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https://www.readbyqxmd.com/read/28213685/prasugrel-for-japanese-patients-with-acute-coronary-syndrome-in-short-term-clinical-practice-prasfit-practice-i-a-postmarketing-observational-study
#1
Masato Nakamura, Tomoko Iizuka, Kei Sagawa, Kenji Abe, Shuichi Chikada, Miyuki Arai
: Data on prasugrel use in Japanese patients are limited to phase II/III clinical trials. This early postmarketing observational study evaluated the safety and efficacy of short-term prasugrel use in patients with acute coronary syndrome (ACS) in real-world clinical settings in Japan. From May 2014 to January 2015, we enrolled consecutive patients with ACS requiring percutaneous coronary intervention in each institution. Each patient started prasugrel treatment ≥1 month before the end of the study period...
February 17, 2017: Cardiovascular Intervention and Therapeutics
https://www.readbyqxmd.com/read/28213002/a-phase-ii-trial-of-dovitinib-in-previously-treated-advanced-pleural-mesothelioma-the-ontario-clinical-oncology-group
#2
Scott A Laurie, Desiree Hao, Natasha B Leighl, John Goffin, Abderrahim Khomani, Ashish Gupta, Christina L Addison, Anita Bane, Jean Seely, Marc L Filion, Gregory R Pond, Mark N Levine
OBJECTIVES: Following failure of a platinum-antifolate combination regimen, there is no standard therapy for advanced malignant pleural mesothelioma (MPM). The fibroblast growth factor receptor (FGFR) signaling pathways may be a relevant target in MPM. Dovitinib inhibits multiple tyrosine receptor kinases, predominantly the vascular endothelial growth factor receptors (VEGFR), but also FGFRs, and could be active in MPM. METHODS: This open-label multicentre phase II trial [NCT01769547] enrolled fit, consenting adult patients with advanced MPM who had previously received platinum-antifolate combination chemotherapy and up to one additional line of systemic therapy...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28212994/an-open-label-phase-ii-study-of-the-polo-like-kinase-1-plk-1-inhibitor-bi-2536-in-patients-with-relapsed-small-cell-lung-cancer-sclc
#3
Mark M Awad, Quincy S-C Chu, Leena Gandhi, Joe J Stephenson, Ramaswamy Govindan, Daniel S Bradford, Philip D Bonomi, David M Ellison, Keith D Eaton, Holger Fritsch, Gerd Munzert, Bruce E Johnson, Mark A Socinski
OBJECTIVES: This phase II, open-label study was designed to evaluate the response rate to the polo-like kinase 1 (Plk-1) inhibitor BI 2536 in patients with sensitive-relapsed small cell lung cancer (SCLC). Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response, and safety. MATERIALS AND METHODS: Patients were treated with the recommended phase II dose of 200mg of BI 2536 intravenously every 21days. This was a two-stage design with an early stopping rule in place if responses were not seen in at least 2 of the first 18 enrolled patients...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28212992/nivolumab-induced-interstitial-lung-disease-analysis-of-two-phase-ii-studies-patients-with-recurrent-or-advanced-non-small-cell-lung-cancer
#4
Terufumi Kato, Noriyuki Masuda, Yoichi Nakanishi, Masashi Takahashi, Toyoaki Hida, Hiroshi Sakai, Shinji Atagi, Shiro Fujita, Hiroshi Tanaka, Koji Takeda, Miyako Satouchi, Yoshinobu Namba, Tomohide Tamura
OBJECTIVES: Drug-induced interstitial lung disease (ILD) is often associated with high mortality; however it is difficult to predict and manage. we examined the clinical findings and imaging characteristics of nivolumab induced ILD reported in the two phase II studies patients with recurrent or advanced non-small-cell lung cancer. MATERIALS AND METHODS: We examined the clinical findings and imaging characteristics of all cases of ILD reported in two phase II trials of nivolumab, an anti-programmed death-1 antibody, in Japanese patients with recurrent or advanced non-small-cell lung cancer...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28212266/individual-patterns-in-blood-borne-indicators-of-fatigue-trait-or-chance
#5
Ross Julian, Tim Meyer, Hugh H K Fullagar, Sabrina Skorski, Mark Pfeiffer, Michael Kellmann, Alexander Ferrauti, Anne Hecksteden
Julian, R, Meyer, T, Fullagar, HHK, Skorski, S, Pfeiffer, M, Kellmann, M, Ferrauti, A, and Hecksteden, A. Individual patterns in blood-borne indicators of fatigue-trait or chance. J Strength Cond Res 31(3): 608-619, 2017-Blood-borne markers of fatigue such as creatine kinase (CK) and urea (U) are widely used to fine-tune training recommendations. However, predictive accuracy is low. A possible explanation for this dissatisfactory characteristic is the propensity of athletes to react to different patterns of fatigue indicators (e...
March 2017: Journal of Strength and Conditioning Research
https://www.readbyqxmd.com/read/28212060/pembrolizumab-as-second-line-therapy-for-advanced-urothelial-carcinoma
#6
Joaquim Bellmunt, Ronald de Wit, David J Vaughn, Yves Fradet, Jae-Lyun Lee, Lawrence Fong, Nicholas J Vogelzang, Miguel A Climent, Daniel P Petrylak, Toni K Choueiri, Andrea Necchi, Winald Gerritsen, Howard Gurney, David I Quinn, Stéphane Culine, Cora N Sternberg, Yabing Mai, Christian H Poehlein, Rodolfo F Perini, Dean F Bajorin
Background Patients with advanced urothelial carcinoma that progresses after platinum-based chemotherapy have a poor prognosis and limited treatment options. Methods In this open-label, international, phase 3 trial, we randomly assigned 542 patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy to receive pembrolizumab (a highly selective, humanized monoclonal IgG4κ isotype antibody against programmed death 1 [PD-1]) at a dose of 200 mg every 3 weeks or the investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine...
February 17, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28211162/efficacy-of-the-oral-mtorc1-inhibitor-everolimus-in-relapsed-or-refractory-indolent-lymphoma
#7
N Nora Bennani, Betsy R LaPlant, Stephen M Ansell, Thomas M Habermann, David J Inwards, Ivana N Micallef, Patrick B Johnston, Luis F Porrata, Joseph P Colgan, Svetomir N Markovic, Grzegorz S Nowakowski, William R Macon, Craig B Reeder, Joseph R Mikhael, Donald W Northfelt, Irene M Ghobrial, Thomas E Witzig
Relapsed indolent lymphoma often becomes refractory to standard chemoimmunotherapy and requires new therapeutic strategies. Targeting the PI3K/mTOR pathway in several types of lymphoma has shown preclinical and clinical efficacy providing the rationale to test this strategy in the treatment of relapsed/refractory indolent lymphomas. We investigated in a phase II open label clinical trial the efficacy and safety of single agent everolimus, an inhibitor of mTORC1, in patients with relapsed/refractory indolent lymphomas...
February 17, 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28210662/time-course-of-glatiramer-acetate-efficacy-in-patients-with-rrms-in-the-gala-study
#8
Mat D Davis, Natalia Ashtamker, Joshua R Steinerman, Volker Knappertz
OBJECTIVE: To determine the time to efficacy onset of glatiramer acetate (GA) 40 mg/mL 3-times-weekly formulation (GA40). METHODS: This post hoc analysis of data from the 1-year, double-blind, placebo-controlled phase of the Glatiramer Acetate Low-Frequency Administration study (NCT01067521) of GA40 in patients with relapsing-remitting MS (RRMS) sought to determine the timing of efficacy onset using a novel data-censoring approach. RESULTS: Compared with placebo-treated patients, those receiving GA40 exhibited a >30% reduction in the accumulated annualized relapse rate (ARR) within 2 months of initiating treatment and generally sustained this treatment difference during the 1-year study...
March 2017: Neurology® Neuroimmunology & Neuroinflammation
https://www.readbyqxmd.com/read/28209746/a-phase-ii-randomized-trial-go27827-of-first-line-folfox-plus-bevacizumab-with-or-without-the-met-inhibitor-onartuzumab-in-patients-with-metastatic-colorectal-cancer
#9
Johanna C Bendell, Howard Hochster, Lowell L Hart, Irfan Firdaus, Joseph R Mace, Joshua J McFarlane, Mark Kozloff, Daniel Catenacci, Jessie J Hsu, Stephen P Hack, David S Shames, See-Chun Phan, Hartmut Koeppen, Allen L Cohn
BACKGROUND: Dysregulated hepatocyte growth factor/mesenchymal-epithelial transition (MET) signaling is associated with poor prognosis and resistance to vascular endothelial growth factor inhibition in metastatic colorectal cancer (mCRC). We report outcomes from a double-blind, multicenter phase II trial of the MET inhibitor onartuzumab in combination with mFOLFOX-6 and bevacizumab for mCRC (GO27827; NCT01418222). MATERIALS AND METHODS: Patients were randomized 1:1 to receive onartuzumab (10 mg/kg intravenously [IV]) or placebo plus mFOLFOX-6 and bevacizumab (5 mg/kg IV)...
February 16, 2017: Oncologist
https://www.readbyqxmd.com/read/28209728/evaluation-of-cell-therapy-on-exercise-performance-and-limb-perfusion-in-peripheral-artery-disease-the-cctrn-patients-with-intermittent-claudication-injected-with-aldh-bright-cells-pace-trial
#10
Emerson C Perin, Michael P Murphy, Keith L March, Roberto Bolli, John Loughran, Phillip C Yang, Nicholas J Leeper, Ronald L Dalman, Jason Q Alexander, Timothy D Henry, Jay H Traverse, Carl J Pepine, R David Anderson, Scott Berceli, James T Willerson, Raja Muthupillai, Amir A Gahremanpour, Ganesh Raveendran, Omaida C Velazquez, Joshua M Hare, Ivonne H Schulman, Vijaykumar S Kasi, William R Hiatt, Bharath Ambale-Venkatesh, João A Lima, Doris A Taylor, Micheline M Resende, Adrian P Gee, April G Durett, Jeannette Bloom, Sara Richman, Patricia G'Sell, Shari Williams, Fouzia Khan, Elsie G Ross, Michelle R Santoso, JoAnne Goldman, Dana Leach, Eileen Handberg, Benjamin Y C Cheong, Nichole A Piece, Darcy DiFede, Barb Bruhn-Ding, Emily Caldwell, Judy Bettencourt, Dejian Lai, Linda B Piller, Lara M Simpson, Michelle Cohen, Shelly L Sayre, Rachel W Vojvodic, Lem Moyé, Ray F Ebert, Robert D Simari, Alan T Hirsch
Background -Atherosclerotic peripheral artery disease (PAD) affects 8-12% of Americans over 65 and is associated with a major decline in functional status, increased myocardial infarction and stroke rates, and increased risk of ischemic amputation. Current treatment strategies for claudication have limitations. PACE is an NHLBI-sponsored, randomized, double-blind, placebo-controlled phase 2, exploratory clinical trial designed to assess safety and efficacy of autologous bone marrow-derived aldehyde dehydrogenase bright (ALDHbr) cells in PAD patients and to explore associated claudication physiologic mechanisms...
February 16, 2017: Circulation
https://www.readbyqxmd.com/read/28209636/a-randomized-crossover-trial-of-dietary-sodium-restriction-in-stage-3-4-ckd
#11
Rajiv Saran, Robin L Padilla, Brenda W Gillespie, Michael Heung, Scott L Hummel, Vimal Kumar Derebail, Bertram Pitt, Nathan W Levin, Fansan Zhu, Samer R Abbas, Li Liu, Peter Kotanko, Philip Klemmer
BACKGROUND AND OBJECTIVES: Patients with chronic kidney disease (CKD) are often volume expanded and hypertensive. Few controlled studies have assessed the effects of a sodium-restricted diet (SRD) in CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We conducted a randomized crossover trial to evaluate the effect of SRD (target <2 g sodium per day) versus usual diet on hydration status (by bioelectrical impedance spectroscopy) and blood pressure (BP) between May of 2009 and May of 2013...
February 16, 2017: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/28209559/irreversible-electroporation-for-the-ablation-of-renal-cell-carcinoma-a-prospective-human-in-vivo-study-protocol-ideal-phase-2b
#12
Mara Buijs, Krijn P van Lienden, Peter Gk Wagstaff, Matthijs Jv Scheltema, Daniel M de Bruin, Patricia J Zondervan, Otto M van Delden, Ton G van Leeuwen, Jean Jmch de la Rosette, M Pilar Laguna
BACKGROUND: Irreversible electroporation (IRE) is an emerging technique delivering electrical pulses to ablate tissue, with the theoretical advantage to overcome the main shortcomings of conventional thermal ablation. Recent short-term research showed that IRE for the ablation of renal masses is a safe and feasible treatment option. In an ablate and resect design, histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE-targeted renal tumors were completely covered by ablation zone...
February 16, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28209443/continued-benefit-to-rectal-separation-for-prostate-radiation-therapy-final-results-of%C3%A2-a%C3%A2-phase-iii-trial
#13
Daniel A Hamstra, Neil Mariados, John Sylvester, Dhiren Shah, Lawrence Karsh, Richard Hudes, David Beyer, Steven Kurtzman, Jeffrey Bogart, R Alex Hsi, Michael Kos, Rodney Ellis, Mark Logsdon, Shawn Zimberg, Kevin Forsythe, Hong Zhang, Edward Soffen, Patrick Francke, Constantine Mantz, Peter Rossi, Theodore DeWeese, Stephanie Daignault-Newton, Benjamin W Fischer-Valuck, Anupama Chundury, Hiram Gay, Walter Bosch, Jeff Michalski
PURPOSE: SpaceOAR, a Food and Drug Administration-approved hydrogel intended to create a rectal-prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles. The present study reports the final results with a median follow-up period of 3 years. METHODS AND MATERIALS: Cumulative (Common Terminology Criteria for Adverse Events, version 4...
December 23, 2016: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28209419/a-safety-and-pharmacokinetic-dosing-study-of-glucagon-like-peptide-2-in-infants-with-intestinal-failure
#14
David L Sigalet, Mary E Brindle, Dana Boctor, Bryan Dicken, Viona Lam, Lily Sia Lu, Elaine de Heuvel, Bolette Hartmann, Jens J Holst
BACKGROUND & AIMS: Glucagon-like peptide 2 (GLP-2) analogues are approved for adults with intestinal failure (IF), but no studies have included infants. This study examined the pharmacokinetics (PK), safety, and nutritional effects of GLP-2 in infants with IF. METHODS: With parental consent (Health Canada Protocol:150,979), parenteral nutrition (PN)-dependent infants were treated with 5-20-μg/kg/day GLP-2 for 3days (phase 1), and if tolerated continued for 42days (phase 2)...
January 29, 2017: Journal of Pediatric Surgery
https://www.readbyqxmd.com/read/28209298/utidelone-plus-capecitabine-versus-capecitabine-alone-for-heavily-pretreated-metastatic-breast-cancer-refractory-to-anthracyclines-and-taxanes-a-multicentre-open-label-superiority-phase-3-randomised-controlled-trial
#15
Pin Zhang, Tao Sun, Qingyuan Zhang, Zhongyu Yuan, Zefei Jiang, Xiao Jia Wang, Shude Cui, Yuee Teng, Xi-Chun Hu, Junlan Yang, Hongming Pan, Zhongsheng Tong, Huiping Li, Qiang Yao, Yongsheng Wang, Yongmei Yin, Ping Sun, Hong Zheng, Jing Cheng, Jinsong Lu, Baochun Zhang, Cuizhi Geng, Jian Liu, Roujun Peng, Min Yan, Shaohua Zhang, Jian Huang, Li Tang, Rongguo Qiu, Binghe Xu
BACKGROUND: Utidelone, a genetically engineered epothilone analogue, has shown promise as a potential treatment for breast cancer in phase 1 and 2 trials. The aim of this phase 3 trial was to compare the efficacy and safety of utidelone plus capecitabine versus capecitabine alone in patients with metastatic breast cancer. METHODS: We did a multicentre, open-label, superiority, phase 3, randomised controlled trial in 26 hospitals in China. Eligible participants were female patients with metastatic breast cancer refractory to anthracycline and taxane chemotherapy regimens...
February 10, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28209296/best-time-to-assess-complete-clinical-response-after-chemoradiotherapy-in-squamous-cell-carcinoma-of-the-anus-act-ii-a-post-hoc-analysis-of-randomised-controlled-phase-3-trial
#16
Robert Glynne-Jones, David Sebag-Montefiore, Helen M Meadows, David Cunningham, Rubina Begum, Fawzi Adab, Kim Benstead, Robert J Harte, Jill Stewart, Sandy Beare, Allan Hackshaw, Latha Kadalayil
BACKGROUND: Guidelines for anal cancer recommend assessment of response at 6-12 weeks after starting treatment. Using data from the ACT II trial, we determined the optimum timepoint to assess clinical tumour response after chemoradiotherapy. METHODS: The previously reported ACT II trial was a phase 3 randomised trial of patients of any age with newly diagnosed, histologically confirmed, squamous cell carcinoma of the anus without metastatic disease from 59 centres in the UK...
February 10, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28209070/assessment-of-quality-of-life-in-phase-iii-trials-of-radiotherapy-in-localized-or-locally-advanced-head-and-neck-cancer-over-the-past-17-years
#17
Gustavo Nader Marta, Everardo D Saad
BACKGROUND: We investigated the extent to which health-related quality of life (HRQOL) parameters have been used as endpoints in recent phase III trials on radiotherapy for head and neck cancer, as well as the frequency and correlates of significant HRQOL gains. METHODS: Using the medical subject headings "head and neck neoplasms" and "radiotherapy", we searched PubMed for the main paper reporting phase III trials published between 1/1999 and 12/2015 in 16 leading journals...
January 2017: Annals of Palliative Medicine
https://www.readbyqxmd.com/read/28208708/the-interplay-between-inflammation-coagulation-and-endothelial-injury-in-the-early-phase-of-acute-pancreatitis-clinical-implications
#18
REVIEW
Paulina Dumnicka, Dawid Maduzia, Piotr Ceranowicz, Rafał Olszanecki, Ryszard Drożdż, Beata Kuśnierz-Cabala
Acute pancreatitis (AP) is an inflammatory disease with varied severity, ranging from mild local inflammation to severe systemic involvement resulting in substantial mortality. Early pathologic events in AP, both local and systemic, are associated with vascular derangements, including endothelial activation and injury, dysregulation of vasomotor tone, increased vascular permeability, increased leukocyte migration to tissues, and activation of coagulation. The purpose of the review was to summarize current evidence regarding the interplay between inflammation, coagulation and endothelial dysfunction in the early phase of AP...
February 8, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28207834/a-cyclin-dependent-kinase-inhibitor-dinaciclib-in-preclinical-treatment-models-of-thyroid-cancer
#19
Shu-Fu Lin, Jen-Der Lin, Chuen Hsueh, Ting-Chao Chou, Richard J Wong
BACKGROUND: We explored the therapeutic effects of dinaciclib, a cyclin-dependent kinase (CDK) inhibitor, in the treatment of thyroid cancer. MATERIALS AND METHODS: Seven cell lines originating from three pathologic types of thyroid cancer (papillary, follicular and anaplastic) were studied. The cytotoxicity of dinaciclib was measured using a lactate dehydrogenase assay. The expression of proteins associated with cell cycle and apoptosis was assessed using Western blot analysis and immunofluorescence microscopy...
2017: PloS One
https://www.readbyqxmd.com/read/28207628/earlier-endpoints-are-required-for-hemorrhagic-shock-trials-among-severely-injured-patients
#20
Erin E Fox, John B Holcomb, Charles E Wade, Eileen M Bulger, Barbara C Tilley
BACKGROUND: Choosing the appropriate endpoint for a trauma hemorrhage control trial can determine the likelihood of its success. Recent Phase 3 trials and observational studies have used 24-h and/or 30-day all-cause mortality as the primary endpoint and some have not used exception from informed consent (EFIC), resulting in multiple failed trials. Five recent high-quality prospective studies among 4,064 hemorrhaging trauma patients provide new evidence to support earlier primary endpoints...
February 15, 2017: Shock
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