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https://www.readbyqxmd.com/read/29146683/pcsk9-variants-ldl-cholesterol-and-neurocognitive-impairment-the-reasons-for-geographic-and-racial-differences-in-stroke-regards-study
#1
Matthew T Mefford, Robert S Rosenson, Mary Cushman, Michael E Farkouh, Leslie A McClure, Virginia G Wadley, Marguerite R Irvin, Vera A Bittner, Monika M Safford, Ransi Somaratne, Keri L Monda, Paul Muntner, Emily B Levitan
Background -Despite concerns about adverse neurocognitive events raised by prior trials, pharmacologic PCSK9 inhibition was not associated with neurocognitive effects in a recent phase 3 randomized trial. PCSK9 loss-of-function (LOF) variants that result in life-long exposure to low LDL-C can provide information on the potential long-term effects of low LDL-C on neurocognitive impairment and decline. Methods -We investigated the association between PCSK9 LOF variants and neurocognitive impairment and decline among African-American REasons for Geographic and Racial Differences in Stroke (REGARDS) study participants with (n=241) and without (n=10,454) C697X or Y142X LOF variants...
November 16, 2017: Circulation
https://www.readbyqxmd.com/read/29146401/neratinib-after-trastuzumab-based-adjuvant-therapy-in-her2-positive-breast-cancer-extenet-5-year-analysis-of-a-randomised-double-blind-placebo-controlled-phase-3-trial
#2
Miguel Martin, Frankie A Holmes, Bent Ejlertsen, Suzette Delaloge, Beverly Moy, Hiroji Iwata, Gunter von Minckwitz, Stephen K L Chia, Janine Mansi, Carlos H Barrios, Michael Gnant, Zorica Tomašević, Neelima Denduluri, Robert Šeparović, Erhan Gokmen, Anna Bashford, Manuel Ruiz Borrego, Sung-Bae Kim, Erik Hugger Jakobsen, Audrone Ciceniene, Kenichi Inoue, Friedrich Overkamp, Joan B Heijns, Anne C Armstrong, John S Link, Anil Abraham Joy, Richard Bryce, Alvin Wong, Susan Moran, Bin Yao, Feng Xu, Alan Auerbach, Marc Buyse, Arlene Chan
BACKGROUND: ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings. METHODS: In this ongoing randomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (≥20 years in Japan) with stage 1-3c (modified to stage 2-3c in February, 2010) operable breast cancer, who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab with no evidence of disease recurrence or metastatic disease at study entry...
November 13, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29144061/saxagliptin-add-on-therapy-in-chinese-patients-with-type-2-diabetes-inadequately-controlled-by-insulin-with-or-without-metformin-results-from-the-super-study-a-randomized-double-blind-placebo-controlled-trial
#3
Yingli Chen, Xiaomin Liu, Quanmin Li, Jianhua Ma, Xiaofeng Lv, Lixin Guo, Changjiang Wang, Yongquan Shi, Yanbing Li, Eva Johnsson, Mei Wang, June Zhao, Linong Ji
This prospective, multicentre, phase 3 study (NCT02104804) evaluated the efficacy and safety of saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin ± metformin. Patients with glycated haemoglobin (HbA1c) 7.5%-10.5% and fasting plasma glucose (FPG) <270 mg/dL on stable insulin therapy (20-150 U/day) were randomized (1:1) to saxagliptin 5 mg once daily (N = 232) or placebo (N = 230) for 24 weeks, stratified by metformin use. The primary efficacy measure was change in HbA1c...
November 16, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29142515/efficacy-and-safety-of-ustekinumab-in-japanese-patients-with-moderately-to-severely-active-crohn-s-disease-a-subpopulation-analysis-of-phase-3-induction-and-maintenance-studies
#4
Toshifumi Hibi, Yuya Imai, Yoko Murata, Nobuko Matsushima, Richuan Zheng, Christopher Gasink
Background/Aims: Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to severely active Crohn's disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall population. Methods: Overall, patients in UNITI-1 (Japan, n=56; failed response to tumor necrosis factor antagonist) and UNITI-2 (Japan, n=26; failed response to prior conventional therapy) were randomized to placebo or ustekinumab intravenous induction (130 mg or ~6 mg/kg) at week 0...
October 2017: Intestinal Research
https://www.readbyqxmd.com/read/29141665/matrix-metalloproteinase-3-and-the-7-joint-ultrasound-score-in-the-assessment-of-disease-activity-and-therapeutic-efficacy-in-patients-with-moderate-to-severe-rheumatoid-arthritis
#5
Ling Zhou, Geng Wang, Xin Liu, Jing Song, Ling Chen, Huji Xu
BACKGROUND: This study aimed to investigate the reliability and validity of serum matrix metalloproteinase-3 (MMP-3) levels and articular ultrasound (US) scores in assessing disease activity and therapeutic response in rheumatoid arthritis (RA) patients. METHODS: A total of 151 RA patients were enrolled, of whom 22 were treated with certolizumab pegol (Cimzia, CZP). The RA patients were divided into the following four subgroups according to their disease activity score in 28 joints (DAS28): stable, mild activity, moderate activity, and high activity...
November 15, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/29141611/are-paraspinous-intramuscular-injections-of-botulinum-toxin-a-bont-a-efficient-in-the-treatment-of-chronic-low-back-pain-a-randomised-double-blinded-crossover-trial
#6
Mélanie Cogné, Hervé Petit, Alexandre Creuzé, Dominique Liguoro, Mathieu de Seze
BACKGROUND: Treatment for patients with chronic low-back pain (LBP) is a public health issue. Intramuscular injections of botulinum toxin A (BoNT-A) have shown an analgesic effect on LBP in two previous randomized controlled studies. The objective of the study was to verify the efficacy of paravertebral injections of BoNT-A in patients with LBP. METHODS: Patients were included in this phase 3 randomized double-blinded trial comparing the efficacy of BoNT-A versus placebo in a crossover study on LBP...
November 15, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/29140839/effectiveness-and-safety-of-a-thermosensitive-hydrogel-cultured-epidermal-allograft-for-burns
#7
Jaechul Yoon, Hyeong-Tae Yang, Haejun Yim, Yong-Suk Cho, Dohern Kym, Jun Hur, Wook Chun, Jong-Wook Lee, Chunjae Yoon
OBJECTIVE: To retest the safety and effectiveness of a thermosensitive hydrogel-type cultured epithelial allograft (KeraHeal-Allo; MCTT, Seoul, South Korea) and identify the subjective experience of patients and doctors with this product. DESIGN AND SETTING: Prospective interventional phase 3 study in 3 burn centers near Seoul, South Korea. PATIENTS: Thirty-three patients with deep second-degree burns larger than 200 cm (for intervention and control sites of 100 cm each) were enrolled...
December 2017: Advances in Skin & Wound Care
https://www.readbyqxmd.com/read/29140127/proprioceptive-training-for-the-prevention-of-ankle-sprains-an-evidence-based-review
#8
Matthew J Rivera, Zachary K Winkelmann, Cameron J Powden, Kenneth E Games
Reference:  Schiftan GS, Ross LA, Hahne AJ. The effectiveness of proprioceptive training in preventing ankle sprains in sporting populations: a systematic review and meta-analysis. J Sci Med Sport. 2015;18(3):238-244. CLINICAL QUESTION:   Does the use of proprioceptive training as a sole intervention decrease the incidence of initial or recurrent ankle sprains in the athletic population? DATA SOURCES:   The authors completed a comprehensive literature search of MEDLINE, CINAHL, SPORTDiscus, and Physiotherapy Evidence Database (PEDro) from inception to October 2013...
November 15, 2017: Journal of Athletic Training
https://www.readbyqxmd.com/read/29139135/phase-1-study-of-quizartinib-in-combination-with-induction-and-consolidation-chemotherapy-in-patients-with-newly-diagnosed-acute-myeloid-leukemia
#9
Jessica K Altman, James M Foran, Keith W Pratz, Denise Trone, Jorge E Cortes, Martin S Tallman
Novel therapies have potential to improve outcomes in patients with acute myeloid leukemia (AML) harboring FLT3-ITD mutations that have high risk of relapse and poor survival following standard of care (SOC) cytarabine/anthracycline-based induction/consolidation chemotherapy. Quizartinib is a selective and highly potent FLT3 inhibitor that has shown strong single-agent activity in relapsed or refractory (R/R) AML. This phase 1, open-label, sequential group dose-escalation trial (NCT 01390337) is the first evaluating safety and tolerability of quizartinib in combination with SOC chemotherapy in newly diagnosed AML (ndAML)...
November 15, 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/29138986/secukinumab-in-active-rheumatoid-arthritis-after-anti-tnf%C3%AE-therapy-a-randomized-double-blind-placebo-controlled-phase-3-study
#10
Hasan Tahir, Atul Deodhar, Mark Genovese, Tsutomu Takeuchi, Jacob Aelion, Filip Van den Bosch, Sibylle Haemmerle, Hanno B Richards
INTRODUCTION: 'REASSURE' (NCT01377012), a phase 3 study, evaluated the efficacy and safety of secukinumab in patients with active rheumatoid arthritis (RA) who had an inadequate response to, or intolerance of, tumor necrosis factor inhibitors (TNF-inhibitors). METHODS: A total of 637 patients were randomized (1:1:1) to receive intravenous secukinumab 10 mg/kg (baseline, weeks 2 and 4) followed by subcutaneous secukinumab 150 mg or 75 mg every 4 weeks (starting from week 8) or placebo at the same dosing schedule...
November 14, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29137681/influence-of-tourniquet-use-in-primary-total-knee-arthroplasty-with-drainage-a-prospective-randomised-controlled-trial
#11
Kai Zhou, Tingxian Ling, Haoyang Wang, Zongke Zhou, Bin Shen, Jing Yang, Pengde Kang, Fuxing Pei
BACKGROUND: We aimed to compare the effect of tourniquet use or lack of it on recovery following uncomplicated primary total knee arthroplasty (TKA). METHODS: In a prospective randomised double-blinded study, 150 patients undergoing primary TKA were assigned to either a tourniquet or non-tourniquet group. At the early phase, 3 and 6 months after surgery, an independent observer assessed the primary outcome measure (i.e. total blood loss) and secondary outcome measures (i...
November 14, 2017: Journal of Orthopaedic Surgery and Research
https://www.readbyqxmd.com/read/29136653/drlumi-an-open-source-package-to-manage-data-calibrate-and-conduct-quality-control-of-multiplex-bead-based-immunoassays-data-analysis
#12
Hector Sanz, John J Aponte, Jaroslaw Harezlak, Yan Dong, Aintzane Ayestaran, Augusto Nhabomba, Maxmillian Mpina, Obiang Régis Maurin, Núria Díez-Padrisa, Ruth Aguilar, Gemma Moncunill, Agnandij Selidji Todagbe, Claudia Daubenberger, Carlota Dobaño, Clarissa Valim
Multiplex bead-based immunoassays are used to measure concentrations of several analytes simultaneously. These assays include control standard curves (SC) to reduce between-plate variability and normalize quantitation of analytes of biological samples. Suboptimal calibration might result in large random error and decreased number of samples with analyte concentrations within the limits of quantification. Suboptimal calibration may be a consequence of poor fitness of the functions used for the SC, the treatment of the background noise and the method used to estimate the limits of quantification...
2017: PloS One
https://www.readbyqxmd.com/read/29136445/effect-of-varying-doses-of-epicutaneous-immunotherapy-vs-placebo-on-reaction-to-peanut-protein-exposure-among-patients-with-peanut-sensitivity-a-randomized-clinical-trial
#13
Hugh A Sampson, Wayne G Shreffler, William H Yang, Gordon L Sussman, Terri F Brown-Whitehorn, Kari C Nadeau, Amarjit S Cheema, Stephanie A Leonard, Jacqueline A Pongracic, Christine Sauvage-Delebarre, Amal H Assa'ad, Frederic de Blay, J Andrew Bird, Stephen A Tilles, Franck Boralevi, Thierry Bourrier, Jacques Hébert, Todd D Green, Roy Gerth van Wijk, André C Knulst, Gisèle Kanny, Lynda C Schneider, Marek L Kowalski, Christophe Dupont
Importance: Epicutaneous immunotherapy may have potential for treating peanut allergy but has been assessed only in preclinical and early human trials. Objective: To determine the optimal dose, adverse events (AEs), and efficacy of a peanut patch for peanut allergy treatment. Design, Setting, and Participants: Phase 2b double-blind, placebo-controlled, dose-ranging trial of a peanut patch in peanut-allergic patients (6-55 years) from 22 centers, with a 2-year, open-label extension (July 31, 2012-July 31, 2014; extension completed September 29, 2016)...
November 14, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/29136060/clinical-trial-designs-for-topical-antifungal-treatments-of-onychomycosis-and-implications-on-clinical-practice
#14
Phoebe Rich, Tracey C Vlahovic, Warren S Joseph, Lee T Zane, Steve B Hall, Nicole Gellings Lowe, Chris G Adigun
There currently are 3 topical agents approved by the US Food and Drug Administration (FDA) to treat onychomycosis: tavaborole, efinaconazole, and ciclopirox. The phase 3 clinical trial designs for these treatments and their notable differences make it difficult for clinicians to interpret the data into clinical practice. For example, the primary end point predominantly used to assess efficacy in all the trials is complete cure, defined as no involvement of the nail plus mycologic cure; also, a notable number of patients fail to achieve a complete cure despite clear improvement in the nail...
October 2017: Cutis; Cutaneous Medicine for the Practitioner
https://www.readbyqxmd.com/read/29135397/electrolytes-imbalance-caused-by-amikacin-in-patients-receiving-multi-drug-resistance-tuberculosis-treatment-at-hazara-region-kpk-pakistan
#15
Faheem Jan, Mukhtiar Hassan, Naveed Muhammad, Shahid Wali, Hafiz Sajid Akbar, Qazi Mashhood Atta, Farzana Gul
Introduction: Multi drug resistance-tuberculosis (MDR-TB) is considered amongst one of the fatal medical and public health issue. Greater frequency of adverse reactions has been observed using 2nd line antituberculosis drugs, which rises the rate of morbidity. Hypokalemia and hyponatremia are common in patients receiving MDR-TB treatment. Materials and Methods: This study was aimed to assess the effect of amikacin as multidrug resistance tuberculosis treatment on serum sodium and potassium level...
September 2017: Tüberküloz Ve Toraks
https://www.readbyqxmd.com/read/29134891/efficacy-and-safety-of-baricitinib-in-japanese-patients-with-rheumatoid-arthritis-subgroup-analyses-of-four-multinational-phase-3-randomized-trials
#16
Yoshiya Tanaka, Tatsuya Atsumi, Koichi Amano, Masayoshi Harigai, Taeko Ishii, Osamu Kawaguchi, Terence P Rooney, Naotsugu Akashi, Tsutomu Takeuchi
OBJECTIVES: To evaluate efficacy/safety of baricitinib for rheumatoid arthritis (RA) in Japanese subpopulations from four phase 3 studies, and assess whether results in these subpopulations are consistent with the overall study populations. METHODS: Subgroup analyses (394 patients) of four phase 3 randomized controlled trials: RA-BEGIN [no or limited treatment with disease-modifying antirheumatic drugs (DMARDs)], RA-BEAM [inadequate response (IR) to methotrexate], RA-BUILD [IR to conventional synthetic DMARDs (csDMARDs)], and RA-BEACON (IR to tumor necrosis factor inhibitors receiving csDMARDs)...
November 14, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/29133600/availability-and-use-of-shared-data-from-cardiometabolic-clinical-trials
#17
Muthiah Vaduganathan, Amulya Nagarur, Arman Qamar, Ravi B Patel, Ann Marie Navar, Eric D Peterson, Deepak L Bhatt, Gregg C Fonarow, Clyde W Yancy, Javed Butler
BACKGROUND : Sharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials. METHODS : We extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies. RESULTS : From January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%)...
November 13, 2017: Circulation
https://www.readbyqxmd.com/read/29133570/activity-of-simulated-human-dosage-regimens-of-meropenem-and-vaborbactam-against-carbapenem-resistant-enterobacteriaceae-in-an-in-vitro-hollow-fiber-model
#18
Mojgan Sabet, Ziad Tarazi, Debora Rubio-Aparicio, Thomas G Nolan, Jonathan Parkinson, Olga Lomovskaya, Michael N Dudley, David C Griffith
The objective of these studies was to evaluate the exposures of meropenem and vaborbactam that would produce antibacterial activity and prevent resistance development in carbapenem-resistant, Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae strains when tested at an inocula of 10(8) CFU/mL. Thirteen K. pneumoniae isolates, three Enterobacter cloacae isolates, and one Escherichia coli isolate were examined in an in vitro hollow fiber model over 32 hours. Simulated dosage regimens of meropenem 1-2 g with vaborbactam 1-2 g, meropenem administered every 8 hours by 3 hour infusion based on Phase 1 or Phase 3 patient pharmacokinetic data were studied in the model...
November 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29133566/use-of-pharmacokinetic-and-pharmacodynamic-analyses-to-determine-the-optimal-fixed-dosing-regimen-of-iclaprim-for-treatment-of-serious-gram-positive-infections
#19
Thomas Lodise, John Bosso, Colleen Kelly, Paul J Williams, James R Lane, David B Huang
Iclaprim is a bacterial dihydrofolate reductase inhibitor that is currently being evaluated in two Phase 3 trials for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Prior animal infection models studies suggest that the pharmacokinetic and pharmacodynamics (PK/PD) drivers for efficacy are area under the curve from 0-24 hours at steady state (AUC0-24hss), AUC/minimum inhibitory concentration (MIC), and time above the MIC during the dosing interval (T > MIC) while QTc prolongation was associated to maximal concentration at steady state (Cmaxss) in a thorough QTc Phase 1 study...
November 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29133038/new-metalo-therapeutics-of-nsaids-against-human-breast-cancer-cells
#20
Christina N Banti, Constantina Papatriantafyllopoulou, Anastasios J Tasiopoulos, Sotiris K Hadjikakou
The non steroidal anti-inflammatory drugs (NSAID's)-silver(I) metallodrugs of aspirin (aspH), salicylic acid (salH2), naproxen (napH) acid or p-hydrobenzoic acid (pHbzaH) and the mitochondriotropic triphenylarsine (tpAs) with the formulae [Ag(asp)(tpAs)3] (1), [Ag(salH)(tpAs)3] (2), [Ag(nap)(tpAs)3] (3) and {[Ag(pHbza)(tpAs)3]∙(dmf)} (4) and [Ag(tpAs)3(NO3)] (5) have been synthesized and characterized by m.p., FT-IR, UV-vis and (1)H NMR, spectroscopic techniques and X-ray crystallography. The in vitro cytotoxic activity of 1-5 against human breast adenocarcinoma cancer cells: MCF-7 (positive to estrogen receptors (ERs)) and MDA-MB-231 (negative to estrogen receptors (ERs)) was evaluated...
November 10, 2017: European Journal of Medicinal Chemistry
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