patel
Antihypertensive efficacy of single-pill combinations (SPCs) consisting of a β1 -selective adrenergic blocker with vasodilatory properties via β3 -agonism (nebivolol) and an angiotensin II receptor blocker (valsartan) was demonstrated in an 8-week phase 3 trial (NCT01508026). In this post hoc analysis, seated blood pressure, heart rate, 24-hour ambulatory blood pressure monitoring, plasma aldosterone, estimated glomerular filtration rate, and safety measures were assessed in obese (body mass index >32 kg/m(2) ; n=1823) and nonobese (body mass index <27 kg/m(2) ; n=847) adults with hypertension (stage I or II) treated with nebivolol-valsartan SPCs, nebivolol or valsartan monotherapy, or placebo...
January 11, 2017: Journal of Clinical Hypertension
https://www.readbyqxmd.com/read/28074556/qt-interval-shortening-with-isavuconazole-in-vitro-and-in-vivo-effects-on-cardiac-repolarization
#19
J Keirns, A Desai, D Kowalski, C Lademacher, S Mujais, B Parker, M J Schneidkraut, R Townsend, T Wojtkowski, T Yamazaki, M Yen, P R Kowey
Effects of isavuconazole (active moiety of isavuconazonium sulfate) on cardiac ion channels in vitro and cardiac repolarization clinically were assessed in a Phase 1, randomized, double-blind study in healthy individuals who received isavuconazole (after 2-day loading dose), at therapeutic or supratherapeutic doses daily for 11 days, moxifloxacin (400 mg QD), or placebo. A post-hoc analysis of the Phase 3 SECURE trial assessed effects on cardiac safety. L-type Ca(2+) channels were most sensitive to inhibition by isavuconazole...
January 11, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28073686/interventions-to-improve-dissemination-and-implementation-of-hepatitis-b-vaccination-in-patients-with-diabetes
#20
Thomas Matta, Katherine O'Neal, Jeremy Johnson, Sandra Carter, Michelle Lamb, Lourdes Planas
OBJECTIVE: The purpose of this study was to assess provider awareness of routine vaccinations recommended for patients with diabetes and to determine whether pharmacist-led interventions are associated with increased provider implementation of recommendations for hepatitis B vaccination. METHODS: This study was conducted in 3 phases at 2 outpatient clinics affiliated with an academic institution. In phase 1, adults with diabetes who visited the clinics between January and November 2012 and who were eligible for the hepatitis B vaccine were identified...
January 7, 2017: Journal of the American Pharmacists Association: JAPhA
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