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https://www.readbyqxmd.com/read/29036255/tavaborole-in-difficult-to-treat-onychomycosis-cases-a-post-hoc-assessment-of-phase-iii-subjects
#1
Raza Aly, Aditya K Gupta, Tate Winter, Lee T Zane, Tracey Vlahovic
Toenail onychomycosis is a chronic fungal infection that often requires prolonged treatment in order to effectively manage pathogenic organisms and obtain a clear nail. Traditionally, certain clinical features of onychomycosis, including the presence of substantial lateral disease, focal fungal masses, yellow/brown streaks, and extensive nail involvement (ie, >50%), indicate a poor treatment prognosis and have proven difficult-to-treat with oral or traditional topical therapies. Owing to the novel features of topical tavaborole, we sought to understand the potential utility of tavaborole in difficult-to-treat onychomycosis...
October 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29035947/cross-reactivity-of-hiv-vaccine-responses-and-the-microbiome
#2
Wilton B Williams, Qifeng Han, Barton F Haynes
PURPOSE OF REVIEW: A successful HIV-type 1 (HIV-1) vaccine will require immunogens that induce protective immune responses. However, recent studies suggest that the response to HIV-1 and perhaps other viruses may be altered by immune system exposure to intestinal microbiota-antigens. This review will discuss select aspects of these studies. RECENT FINDINGS: Naïve CD4 T and B cell repertoires can be imprinted by intestinal microbiota-antigens to respond to virus epitopes prior to virus infection...
October 14, 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/29034366/a-phase-2-study-incorporating-sorafenib-into-the-chemotherapy-for-older-adults-with-flt3-mutated-acute-myeloid-leukemia-calgb-11001
#3
Geoffrey L Uy, Sumithra J Mandrekar, Kristina Laumann, Guido Marcucci, Weiqiang Zhao, Mark J Levis, Heidi D Klepin, Maria R Baer, Bayard L Powell, Peter Westervelt, Daniel J DeAngelo, Wendy Stock, Ben Sanford, William G Blum, Clara D Bloomfield, Richard M Stone, Richard A Larson
The Cancer and Leukemia Group B (CALGB), now part of the Alliance for Clinical Trials in Oncology, conducted a multicenter, single-arm, phase 2 study in patients ≥60 years with FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML). In this study, sorafenib was added to daunorubicin and cytarabine-based induction and consolidation chemotherapy and was also continued for 12 months of maintenance therapy. The primary end point of the study was overall survival (OS) at 1 year in the FLT3 internal tandem duplication (FLT3-ITD) cohort...
January 24, 2017: Blood Advances
https://www.readbyqxmd.com/read/29034009/a-multicenter-randomized-study-of-decitabine-as-epigenetic-priming-with-induction-chemotherapy-in-children-with-aml
#4
Lia Gore, Timothy J Triche, Jason E Farrar, Daniel Wai, Christophe Legendre, Gerald C Gooden, Winnie S Liang, John Carpten, David Lee, Frank Alvaro, Margaret E Macy, Carola Arndt, Philip Barnette, Todd Cooper, Laura Martin, Aru Narendran, Jessica Pollard, Soheil Meshinchi, Jessica Boklan, Robert J Arceci, Bodour Salhia
BACKGROUND: Decitabine is a deoxycytidine nucleoside derivative inhibitor of DNA-methyltransferases, which has been studied extensively and is approved for myelodysplastic syndrome in adults but with less focus in children. Accordingly, we conducted a phase 1 multicenter, randomized, open-label study to evaluate decitabine pre-treatment before standard induction therapy in children with newly diagnosed AML to assess safety and tolerability and explore a number of biologic endpoints. RESULTS: Twenty-four patients were fully assessable for all study objectives per protocol (10 in Arm A = epigenetic priming induction, 14 in Arm B = standard induction)...
2017: Clinical Epigenetics
https://www.readbyqxmd.com/read/29033933/monocyte-chemotactic-protein-1-in-plasma-from-soluble-leishmania-antigen-stimulated-whole-blood-as-a-potential-biomarker-of-the-cellular-immune-response-to-leishmania-infantum
#5
Ana V Ibarra-Meneses, Carmen Sanchez, Jorge Alvar, Javier Moreno, Eugenia Carrillo
New biomarkers are needed to identify asymptomatic Leishmania infection as well as immunity following vaccination or treatment. With the aim of finding a robust biomarker to assess an effective cellular immune response, monocyte chemotactic protein 1 (MCP-1) was examined in plasma from soluble Leishmania antigen (SLA)-stimulated whole blood collected from subjects living in a Leishmania infantum-endemic area. MCP-1, expressed 110 times more strongly than IL-2, identified 87.5% of asymptomatic subjects and verified some asymptomatic subjects close to the cutoff...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/29033620/comparative-safety-of-intravenous-ferumoxytol-versus-ferric-carboxymaltose-for-the-treatment-of-iron-deficiency-anemia-rationale-and-study-design-of-a-randomized-double-blind-study-with-a-focus-on-acute-hypersensitivity-reactions
#6
N Franklin Adkinson, William E Strauss, Kristine Bernard, Robert F Kaper, Iain C Macdougall, Julie S Krop
BACKGROUND: Intravenous (IV) iron is often used to treat iron deficiency anemia in patients who are unable to tolerate or are inadequately managed with oral iron. However, IV iron treatment has been associated with acute hypersensitivity reactions. The comparative risk of adverse events (AEs) with IV iron preparations has been assessed by a few randomized controlled trials, which are most often limited by small patient numbers, which lack statistical power to identify differences in low-frequency AE such as hypersensitivity reactions...
2017: Journal of Blood Medicine
https://www.readbyqxmd.com/read/29033605/onabotulinum-toxin-a-in-the-treatment-of-chronic-migraine-patient-selection-and-special-considerations
#7
REVIEW
Piero Barbanti, Patrizia Ferroni
Discovered by serendipity, onabotulinum toxin A (BoNT-A) is the only US Food and Drug Administration-approved treatment for the prevention of chronic migraine (CM), one of the most disabling and burdensome human conditions. Its efficacy, safety and tolerability, proved by the largest and longest migraine therapeutic trial (the Phase III Research Evaluating Migraine Prophylaxis Therapy program [PREEMPT]), have been replicated by various real-life studies also in the presence of medication overuse. The benefit of BoNT-A prophylaxis is likely due to its ability to counteract peripheral and central nociceptive sensitization through reversible chemical denervation of pericranial sensitive afferents...
2017: Journal of Pain Research
https://www.readbyqxmd.com/read/29033594/cost-effectiveness-analysis-of-intravenous-ferumoxytol-for-the-treatment-of-iron-deficiency-anemia-in-adult-patients-with-non-dialysis-dependent-chronic-kidney-disease-in-the-usa
#8
Naomi V Dahl, Robert F Kaper, William E Strauss, Frank A Corvino, Marko Zivkovic
OBJECTIVE: Ferumoxytol has demonstrated superior efficacy compared with oral iron in treating iron deficiency anemia in chronic kidney disease (CKD) patients. However, an economic evaluation of ferumoxytol has not been conducted. The aim of this study was to analyze the cost-effectiveness of treating iron deficiency anemia in adult non-dialysis-dependent CKD patients with ferumoxytol as compared with oral iron, alone or in combination with erythropoietin-stimulating agents (ESAs). METHODS: A decision analytic model compared health outcomes and costs associated with 5-week outpatient treatment of adult non-dialysis-dependent CKD patients with ferumoxytol or oral iron, each as monotherapy or in combination with ESAs in the USA...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/29033099/custirsen-ogx-011-combined-with-cabazitaxel-and-prednisone-versus-cabazitaxel-and-prednisone-alone-in-patients-with-metastatic-castration-resistant-prostate-cancer-previously-treated-with-docetaxel-affinity-a-randomised-open-label-international-phase-3-trial
#9
Tomasz M Beer, Sebastien J Hotte, Fred Saad, Boris Alekseev, Vsevolod Matveev, Aude Fléchon, Gwenaelle Gravis, Florence Joly, Kim N Chi, Zafar Malik, Brent Blumenstein, Patricia S Stewart, Cindy A Jacobs, Karim Fizazi
BACKGROUND: Docetaxel and cabazitaxel improve overall survival compared with mitoxantrone in patients with metastatic castration-resistant prostate cancer. Custirsen (OGX011) is a second generation highly specific antisense oligonucleotide that inhibits the production of clusterin, an antiapoptotic protein that is upregulated in response to chemotherapy and that confers treatment resistance. We aimed to assess whether custirsen in combination with cabazitaxel and prednisone increases overall survival in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel...
October 9, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29032666/24-hour-blood-pressure-response-to-lower-dose-30-mg-fimasartan-in-korean-patients-with-mild-to-moderate-essential-hypertension
#10
Hae-Young Lee, Cheol-Ho Kim, Jae-Kwan Song, Shung Chull Chae, Myung Ho Jeong, Dong-Soo Kim, Byung-Hee Oh
Background/Aims: Fimasartan is an angiotensin type 1 receptor blocker (ARB) which has comparable efficacy and tolerability with other ARBs. The aim of this study was to evaluate 24-hour blood pressure (BP) lowering efficacy and the tolerability of the low dose fimasartan compared with valsartan in patients with mild to moderate hypertension. Methods: This study was a phase II, prospective, multicenter, randomized, double-blind, parallel-grouped trial. A total of 75 hypertensive patients, whose mean ambulatory BP monitoring values were ≥ 135/85 mmHg, were randomized to either fimasartan 30 mg or valsartan 80 mg daily...
October 17, 2017: Korean Journal of Internal Medicine
https://www.readbyqxmd.com/read/29032078/efficacy-and-safety-of-once-monthly-pasireotide-in-cushing-s-disease-a-12-month-clinical-trial
#11
André Lacroix, Feng Gu, Wilson Gallardo, Rosario Pivonello, Yerong Yu, Przemysław Witek, Marco Boscaro, Roberto Salvatori, Masanobu Yamada, Libuse Tauchmanova, Michael Roughton, Shoba Ravichandran, Stephan Petersenn, Beverly M K Biller, John Newell-Price
BACKGROUND: Cushing's disease is a rare debilitating endocrine disorder for which few prospective interventional studies have been done. We report results of the first phase 3 trial assessing long-acting intramuscular pasireotide in patients with Cushing's disease. METHODS: In this phase 3 clinical trial we recruited patients aged 18 years or older with persistent, recurrent, or de-novo (non-surgical candidates) Cushing's disease who had a mean urinary free cortisol (mUFC) concentration (from three 24 h samples) of 1·5-5·0 times the upper limit of normal (ULN), a normal or greater than normal morning plasma adrenocorticotropic hormone concentration, and a pituitary source of Cushing's syndrome, from 57 sites across 19 countries...
October 11, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29032022/outcomes-of-newly-diagnosed-chronic-phase-chronic-myeloid-leukemia-following-an-elective-switch-from-second-generation-tyrosine-kinase-inhibitor-to-imatinib
#12
Vamsi K Kota, Jee Hyun Kong, Martha Arellano, Fuad El Rassi, Manila Gaddh, Leonard T Heffner, Elliott F Winton, Anand P Jillella, Morgan L McLemore, H Jean Khoury
The second-generation tyrosine kinase inhibitors (TKIs) (2G-TKIs) dasatinib (DAS) and nilotinib (NIL) yield faster responses in newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML) as compared with imatinib (IM); however, long-term safety of these agents is a growing concern. We identified 20 patients with CP-CML diagnosed between August 2013 and October 2016 who initiated 2G-TKIs and were then switched after optimal response at 3 months to IM. Second-generation TKIs initiated were DAS (n = 15), NIL (n = 3), or both sequentially due to intolerance (n = 1)...
September 19, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/29031778/extended-adjuvant-aromatase-inhibition-after-sequential-endocrine-therapy-data-a-randomised-phase-3-trial
#13
Vivianne C G Tjan-Heijnen, Irene E G van Hellemond, Petronella G M Peer, Astrid C P Swinkels, Carolien H Smorenburg, Maurice J C van der Sangen, Judith R Kroep, Hiltje De Graaf, Aafke H Honkoop, Frans L G Erdkamp, Franchette W P J van den Berkmortel, Maaike de Boer, Wilfred K de Roos, Sabine C Linn, Alexander L T Imholz, Caroline M Seynaeve
BACKGROUND: The effect of extended adjuvant aromatase inhibition in hormone receptor-positive breast cancer after sequential endocrine therapy of tamoxifen followed by an aromatase inhibitor for a 5-year treatment period still needs clarification. To address this issue, we began the DATA study to assess different durations of anastrozole therapy after tamoxifen. METHODS: DATA was a prospective, randomised, open-label, multicentre, phase 3 study done in 79 hospitals in the Netherlands...
October 11, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29031770/effects-of-three-major-amino-acids-found-in-japanese-broth-on-glucose-metabolism-and-gastric-emptying
#14
Fumika Mano, Kaori Ikeda, Erina Joo, Shunsuke Yamane, Norio Harada, Nobuya Inagaki
OBJECTIVES: To our knowledge, the effect of the broth of dried kelp and dried bonito, dashi, on glucose metabolism and digestion has rarely been studied. Based on the component analysis of three actual broths served in traditional restaurants, a chemically synthesized broth with three free amino acids (histidine, glutamate, aspartate) and salt was prepared to investigate their effect on glucose metabolism, glucose-dependent insulinotropic polypeptide (GIP), and glucagon-like peptide 1 (GLP-1) secretion, and digestion...
August 10, 2017: Nutrition
https://www.readbyqxmd.com/read/29031769/intra-trigonal-onabotulinum-toxin-a-improves-bladder-symptoms-and-quality-of-life-in-bladder-pain-syndrome-interstitial-cystitis-patients-a-pilot-single-centre-randomized-double-blind-placebo-controlled-trial
#15
R Pinto, D Costa, A Morgado, P Pereira, A Charrua, J Silva, F Cruz
PURPOSE: To compare efficacy and safety of trigonal injections of onabotulinumtoxinA and saline in Bladder Pain Syndrome/Interstitial Cystitis patients. MATERIALS AND METHODS: This phase II study enrolled women with Bladder Pain Syndrome/Interstitial Cystitis >6months and pain ≥4 in 0-10 visual analogue scale, refractory to common treatment. OnabotulinumtoxinA 100U (n=10) or saline (placebo, n=9), were administered as 10 trigonal injections of 1ml. Primary end-point was change from baseline in pain intensity reported at week 12...
October 12, 2017: Journal of Urology
https://www.readbyqxmd.com/read/29031731/evaluation-of-a-melanocortin-4-receptor-mc4r-agonist-setmelanotide-in-mc4r-deficiency
#16
Tinh-Hai Collet, Béatrice Dubern, Jacek Mokrosinski, Hillori Connors, Julia M Keogh, Edson Mendes de Oliveira, Elana Henning, Christine Poitou-Bernert, Jean-Michel Oppert, Patrick Tounian, Florence Marchelli, Rohia Alili, Johanne Le Beyec, Dominique Pépin, Jean-Marc Lacorte, Andrew Gottesdiener, Rebecca Bounds, Shubh Sharma, Cathy Folster, Bart Henderson, Stephen O'Rahilly, Elizabeth Stoner, Keith Gottesdiener, Brandon L Panaro, Roger D Cone, Karine Clément, I Sadaf Farooqi, Lex H T Van der Ploeg
OBJECTIVE: Pro-opiomelanocortin (POMC)-derived peptides act on neurons expressing the Melanocortin 4 receptor (MC4R) to reduce body weight. Setmelanotide is a highly potent MC4R agonist that leads to weight loss in diet-induced obese animals and in obese individuals with complete POMC deficiency. While POMC deficiency is very rare, 1-5% of severely obese individuals harbor heterozygous mutations in MC4R. We sought to assess the efficacy of Setmelanotide in human MC4R deficiency. METHODS: We studied the effects of Setmelanotide on mutant MC4Rs in cells and the weight loss response to Setmelanotide administration in rodent studies and a human clinical trial...
October 2017: Molecular Metabolism
https://www.readbyqxmd.com/read/29030864/phase-iv-head-to-head-randomised-controlled-trial-comparing-ingenol-mebutate-0-015-gel-with-diclofenac-sodium-3-gel-for-the-treatment-of-actinic-keratosis-on-the-face-or-scalp
#17
E Stockfleth, C A Harwood, C Serra Guillén, T Larsson, M L Østerdal, T Skov
BACKGROUND: Ingenol mebutate (IngMeb) and diclofenac sodium (DS) are approved treatments for actinic keratosis (AK). OBJECTIVES: Compare efficacy and safety of IngMeb 0.015% gel with DS 3% gel. METHODS: Patients with 4-8 visible, discrete AK lesions on face/scalp in a 25 cm(2) contiguous area of skin were randomised 1:1 to IngMeb once-daily for 3 consecutive days, or DS twice-daily for 90 days, following label instruction. Patients presenting with AK lesions at Week 8 following IngMeb were offered a second IngMeb course...
October 14, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/29030354/phase-1b-2-trial-of-nc-6004-nanoparticle-cisplatin-plus-gemcitabine-in-patients-with-advanced-solid-tumors
#18
Vivek Subbiah, Juneko E Grilley-Olson, Austin Combest, Neelesh Sharma, Richard H Tran, Iulian Bobe, Atsushi Osada, Kazuhiro Takahashi, Jaikrishna Balkissoon, Aaron Camp, Atsuhiro Masada, Dirk J Reitsma, Lyudmila Bazhenova
Purpose NC-6004, a novel cisplatin nanoparticle developed using micellar technology exhibits sustained release of cisplatin and selective distribution to tumors. Preclinical data demonstrated a favorable tolerability profile and preserved or improved anti-tumor activity compared to cisplatin across animal models. We evaluated the safety and tolerability of NC-6004 and gemcitabine using a Bayesian continual reassessment model (N-CRM) to determine the optimal dose. Experimental Design Patients with advanced solid tumors received NC-6004 at 60-180mg/m2 on Day 1 and gemcitabine at 1250 mg/m2 on Days 1 and 8 every three weeks...
October 13, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29029224/immunogenicity-and-safety-of-an-adjuvanted-herpes-zoster-subunit-vaccine-co-administered-with-seasonal-influenza-vaccine-in-adults-aged-50-years-and-older
#19
Tino F Schwarz, Naresh Aggarwal, Beate Moeckesch, Isabelle Schenkenberger, Carine Claeys, Martine Douha, Olivier Godeaux, Katrijn Grupping, Thomas C Heineman, Marta Lopez Fauqued, Lidia Oostvogels, Peter Van den Steen, Himal Lal
Background: The immunogenicity and safety of an adjuvanted herpes zoster subunit vaccine (HZ/su) when co-administered with a quadrivalent seasonal inactivated influenza vaccine (IIV4) was investigated in a phase 3, open-label, randomized clinical trial in adults aged ≥50 years. Methods: Subjects were randomized 1:1 to receive either HZ/su (VZV glycoprotein E [gE]; AS01B Adjuvant System) and IIV4 at day 0 followed by a second HZ/su dose at month 2 (Co-ad group), or IIV4 at month 0 and HZ/su at months 2 and 4 (Control group)...
September 26, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29029210/lesinurad-monotherapy-in-gout-patients-intolerant-to-a-xanthine-oxidase-inhibitor-a-6-month-phase-3-clinical-trial-and-extension-study
#20
Anne-Kathrin Tausche, Rieke Alten, Nicola Dalbeth, Jeff Kopicko, Maple Fung, Scott Adler, Nihar Bhakta, Chris Storgard, Scott Baumgartner, Kenneth Saag
Objective: To investigate the efficacy and safety of lesinurad, a selective uric acid reabsorption inhibitor, in a 6 month, phase 3 clinical trial and extension study. Methods: Patients with gout who cannot take a xanthine oxidase inhibitor (XOI) and have serum uric acid (sUA) ⩾6.5 mg/dl were randomized to receive oral lesinurad (400 mg daily) or placebo. The primary endpoint was the proportion of patients with sUA <6.0 mg/dl at month 6. Safety assessments included treatment-emergent adverse events (TEAEs) and laboratory data...
September 23, 2017: Rheumatology
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