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randomized, double-bind, phase iii

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https://www.readbyqxmd.com/read/27821382/a-prospective-multicenter-randomized-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-eculizumab-in-patients-with-guillain-barr%C3%A3-syndrome-gbs-protocol-of-japanese-eculizumab-trial-for-gbs-jet-gbs
#1
Nobuko Yamaguchi, Sonoko Misawa, Yasunori Sato, Kengo Nagashima, Kanako Katayama, Yukari Sekiguchi, Yuta Iwai, Hiroshi Amino, Tomoki Suichi, Takanori Yokota, Yoichiro Nishida, Nobuo Kohara, Koichi Hirata, Kazutoshi Nishiyama, Ichiro Yabe, Ken-Ichi Kaida, Norihiro Suzuki, Hiroyuki Nodera, Shoji Tsuji, Haruki Koike, Jun-Ichi Kira, Hideki Hanaoka, Susumu Kusunoki, Satoshi Kuwabara
BACKGROUND: Guillain-Barré syndrome (GBS) is an immune-mediated neuropathy that causes acute flaccid paralysis. Immunoglobulin and plasma exchange are established treatments for GBS; however, a substantial number of patients, particularly those with severe disease, have poor recovery and residual deficits. Recent studies suggest that complement activation plays a pivotal role in GBS-associated axonal degeneration, and eculizumab is a humanized monoclonal antibody that specifically binds to complement component 5 and potently inhibits complement activation...
November 7, 2016: JMIR Research Protocols
https://www.readbyqxmd.com/read/27595681/a-randomized-parallel-group-double-blind-study-of-ticagrelor-compared-with-aspirin-for-prevention-of-vascular-events-in-patients-undergoing-coronary-artery-bypass-graft-operation-rationale-and-design-of-the-ticagrelor-in-cabg-ticab-trial-an-investigator-initiated
#2
Antoinette de Waha, Sigrid Sandner, Moritz von Scheidt, Andreas Boening, Katharina Koch-Buettner, Dieter Hammel, Rainer Hambrecht, Bernhard C Danner, Friedrich A Schöndube, Gerold Goerlach, Theodor Fischlein, Michael Schmoeckel, Martin Oberhoffer, Rainer Schulz, Thomas Walther, Tibor Ziegelhöffer, Christoph Knosalla, Felix Schönrath, Friedhelm Beyersdorf, Matthias Siepe, Tim Attmann, Martin Misfeld, Friedrich-Wilhelm Mohr, Hans-Hinrich Sievers, Alexander Joost, Leon M Putman, Günther Laufer, Christian Hamm, Uwe Zeymer, Adnan Kastrati, Peter W Radke, Rüdiger Lange, Jochen Cremer, Heribert Schunkert
BACKGROUND: For patients with coronary artery disease undergoing coronary bypass surgery, acetylsalicylic acid (ASA) currently represents the gold standard of antiplatelet treatment. However, adverse cardiovascular event rates in the first year after coronary artery bypass grafting (CABG) still exceed 10%. Graft failure, which is predominantly mediated by platelet aggregation, has been identified as a major contributing factor in this context. Therefore, intensified platelet inhibition is likely to be beneficial...
September 2016: American Heart Journal
https://www.readbyqxmd.com/read/27393581/sodium-zirconium-cyclosilicate-zs-9-a-novel-agent-for-the-treatment-of-hyperkalemia
#3
REVIEW
Kristin E Linder, Michelle A Krawczynski, Dayne Laskey
Hyperkalemia is a potentially life-threatening electrolyte abnormality that may be caused by select medications, underlying organ dysfunction, or alterations in potassium homeostasis. Treatment for this condition has remained largely unchanged since the release of sodium polystyrene sulfonate (SPS) in 1958. Despite its widespread use, the safety and efficacy of SPS remains controversial. Two novel potassium-binding resins have emerged in recent years. Patiromer was the first of these to receive U.S. Food and Drug Administration approval for the treatment of hyperkalemia in October 2015...
August 2016: Pharmacotherapy
https://www.readbyqxmd.com/read/27001568/a-randomized-double-blind-placebo-controlled-phase-iii-study-to-assess-efficacy-and-safety-of-weekly-farletuzumab-in-combination-with-carboplatin-and-taxane-in-patients-with-ovarian-cancer-in-first-platinum-sensitive-relapse
#4
Ignace Vergote, Deborah Armstrong, Giovanni Scambia, Michael Teneriello, Jalid Sehouli, Charles Schweizer, Susan C Weil, Aristotelis Bamias, Keiichi Fujiwara, Kazunori Ochiai, Christopher Poole, Vera Gorbunova, Wenquan Wang, Daniel O'Shannessy, Thomas J Herzog
PURPOSE: Farletuzumab is a humanized monoclonal antibody that binds to folate receptor-α, which is highly expressed in ovarian carcinoma and largely absent from normal tissue. Farletuzumab was investigated in a double-blind, randomized phase III study in platinum-sensitive ovarian cancer. PATIENTS AND METHODS: Eligible patients had first recurrent ovarian cancer 6-24 months following completion of platinum-taxane chemotherapy. All patients received carboplatin plus paclitaxel or docetaxel (for six cycles combined with randomly assigned test products in a 1:1:1 ratio: farletuzumab 1...
July 1, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/26946077/comparison-of-pcsk9-inhibitor-evolocumab-vs-ezetimibe-in-statin-intolerant-patients-design-of-the-goal-achievement-after-utilizing-an-anti-pcsk9-antibody-in-statin-intolerant-subjects-3-gauss-3-trial
#5
Steven E Nissen, Ricardo E Dent-Acosta, Robert S Rosenson, Erik Stroes, Naveed Sattar, David Preiss, G B John Mancini, Christie M Ballantyne, Alberico Catapano, Ioanna Gouni-Berthold, Evan A Stein, Allen Xue, Scott M Wasserman, Rob Scott, Paul D Thompson
Statins are the accepted standard for lowering low-density lipoprotein cholesterol (LDL-C). However, 5% to 10% of statin-treated patients report intolerance, mostly due to muscle-related adverse effects. Challenges exist to objective identification of statin-intolerant patients. Evolocumab is a monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9), resulting in marked LDL-C reduction. We report the design of Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin-Intolerant Subjects 3 (GAUSS-3), a phase 3, multicenter, randomized, double-blind, ezetimibe-controlled study to compare effectiveness of 24 weeks of evolocumab 420 mg monthly vs ezetimibe 10 mg daily in hypercholesterolemic patients unable to tolerate an effective statin dose...
March 2016: Clinical Cardiology
https://www.readbyqxmd.com/read/26239948/ferric-citrate-an-iron-based-phosphate-binder-reduces-health-care-costs-in-patients-on-dialysis-based-on-randomized-clinical-trial-data
#6
RANDOMIZED CONTROLLED TRIAL
Roger A Rodby, Kausik Umanath, Robert Niecestro, T Christopher Bond, Mohammed Sika, Julia Lewis, Jamie P Dwyer
BACKGROUND: Patients with end-stage renal disease (ESRD) require phosphate binders for hyperphosphatemia and erythropoiesis-stimulating agents (ESAs) and intravenous (i.v.) iron for anemia. Ferric citrate (FC) is a novel, iron-based phosphate binder that increases iron stores and decreases i.v. iron and ESA usage while maintaining hemoglobin levels, and may decrease the cost of ESRD care. The study objectives were to (1) quantify differences in ESA and i.v. iron usage among ESRD patients receiving FC compared with active control (AC) (sevelamer carbonate and/or calcium acetate) on the basis of data from a 52-week phase III clinical trial and (2) standardize trial data to the general United States (US) ESRD population and calculate the potential impact of FC on ESRD cost/patient/year in the USA...
September 2015: Drugs in R&D
https://www.readbyqxmd.com/read/26137956/effect-of-the-myeloperoxidase-inhibitor-azd3241-on-microglia-a-pet-study-in-parkinson-s-disease
#7
RANDOMIZED CONTROLLED TRIAL
Aurelija Jucaite, Per Svenningsson, Juha O Rinne, Zsolt Cselényi, Katarina Varnäs, Peter Johnström, Nahid Amini, Anna Kirjavainen, Semi Helin, Margaret Minkwitz, Alan R Kugler, Joel A Posener, Samantha Budd, Christer Halldin, Andrea Varrone, Lars Farde
Impaired mitochondrial function, oxidative stress and formation of excessive levels of reactive oxygen species play a key role in neurodegeneration in Parkinson's disease. Myeloperoxidase is a reactive oxygen generating enzyme and is expressed by microglia. The novel compound AZD3241 is a selective and irreversible inhibitor of myeloperoxidase. The hypothesized mechanism of action of AZD3241 involves reduction of oxidative stress leading to reduction of sustained neuroinflammation. The purpose of this phase 2a randomized placebo controlled multicentre positron emission tomography study was to examine the effect of 8 weeks treatment with AZD3241 on microglia in patients with Parkinson's disease...
September 2015: Brain: a Journal of Neurology
https://www.readbyqxmd.com/read/26075487/efficacy-and-safety-of-cariprazine-in-acute-exacerbation-of-schizophrenia-results-from-an-international-phase-iii-clinical-trial
#8
RANDOMIZED CONTROLLED TRIAL
John M Kane, Stephen Zukin, Yao Wang, Kaifeng Lu, Adam Ruth, Krisztián Nagy, István Laszlovszky, Suresh Durgam
This phase III study evaluated the efficacy and safety of cariprazine, a dopamine D3 and D2 receptor partial agonist with preferential binding to D3 receptors, in patients with acute exacerbation of schizophrenia. Patients were randomized to 6-week double-blind treatment with placebo, cariprazine 3 to 6 mg/d, or cariprazine 6 to 9 mg/d. Primary and secondary efficacy: change from baseline to week 6 in Positive and Negative Syndrome Scale total and Clinical Global Impressions-Severity scores, respectively, analyzed using a mixed-effects model for repeated measures adjusting for multiple comparisons...
August 2015: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/26042589/tildrakizumab-mk-3222-an-anti-interleukin-23p19-monoclonal-antibody-improves-psoriasis-in-a-phase-iib-randomized-placebo-controlled-trial
#9
RANDOMIZED CONTROLLED TRIAL
K Papp, D Thaçi, K Reich, E Riedl, R G Langley, J G Krueger, A B Gottlieb, H Nakagawa, E P Bowman, A Mehta, Q Li, Y Zhou, R Shames
BACKGROUND: Tildrakizumab is a high-affinity, humanized, IgG1/κ, anti-interleukin (IL)-23p19 monoclonal antibody that does not bind human IL-12 or p40 is being developed for the treatment of chronic plaque psoriasis. OBJECTIVES: To evaluate the safety and efficacy of subcutaneous tildrakizumab in patients with moderate-to-severe chronic plaque psoriasis. METHODS: A three-part, randomized, double-blind, phase IIb trial was conducted in 355 adults with chronic plaque psoriasis...
October 2015: British Journal of Dermatology
https://www.readbyqxmd.com/read/25986193/absence-of-liver-toxicity-in-perampanel-treated-subjects-pooled-results-from-partial-seizure-phase-iii-perampanel-clinical-studies
#10
Antonio Laurenza, Haichen Yang, Betsy Williams, Sharon Zhou, Jim Ferry
OBJECTIVE: The liver plays a major role in the metabolism and elimination of many antiepileptic drugs (AEDs), including perampanel. Some of the metabolites identified for perampanel are likely formed via reactive intermediates, which have the potential to covalently bind to protein and cause idiosyncratic toxicities, including hepatotoxicity. The approved AED perampanel is a selective, noncompetitive AMPA receptor antagonist. The safety and tolerability of perampanel have been well documented in 3 double-blind, randomized, placebo-controlled, phase III studies...
July 2015: Epilepsy Research
https://www.readbyqxmd.com/read/25420897/racotumomab-alum-vaccine-for-the-treatment-of-non-small-cell-lung-cancer
#11
REVIEW
Ana María Hernández, Ana María Vázquez
Racotumomab-alum vaccine is an anti-idiotypic vaccine able to mimic the tumor-associated antigen NeuGcGM3. Different Phase I clinical trials and compassionate use studies demonstrated its low toxicity and capacity to induce a strong anti-NeuGcGM3 response, able to bind and directly kill tumor cells expressing the antigen. A Phase II/III randomized double-blind clinical trial in advanced non-small cell lung cancer patients showed a significant improvement in overall survival and progression-free survival for racotumomab-alum versus placebo...
January 2015: Expert Review of Vaccines
https://www.readbyqxmd.com/read/25233856/a-multinational-phase-iib-iii-trial-of-beraprost-sodium-an-orally-active-prostacyclin-analogue-in-patients-with-primary-glomerular-disease-or-nephrosclerosis-cassiopeir-trial-rationale-and-study-design
#12
RANDOMIZED CONTROLLED TRIAL
Hidetomo Nakamoto, Toshiro Fujita, Hideki Origasa, Masanao Isono, Hajimu Kurumatani, Kiyonobu Okada, Hiroyuki Kanoh, Takashi Kiriyama, Shunsuke Yamada
BACKGROUND: Chronic kidney disease (CKD) is public health concern even in Asian countries. TRK-100STP, a sustained release tablet of an orally-active prostacyclin analogue, beraprost sodium, is suggested to suppress worsening of some parameters of renal filtration function, containing in slope of 1/serum creatinine (1/SCr) vs. time in a phase II clinical trial. METHODS/DESIGN: We describe the design of the phase IIb/III trial of TRK-100STP, CASSIOPEIR (CRF Asian Study with Oral PGI2 derivative for Evaluating Improvement of Renal function) conducted in approximately 160 centers in China, Hong Kong, Japan, Malaysia, Republic of Korea, Taiwan, and Thailand...
September 19, 2014: BMC Nephrology
https://www.readbyqxmd.com/read/25185099/primary-results-of-rose-trio-12-a-randomized-placebo-controlled-phase-iii-trial-evaluating-the-addition-of-ramucirumab-to-first-line-docetaxel-chemotherapy-in-metastatic-breast-cancer
#13
RANDOMIZED CONTROLLED TRIAL
John R Mackey, Manuel Ramos-Vazquez, Oleg Lipatov, Nicole McCarthy, Dmitriy Krasnozhon, Vladimir Semiglazov, Alexey Manikhas, Karen A Gelmon, Gottfried E Konecny, Marc Webster, Roberto Hegg, Sunil Verma, Vera Gorbunova, Dany Abi Gerges, Francois Thireau, Helena Fung, Lorinda Simms, Marc Buyse, Ayman Ibrahim, Miguel Martin
PURPOSE: Currently, antiangiogenic strategies in metastatic breast cancer have demonstrated modest improvements in progression-free survival (PFS) but not improved quality or duration of survival, warranting evaluation of new agents in a placebo-controlled setting. Ramucirumab is a human immunoglobulin G1 antibody that binds vascular endothelial growth factor receptor-2 and blocks ligand-stimulated activation. The ROSE/TRIO-012 trial evaluated ramucirumab with docetaxel in unresectable, locally recurrent, or metastatic breast cancer...
January 10, 2015: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/25131864/-enzalutamide-a-novel-androgen-receptor-inhibitor-that-provides-treatment-options-for-patients-with-castration-resistant-prostate-cancer
#14
Hideki Maeda, Atsushi Saito
The recent emergence of new hormonal or chemotherapeutic drugs has resulted in a paradigm shift in the treatment of castration-resistant prostate cancer(CRPC). Enzalutamide is a rationally designed, orally administered androgen receptor(AR)inhibitor. It inhibits multiple points in the androgen receptor signalling pathway, which is considered an important driver of CRPC, including the inhibition of androgen binding to the AR, nuclear translocation of the AR complex, and binding of the AR complex to deoxyribonucleic acid(DNA)...
July 2014: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/25099958/tocilizumab-a-humanized-anti-il-6r-antibody-as-an-emerging-therapeutic-option-for-rheumatoid-arthritis-molecular-and-cellular-mechanistic-insights
#15
REVIEW
Misato Hashizume, Seng-Lai Tan, Junichi Takano, Kazunori Ohsawa, Ikuo Hasada, Akira Hanasaki, Ichiro Ito, Masahiko Mihara, Keiichiro Nishida
Pro-inflammatory cytokines play a major role in the initiation and maintenance of joint inflammation and destruction in rheumatoid arthritis (RA). The therapeutic success of biologics targeting tumour necrosis factor-alpha (TNF-α), interleukin-1 (IL-1) and interleukin (IL)-6 receptor (IL-6R) has broadened the treatment options for RA. These agents have potential overlapping and discriminating biologic effects, as well as different pharmacological features. Tocilizumab (TCZ) is a humanized monoclonal antibody that binds and neutralizes IL-6R, resulting in the inhibition of various IL-6-mediated biological activities, including inflammation-related, immunomodulatory and tissue/matrix remodelling effects...
May 2015: International Reviews of Immunology
https://www.readbyqxmd.com/read/24472850/associations-between-vitamin-d-binding-protein-isotypes-circulating-25-oh-d-levels-and-vitamin-d-metabolite-uptake-in-colon-cancer-cells
#16
Elizabeth A Hibler, Elizabeth T Jacobs, Angelika Dampf Stone, Christine L Sardo, Michael A Galligan, Peter W Jurutka
Vitamin D metabolites have been extensively studied as cancer chemopreventive agents. Gc-globulin (GC) isotypes, based on rs7041 and rs4588 diplotypes, have varying affinities for 1α,25-dihydroxyvitamin D (1,25(OH)2D) and 25-hydroxyvitamin D (25(OH)D), which may affect circulating metabolite concentration as well as delivery at the cellular level. We evaluated associations between GC isotype and circulating vitamin D metabolite concentrations in 403 ursodeoxycholic acid (UDCA) clinical trial participants. Metabolite uptake was evaluated in human colon cancer (HCT-116) cells treated with ethanol vehicle, 1,25(OH)2D, or 25(OH)D, and with plasma from individuals with known GC isotype...
April 2014: Cancer Prevention Research
https://www.readbyqxmd.com/read/24367183/clinical-utility-of-the-combination-of-lapatinib-and-letrozole-in-the-management-of-hormone-receptor-positive-and-her2-positive-advanced-breast-cancer
#17
REVIEW
Priscilla Merriam, William M Sikov
Breast cancers that overexpress human epidermal growth factor receptor-2 (HER2-positive [HER2+]) tend to be biologically aggressive and associated with a poor prognosis, even those that coexpress receptors for estrogen and/or progesterone (hormone receptor-positive [HR+]). Optimal therapy for patients with "double-positive" (HR+/HER2+) breast cancers is still being defined. In this subset of patients, the efficacy of targeted endocrine therapies appears to be diminished by cross-activation or "crosstalk" between estrogen receptor-mediated gene transcription and pathways activated by other growth factor receptors, including HER2...
October 26, 2011: Breast Cancer: Targets and Therapy
https://www.readbyqxmd.com/read/23982598/pertuzumab-a-review-of-its-use-for-first-line-combination-treatment-of-her2-positive-metastatic-breast-cancer
#18
REVIEW
Paul L McCormack
Pertuzumab (Perjeta®) is a humanized anti-HER2 monoclonal antibody that binds to the extracellular dimerization subdomain of the HER2 receptor and reduces HER2 intracellular signalling by preventing HER2 from forming heterodimers with other HER receptors. Inhibition of HER2 signalling results in a reduction of tumour cell proliferation, invasiveness and survival. Pertuzumab and trastuzumab bind to different sites on the HER2 receptor and have complementary antitumour activities; they act synergistically in inhibiting the growth of HER2-overexpressing breast cancer cell lines in vitro...
September 2013: Drugs
https://www.readbyqxmd.com/read/23762146/inhibition-of-lxr%C3%AE-srebp-1c-mediated-hepatic-steatosis-by-jiang-zhi-granule
#19
Miao Wang, Shanshan Sun, Tao Wu, Li Zhang, Haiyan Song, Weiwei Hao, Peiyong Zheng, Lianjun Xing, Guang Ji
Nonalcoholic fatty liver (NAFL) is increasingly recognized as one of the most common causes of chronic liver disease worldwide. Traditional Chinese medicine (TCM), as the alternative and complementary medicine, may provide some profound health benefit. "Jiang-Zhi" Granule (JZG) was composed based on TCM pathogenesis of NAFL: the retention of inner dampness, heat and blood stasis. This study investigated effects of JZG on liver X receptor-α (LXRα)/sterol regulatory element binding protein-1c (SREBP-1c) pathway in high-fat-diet-(HFD-)induced hepatic steatosis, as well as in free-fatty-acid-(FFA-)and T0901317-treated HepG2 cells...
2013: Evidence-based Complementary and Alternative Medicine: ECAM
https://www.readbyqxmd.com/read/23456653/b-cell-targeted-therapies-in-systemic-lupus-erythematosus-successes-and-challenges
#20
Philip R Harvey, Caroline Gordon
Systemic lupus erythematosus is a multisystem autoimmune disease characterized by the formation of autoantibodies that target a variety of self antigens. B cells are fundamental to the development of these antibodies and are a target for intervention in the disease. This review discusses four therapies that target B cells by inducing B-cell depletion, reduction in B-cell proliferation and differentiation, or modulation of B-cell function. Rituximab is an anti-CD20 chimeric monoclonal antibody that depletes B cells but not plasma cells...
April 2013: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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