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https://www.readbyqxmd.com/read/29356022/optical-treatment-of-amblyopia-in-older-children-and-adults-is-essential-prior-to-enrolment-in-a-clinical-trial
#1
Tina Y Gao, Nicola Anstice, Raiju J Babu, Joanna M Black, William R Bobier, Shuan Dai, Cindy X Guo, Robert F Hess, Michelle Jenkins, Yannan Jiang, Lisa Kearns, Lionel Kowal, Carly S Y Lam, Peter C K Pang, Varsha Parag, Jayshree South, Sandra Elfride Staffieri, Angela Wadham, Natalie Walker, Benjamin Thompson
PURPOSE: Optical treatment alone can improve visual acuity (VA) in children with amblyopia, thus clinical trials investigating additional amblyopia therapies (such as patching or videogames) for children require a preceding optical treatment phase. Emerging therapies for adult patients are entering clinical trials. It is unknown whether optical treatment is effective for adults with amblyopia and whether an optical correction phase is required for trials involving adults. METHODS: We examined participants who underwent optical treatment in the Binocular Treatment for Amblyopia using Videogames (BRAVO) clinical trial (ANZCTR ID: ACTRN12613001004752)...
January 22, 2018: Ophthalmic & Physiological Optics: the Journal of the British College of Ophthalmic Opticians (Optometrists)
https://www.readbyqxmd.com/read/29356021/evaluation-of-fidaxomicin-usage-patterns-and-outcomes-for-clostridium-difficile-infection-across-the-united-states-veterans-health-administration
#2
S E Giancola, R J Williams, C A Gentry
WHAT IS KNOWN AND OBJECTIVE: Fidaxomicin was recently approved for the treatment of Clostridium difficile infection (CDI). Limited data on its use exist outside of the phase 3 trials. The purposes of this study were to assess the compliance with the Veterans Health Administration (VHA) fidaxomicin criteria for use and describe patient characteristics and outcomes following fidaxomicin treatment for CDI using real-world data within the VHA system. METHODS: This was a multicentre, retrospective, observational study including all adult patients who received at least 1 dose of fidaxomicin at any Veterans Affairs Medical Center...
January 21, 2018: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/29355906/antibiotic-therapy-for-preventing-infections-in-people-with-acute-stroke
#3
REVIEW
Jan-Dirk Vermeij, Willeke F Westendorp, Diederik Wj Dippel, Diederik van de Beek, Paul J Nederkoorn
BACKGROUND: Stroke is the main cause of disability in high-income countries and ranks second as a cause of death worldwide. Infections occur frequently after stroke and may adversely affect outcome. Preventive antibiotic therapy in the acute phase of stroke may reduce the incidence of infections and improve outcome. In the previous version of this Cochrane Review, published in 2012, we found that antibiotics did reduce the risk of infection but did not reduce the number of dependent or deceased patients...
January 22, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29355904/a-multi-centre-open-investigator-initiated-phase-iv-clinical-trial-to-evaluate-the-efficacy-and-safety-of-ingenol-mebutate-gel-0-015-on-the-face-and-scalp-and-0-05-on-the-trunk-and-extremities-in-korean-patients-with-actinic-keratosis-perfect
#4
Y C Kim, J Y Yang, J S Yoon, S J Jo, H H Ahn, K-H Song, D-Y Lee, K-Y Chung, Y-H Won, I-H Kim
BACKGROUND: Ingenol mebutate gel is a novel, field-directed topical treatment for actinic keratosis (AK). Most pivotal studies have targeted Western populations. No clinical study has been conducted to investigate its efficacy and safety in Asian populations. OBJECTIVES: To evaluate the efficacy and safety of ingenol mebutate gel for treating AK of face/scalp and trunk/extremities in a large Asian (Korean) population. METHODS: In this multi-centre, open-label, interventional, parallel group, prospective phase 4 study (PERFECT, NCT02716714), the eligible subjects were allocated into either the face/scalp or the trunk/extremities group, according to their selected treatment area location...
January 20, 2018: British Journal of Dermatology
https://www.readbyqxmd.com/read/29355400/clinical-efficacy-of-ribociclib-as-a-first-line-therapy-for-hr-positive-advanced-breast-cancer
#5
Bruno Achutti Duso, Dario Trapani, Giulia Viale, Carmen Criscitiello, Paolo D'Amico, Carmen Belli, Luca Mazzarella, Marzia Locatelli, Ida Minchella, Giuseppe Curigliano
Breast cancer (BC) remains the most frequently diagnosed cancer and the most common cause of cancer death among women of all races worldwide. Over 80% of BC cases are hormone receptor (HR)-positive, comprised of luminal A and luminal B per molecular subtypes, imposing an urgent need to fully understand the mechanisms behind progression. Ribociclib is a selective cycline-dependent kinase 4 and 6 inhibitor. A phase 1 and a phase 3 trial have established a definitive role of ribociclib as frontline in the treatment of endocrine-sensitive advanced BC...
January 22, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29353025/efficacy-and-safety-of-fezakinumab-an-anti-il-22-monoclonal-antibody-in-adults-with-moderate-to-severe-atopic-dermatitis-inadequately-controlled-by-conventional-treatments-a-randomized-double-blind-phase-2a-trial
#6
Emma Guttman-Yassky, Patrick M Brunner, Avidan U Neumann, Saakshi Khattri, Ana B Pavel, Kunal Malik, Giselle K Singer, Danielle Baum, Patricia Gilleaudeau, Mary Sullivan-Whalen, Sharon Rose, Shelbi Jim On, Xuan Li, Judilyn Fuentes-Duculan, Yeriel Estrada, Sandra Garcet, Claudia Traidl-Hoffmann, James G Krueger, Mark G Lebwohl
BACKGROUND: IL-22 promotes epidermal hyperplasia and inhibits skin barrier function. OBJECTIVE: Evaluate IL-22 blockade in adults with moderate-to-severe atopic dermatitis (AD). METHODS: Randomized, double-blind, placebo-controlled trial with intravenous fezakinumab monotherapy every 2wks for 10wks, with follow-up assessments until 20wks. SCORAD change from baseline at 12wks served as primary endpoint. RESULTS: At 12wks, mean SCORAD decline was 13·8±2·7 (fezakinumab) vs...
January 15, 2018: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/29352704/treatment-of-adult-chronic-indeterminate-chagas-disease-with-benznidazole-and-three-e1224-dosing-regimens-a-proof-of-concept-randomised-placebo-controlled-trial
#7
Faustino Torrico, Joaquim Gascon, Lourdes Ortiz, Cristina Alonso-Vega, María-Jesús Pinazo, Alejandro Schijman, Igor C Almeida, Fabiana Alves, Nathalie Strub-Wourgaft, Isabela Ribeiro
BACKGROUND: Chagas disease is a major neglected vector-borne disease. In this study, we investigated the safety and efficacy of three oral E1224 (a water-soluble ravuconazole prodrug) regimens and benznidazole versus placebo in adult chronic indeterminate Chagas disease. METHOD: In this proof-of-concept, double-blind, randomised phase 2 clinical trial, we recruited adults (18-50 years) with confirmed diagnosis of Trypanosoma cruzi infection from two outpatient units in Bolivia...
January 15, 2018: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29351594/sero-efficacy-of-vi-polysaccharide-tetanus-toxoid-typhoid-conjugate-vaccine-typbar-tcv
#8
Merryn Voysey, Andrew J Pollard
Background: Salmonella Typhi is the major cause of enteric fever in lower income countries. New conjugate vaccines show promise as public health interventions, however there are no efficacy data available from endemic areas. Methods: Data were obtained from a previously published phase 3 randomised controlled trial comparing Vi-polysaccharide tetanus-toxoid conjugate vaccine (Typbar-TCV; Bharat Biotech Intl Ltd, India): (Vi-TT) with Vi-polysaccharide (Typbar; Bharat Biotech Intl Ltd, India): (Vi-PS) in participants aged 2- 45 years...
January 17, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29351125/central-inhibition-of-granulocyte-macrophage-colony-stimulating-factor-is-analgesic-in-experimental-neuropathic-pain
#9
Louise S C Nicol, Peter Thornton, Jon P Hatcher, Colin P Glover, Carl I Webster, Matthew Burrell, Kessia Hammett, Clare A Jones, Matthew A Sleeman, Andrew Billinton, Iain Chessell
With less than 50% of patients responding to the current standard of care and poor efficacy and selectivity of current treatments, neuropathic pain continues to be an area of considerable unmet medical need. Biological therapeutics such as monoclonal antibodies (mAbs) provide better intrinsic selectivity; however, delivery to the central nervous system (CNS) remains a challenge. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is well described in inflammation-induced pain, and early-phase clinical trials evaluating its antagonism have exemplified its importance as a peripheral pain target...
January 16, 2018: Pain
https://www.readbyqxmd.com/read/29350771/recombinant-relaxin-protects-liver-transplants-from-ischemia-damage-via-hepatocyte-glucocorticoid-receptor-from-bench-to-bedside
#10
Shoichi Kageyama, Kojiro Nakamura, Takehiro Fujii, Bibo Ke, Rebecca A Sosa, Elaine F Reed, Nakul Datta, Ali Zarrinpar, Ronald W Busuttil, Jerzy W Kupiec-Weglinski
Hepatic ischemia-reperfusion injury (IRI) represents a major risk factor of early graft dysfunction and acute/chronic rejection as well as a key obstacle to expanding the donor pool in orthotopic liver transplantation (OLT). Although glucocorticoid receptor (GR) signaling may enhance cytoprotective programs, clinical use of glucocorticoid is limited due to adverse effects, while clinical relevance of GR-facilitated cytoprotection in OLT remains unknown. We aimed to evaluate the significance of hepatic GR in clinical OLT and verify the impact of recombinant human relaxin (rhRLX), which may function as GR agonist in tissue/disease-specific manner...
January 19, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29349796/quantification-of-acyclovir-in-dermal-interstitial-fluid-and-human-serum-by-ultra-high-performance-liquid-chromatography-high-resolution-tandem-mass-spectrometry-for-topical-bioequivalence-evaluation
#11
Denise Schimek, Reingard Raml, Kevin A Francesconi, Manfred Bodenlenz, Frank Sinner
Time-concentration curves for the topical anti-viral drug acyclovir can provide valuable information for drug development. Open flow microperfusion (OFM) is used for continuous sampling of dermal interstitial fluid but it requires validated methods for subsequent sample analysis. Therefore, we developed a sensitive, selective and high throughput ultra-high-performance liquid chromatography-high resolution tandem mass spectrometry (UHPLC-HR MS/MS) method to determine acyclovir in human dermal interstitial fluid and serum...
January 19, 2018: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29348926/a-double-blind-placebo-controlled-single-ascending-dose-study-of-remyelinating-antibody-rhigm22-in-people-with-multiple-sclerosis
#12
Andrew Eisen, Benjamin M Greenberg, James D Bowen, Douglas L Arnold, Anthony O Caggiano
Objective: The objective of this paper is to assess, in individuals with clinically stable multiple sclerosis (MS), the safety, tolerability, pharmacokinetics (PK) and exploratory pharmacodynamics of the monoclonal recombinant human antibody IgM22 (rHIgM22). Methods: Seventy-two adults with stable MS were enrolled in a double-blind, randomized, placebo-controlled, single ascending-dose, Phase 1 trial examining rHIgM22 from 0.025 to 2.0 mg/kg. Assessments included MRI, MR spectroscopy, plasma PK, and changes in clinical status, laboratory values and adverse events for three months...
October 2017: Multiple Sclerosis Journal—Experimental, Translational and Clinical
https://www.readbyqxmd.com/read/29347996/the-apathy-in-dementia-methylphenidate-trial-2-admet-2-study-protocol-for-a-randomized-controlled-trial
#13
Roberta W Scherer, Lea Drye, Jacobo Mintzer, Krista Lanctôt, Paul Rosenberg, Nathan Herrmann, Prasad Padala, Olga Brawman-Mintzer, William Burke, Suzanne Craft, Alan J Lerner, Allan Levey, Anton Porsteinsson, Christopher H van Dyck
BACKGROUND: Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events...
January 18, 2018: Trials
https://www.readbyqxmd.com/read/29347993/updated-efficacy-of-avelumab-in-patients-with-previously-treated-metastatic-merkel-cell-carcinoma-after-%C3%A2-1%C3%A2-year-of-follow-up-javelin-merkel-200-a-phase-2-clinical-trial
#14
Howard L Kaufman, Jeffery S Russell, Omid Hamid, Shailender Bhatia, Patrick Terheyden, Sandra P D'Angelo, Kent C Shih, Céleste Lebbé, Michele Milella, Isaac Brownell, Karl D Lewis, Jochen H Lorch, Anja von Heydebreck, Meliessa Hennessy, Paul Nghiem
BACKGROUND: Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer associated with poor survival outcomes in patients with distant metastatic disease (mMCC). In an initial analysis from JAVELIN Merkel 200, a phase 2, prospective, open-label, single-arm trial in mMCC, avelumab-a human anti-programmed death-ligand 1 (PD-L1) monoclonal antibody-showed promising efficacy and a safety profile that was generally manageable and tolerable. Here, we report the efficacy of avelumab after ≥1 year of follow-up in patients with distant mMCC that had progressed following prior chemotherapy for metastatic disease...
January 19, 2018: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29346478/differentiation-syndrome-associated-with-enasidenib-a-selective-inhibitor-of-mutant-isocitrate-dehydrogenase-2-analysis-of-a-phase-1-2-study
#15
Amir T Fathi, Courtney D DiNardo, Irina Kline, Laurie Kenvin, Ira Gupta, Eyal C Attar, Eytan M Stein, Stephane de Botton
Importance: Enasidenib mesylate, a mutant isocitrate dehydrogenase 2 (IDH2) protein inhibitor that promotes differentiation of leukemic myeloblasts, was recently approved by the US Food and Drug Administration for use in relapsed/refractory (R/R) mutant IDH2 acute myeloid leukemia (AML). During the first study of enasidenib in humans, a minority of patients with advanced myeloid neoplasms experienced unexpected signs/symptoms of a differentiation syndrome (DS), a potentially lethal entity...
January 18, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29345044/preclinical-characterisation-of-absorption-distribution-metabolism-and-excretion-properties-of-tak-063
#16
Kimio Tohyama, Miyako Sudo, Akio Morohashi, Suguru Kato, Junzo Takahashi, Yoshihiko Tagawa
TAK-063 is currently being developed to treat schizophrenia. In this study, we investigated the absorption, distribution, metabolism and excretion (ADME) properties of TAK-063 using several paradigms. Following oral administration of TAK-063 at 0.3 mg/kg, bioavailability of TAK-063 was 27.4% in rats and 49.5% in dogs with elimination half-lives of 3.1 hr in rats and 3.7 hr in dogs. TAK-063 is a highly permeable compound without P-glycoprotein (P-gp) or breast cancer resistance protein substrate liability and can be readily absorbed into systemic circulation via the intestine...
January 17, 2018: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/29343509/efficacy-and-safety-of-tregalizumab-in-patients-with-rheumatoid-arthritis-and-an-inadequate-response-to-methotrexate-results-of-a-phase-iib-randomised-placebo-controlled-trial
#17
Ronald F van Vollenhoven, Edward Clark Keystone, Vibeke Strand, Cesar Pacheco-Tena, Jiří Vencovský, Frank Behrens, Arthur Racewicz, Daniela Zipp, Faiza Rharbaoui, Ralf Wolter, Luise Knierim, Rainer Schmeidl, Xuefei Zhou, Silke Aigner, Benjamin Dälken, Andrea Wartenberg-Demand
OBJECTIVE: To evaluate the efficacy, biological activity and safety of tregalizumab in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). METHODS: 321 patients were randomised (1:1:1:1) to placebo or tregalizumab 25, 100 or 200 mg once-weekly subcutaneously in addition to MTX treatment. Responders at week 12 continued the same treatment, and non-responders at week 12 were escalated to the next higher tregalizumab dose level or re-randomised from placebo to active treatment...
January 17, 2018: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/29343266/identification-of-pain-categories-associated-with-change-in-pain-in-patients-receiving-placebo-data-from-two-phase-3-randomized-clinical-trials-in-symptomatic-knee-osteoarthritis
#18
Asger Reinstrup Bihlet, Inger Byrjalsen, Anne-Christine Bay-Jensen, Jeppe Ragnar Andersen, Claus Christiansen, Bente Juel Riis, Ivo Valter, Morten A Karsdal, Marc C Hochberg
BACKGROUND: Pain is the principal clinical symptom of osteoarthritis (OA), and development of safe and effective analgesics for OA pain is needed. Drug development of new analgesics for OA pain is impaired by substantial change in pain in patients receiving placebo, and more data describing clinical characteristics and pain categories particularly associated with this phenomenon is needed. The purpose of this post-hoc analysis was to investigate clinical characteristics and pain categories and their association with radiographic progression and placebo pain reduction (PPR) in OA patients as measured the Western Ontario and McMasters Arthritis (WOMAC)...
January 17, 2018: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/29343142/a-500%C3%A2-u-2%C3%A2-ml-dilution-of-abobotulinumtoxina-vs-placebo-randomized-study-in-cervical-dystonia
#19
Mark F Lew, Allison Brashear, Khashayar Dashtipour, Stuart Isaacson, Robert A Hauser, Pascal Maisonobe, Daniel Snyder, William Ondo
Purpose/aim: AbobotulinumtoxinA (Dysport®, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ, USA) is an acetylcholine release inhibitor and a neuromuscular blocking agent. The United States prescribing information for abobotulinumtoxinA previously indicated only one dilution for cervical dystonia: 500 U/1 mL. Clinical trial data supporting a larger volume with a 500 U/2 mL dilution would offer clinicians flexibility with injection volume to better meet patient needs. MATERIALS AND METHODS: We conducted a 12-week, phase 3b, multicenter, randomized, double-blind, placebo-controlled trial (NCT01753310)...
January 17, 2018: International Journal of Neuroscience
https://www.readbyqxmd.com/read/29342285/serial-participation-and-the-ethics-of-phase-1-healthy-volunteer-research
#20
Rebecca L Walker, Marci D Cottingham, Jill A Fisher
Phase 1 healthy volunteer clinical trials-which financially compensate subjects in tests of drug toxicity levels and side effects-appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase 1 trials...
January 12, 2018: Journal of Medicine and Philosophy
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