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SPIRIT and CONSORT extensions for early phase dose-finding clinical trials
Aude Espinasse, Olga Solovyeva, Munyaradzi Dimairo, Christopher Weir, Thomas Jaki, Adrian Mander, Andrew Kightley, Jeffry Evans, Shing Lee, Alun Bedding, Sally Hopewell, Khadija Rantell, Rong Liu, An-Wen Chan, Johann De Bono, Christina Yap
Apr 17, 2023
INTRODUCTION: Early phase dose-finding (EPDF) studies are critical for the development of new treatments, directly influencing whether compounds or interventions can be investigated in further trials to confirm their safety and...
The underlying structure of visuospatial working memory in children with mathematical learning disability.
This study examined visual, spatial-sequential, and spatial-simultaneous working memory (WM) performance in children with mathematical learning disability (MLD) and low mathematics achievement (LMA) compared with typically...
Intermittent schedules of the oral RAF-MEK inhibitor CH5126766/VS-6766 in patients with RAS/RAF-mutant solid tumours and multiple myeloma
Christina Guo, Maxime Chénard-Poirier, Desamparados Roda, Maria de Miguel, Samuel J Harris, Irene Moreno Candilejo, Priya Sriskandarajah, Wen Xu, Mariana Scaranti, Anastasia Constantinidou, Jenny King, Mona Parmar, Alison J Turner, Suzanne Carreira, Ruth Riisnaes, Laura Finneran, Emma Hall, Yuji Ishikawa, Kiyohiko Nakai, Nina Tunariu, Bristi Basu, Martin Kaiser, Juanita Suzanne Lopez, Anna Minchom, Johann S de Bono, Udai Banerji
Oct 29, 2020
BACKGROUND: CH5126766 (also known as VS-6766, and previously named RO5126766), a novel MEK-pan-RAF inhibitor, has shown antitumour activity across various solid tumours; however, its initial development was limited by toxicity....
Comparative analysis of high dose methyldopa and low dose methyldopa with nifedipine in terms of blood pressure in cases of pregnancy induced hypertension
Objective: Comparison between Methyldopa and combination of Methyldopa and Nifedipine in terms of mean change in blood pressure in pregnancy induced hypertension.
Material and methods: This randomized controlled was conducted...
Diastolic blood pressure Methyldopa Nifedipine Pregnancy induced hypertension Systolic blood pressure
Published by: IJHS Medical Association
Dose finding studies for therapies with late-onset toxicities
An objective of phase I dose-finding trials is to find the maximum tolerated dose; the dose with a particular risk of toxicity. Frequently, this risk is assessed across the first cycle of therapy. However, in oncology, a course...
Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS)
Tian Xiao Zhao, Michalis Kostapanos, Charmaine Griffiths, Emma L Arbon, Annette Hubsch, Fotini Kaloyirou, Joanna Helmy, Stephen P Hoole, James HF Rudd, Graham Wood, Keith Burling, Simon Bond, Joseph Cheriyan, Ziad Mallat
Nov 07, 2018
INTRODUCTION: Inflammation and dysregulated immune responses play a crucial role in atherosclerosis, underlying ischaemic heart disease (IHD) and acute coronary syndromes (ACSs). Immune responses are also major determinants of...
Acute Coronary Syndrome aldesleukin interleukin 2 ischaemic heart disease Regulatory T cells Acute Coronary Syndrome C-Reactive Protein Clinical Trials Phase I as Topic Clinical Trials Phase II as Topic Double-Blind Method Humans Immunologic Factors Interleukin-2 Interleukin-6 Lymphocyte Count Myocardial Ischemia Natriuretic Peptide Brain Randomized Controlled Trials as Topic Recombinant Proteins T-Lymphocytes Regulatory Troponin
Blood Pressure Changes Following Antihypertensive Medication Reduction, by Drug Class and Dose Chosen for Withdrawal
James P. Sheppard, Mark Lown, Jenni Burt, Gary A. Ford, F. D. Richard Hobbs, Paul Little, Jonathan Mant, Rupert A. Payne, Richard J. McManus, On behalf of the OPTiMISE Investigators
May 04, 2021
Aims: Deprescribing of antihypertensive drugs is recommended for some older patients with polypharmacy, but there is little evidence to inform which drug (or dose) should be withdrawn. This study used data from the OPTiMISE...
Comparative analysis of high dose methyldopa and low dose methyldopa with nifedipine in terms of blood pressure in cases of pregnancy induced hypertension
Objective: Comparison between Methyldopa and combination of Methyldopa and Nifedipine in terms of mean change in blood pressure in pregnancy induced hypertension.
Material and methods: This randomized controlled was conducted...
Diastolic blood pressure Methyldopa Nifedipine Pregnancy induced hypertension Systolic blood pressure
Published by: IJHS Medical Association
Neutron Radiation Dose Measurements in a Scanning Proton Therapy Room
Vladimir Mares, Jad Farah, Marijke De Saint-Hubert, Szymon Domański, Carles Domingo, Martin Dommert, Magdalena Kłodowska, Katarzyna Krzempek, Michał Kuć, Immaculada Martínez-Rovira, Edyta Michaś, Natalia Mojżeszek, Łukasz Murawski, Ondrej Ploc, Maite Romero-Expósito, Marco Tisi, François Trompier, Olivier Van Hoey, Laurent Van Ryckeghem, Marek Wielunski, Roger M Harrison, Liliana Stolarczyk, Pawel Olko
Jul 28, 2022
PURPOSE: This study aims to characterize the neutron radiation field inside a scanning proton therapy treatment room including the impact of different pediatric patient sizes. MATERIALS AND METHODS: Working Group 9 of the...
Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST)
Alasdair PS Munro, Shuo Feng, Leila Janani, Victoria Cornelius, Parvinder K Aley, Gavin Babbage, David Baxter, Marcin Bula, Katrina Cathie, Krishna Chatterjee, Kate Dodd, Yvanne Enever, Ehsaan Qureshi, Anna L Goodman, Christopher A Green, Linda Harndahl, John Haughney, Alexander Hicks, Agatha A van der Klaauw, Nasir Kanji, Vincenzo Libri, Martin J Llewelyn, Alastair C McGregor, Mina Maallah, Angela M Minassian, Patrick Moore, Mehmood Mughal, Yama F Mujadidi, Kyra Holliday, Orod Osanlou, Rostam Osanlou, Daniel R Owens, Mihaela Pacurar, Adrian Palfreeman, Daniel Pan, Tommy Rampling, Karen Regan, Stephen Saich, Tanveer Bawa, Dinesh Saralaya, Sunil Sharma, Ray Sheridan, Emma C Thomson, Shirley Todd, Chris Twelves, Robert C Read, Sue Charlton, Bassam Hallis, Mary Ramsay, Nick Andrews, Teresa Lambe, Jonathan S Nguyen-Van-Tam, Matthew D Snape, Xinxue Liu, Saul N Faust, COV-BOOST study group
Jun 13, 2022
BACKGROUND: Some high-income countries have deployed fourth doses of COVID-19 vaccines, but the clinical need, effectiveness, timing, and dose of a fourth dose remain uncertain. We aimed to investigate the safety...
Datasets of in vitro clonogenic assays showing low dose hyper-radiosensitivity and induced radioresistance.
Low dose hyper-radiosensitivity and induced radioresistance are primarily observed in surviving fractions of cell populations exposed to ionizing radiation, plotted as the function of absorbed dose. Several biophysical models...
Automatic prioritization of self-referential stimuli in working memory
People preferentially attend to external stimuli that are related to themselves compared with others. Whether a similar self-reference bias applies to internal representations, such as those maintained in working memory (WM), is...
Retrospective methods to estimate radiation dose at the site of breast cancer development after Hodgkin lymphoma radiotherapy.
Nicola S Russell, Inge M Krul, Anna M van Eggermond, Berthe MP Aleman, Rosie Cooke, Susanne Kuiper, Steven D Allen, Matthew G Wallis, Damien Llanas, Ibrahima Diallo, Florent de Vathaire, Susan A Smith, Michael Hauptmann, Annegien Broeks, Anthony J Swerdlow, Flora E van Leeuwen
Feb 23, 2018
BACKGROUND: An increased risk of breast cancer following radiotherapy for Hodgkin lymphoma (HL) has now been robustly established. In order to estimate the dose-response relationship more accurately, and to aid clinical decision...
A phase 1, single-dose study of fresolimumab, an anti-TGF-β antibody, in treatment-resistant primary focal segmental glomerulosclerosis.
Howard Trachtman, Fernando C Fervenza, Debbie S Gipson, Peter Heering, David RW Jayne, Harm Peters, Stefano Rota, Giuseppe Remuzzi, L Christian Rump, Lorenz K Sellin, Jeremy PW Heaton, James B Streisand, Marjie L Hard, Steven R Ledbetter, Flavio Vincenti
Nov 24, 2020
Primary focal segmental glomerulosclerosis (FSGS) is a disease with poor prognosis and high unmet therapeutic need. Here, we evaluated the safety and pharmacokinetics of single-dose infusions of fresolimumab, a human monoclonal...
Adult Antibodies Monoclonal Antibodies Monoclonal Humanized Biomarkers Biopsy Creatinine Dose-Response Relationship Drug Europe Female Glomerular Filtration Rate Glomerulosclerosis Focal Segmental Humans Infusions Parenteral Kidney Male Middle Aged Proteinuria Transforming Growth Factor beta Treatment Outcome United States Young Adult
Positioning imatinib for pulmonary arterial hypertension
Martin R Wilkins, Mikel A Mckie, Martin Law, Andreas A Roussakis, Lars Harbaum, Colin Church, J Gerry Coghlan, Robin Condliffe, Luke S Howard, David G Kiely, Jim Lordan, Alexander Rothman, Jay Suntharalingam, Mark Toshner, Stephen J Wort, Sofía S Villar
Oct 18, 2021
Pulmonary arterial hypertension is an unmet clinical need. Imatinib, a tyrosine kinase inhibitor, 200 to 400 mg daily reduces pulmonary artery pressure and increases functional capacity in this patient group, but is generally...
A Combined Li Intercalation and Plating Mechanism Using Conductive Carbon Fiber Electrodes
Lithium metal anodes (LMAs) are desirable for next-generation rechargeable batteries because of their high energy density. However, in practical applications they are hindered by inhomogeneous and uncontrolled Li dendrite...
Interventions targeting working memory in 4-11 year olds within their everyday contexts
It has been suggested that diverse interventions applied within children's everyday contexts have the potential to improve working memory (WM) and produce transfer to real-world skills but little is known about the effectiveness...
Positioning imatinib for pulmonary arterial hypertension
Martin R Wilkins, Mikel A Mckie, Martin Law, Andreas A Roussakis, Lars Harbaum, Colin Church, J Gerry Coghlan, Robin Condliffe, Luke S Howard, David G Kiely, Jim Lordan, Alexander Rothman, Jay Suntharalingam, Mark Toshner, Stephen J Wort, Sofía S Villar
Jan 28, 2022
Pulmonary arterial hypertension is an unmet clinical need. Imatinib, a tyrosine kinase inhibitor, 200 to 400 mg daily reduces pulmonary artery pressure and increases functional capacity in this patient group, but is generally...
Single-dose BNT162b2 vaccine protects against asymptomatic SARS-CoV-2 infection.
Nick K Jones, Lucy Rivett, Shaun Seaman, Richard J Samworth, Ben Warne, Chris Workman, Mark Ferris, Jo Wright, Natalie Quinnell, Ashley Shaw, Cambridge COVID-19 Collaboration, Ian G Goodfellow, Paul J Lehner, Rob Howes, Giles Wright, Nicholas J Matheson, Michael P Weekes
Apr 09, 2021
The BNT162b2 mRNA COVID-19 vaccine (Pfizer-BioNTech) is being utilised internationally for mass COVID-19 vaccination. Evidence of single-dose protection against symptomatic disease has encouraged some countries to opt for...
Single-dose BNT162b2 vaccine protects against asymptomatic SARS-CoV-2 infection
Nick K Jones, Lucy Rivett, Shaun Seaman, Richard J Samworth, Ben Warne, Chris Workman, Mark Ferris, Jo Wright, Natalie Quinnell, Ashley Shaw, Cambridge COVID-19 Collaboration, Ian G Goodfellow, Paul J Lehner, Rob Howes, Giles Wright, Nicholas J Matheson, Michael P Weekes, Amy Amory, Stephen Baker, Emma Bateman, Aklima Begum, Moushima Begum, John Bradley, Michael Brennan, Helen Burn, Caroline Crofts, Afzal Chaudhry, Yasmin Chaudhry, Daniel J Cooper, Sharon Dawson, Gordon Dougan, Renny Feather, Louise Free, Katie Friel, Claire Gildea, Iliana Georgana, Lizz Grimwade, Ravi Gupta, Susan Hall, Sophie Hannan, James Hayes, Aleksandra Hosaja, Myra Hosmillo, Rhys Izuagbe, Aminu Jahun, Lidia James, Jill Jardin, Nathalie Kingston, Sara Lear, Paul A Lyons, Patrick H Maxwell, Sue Mott, Sarah Mugavin, Joyce Mwiya, Sharon Peacock, Ravi Prakash Nallattil, Kazeem Oloyede, Willem H Ouwehand, Elle Page, Marina Perez, Tim Raine, Matthew Routledge, Caroline Saunders, Kenneth GC Smith, Dominic Sparkes, Maria Stafford, Charlotte Summers, Despiona Tatsi, James ED Thaventhiran, Sharon Thomas Johnson, M Estée Török, Mark Toshner, Lesley Turner, Kate Wall, Karis Watson
Apr 23, 2021
The BNT162b2 mRNA COVID-19 vaccine (Pfizer-BioNTech) is being utilised internationally for mass COVID-19 vaccination. Evidence of single-dose protection against symptomatic disease has encouraged some countries to opt for...
Low-dose thiamine supplementation of lactating Cambodian mothers improves human milk thiamine concentrations
Jelisa Gallant, Kathleen Chan, Tim J Green, Frank T Wieringa, Shalem Leemaqz, Rem Ngik, Jeffrey R Measelle, Dare A Baldwin, Mam Borath, Prak Sophonneary, Lisa N Yelland, Daniela Hampel, Setareh Shahab-Ferdows, Lindsay H Allen, Kerry S Jones, Albert Koulman, Damon A Parkington, Sarah R Meadows, Hou Kroeun, Kyly C Whitfield
Apr 19, 2021
BACKGROUND: Infantile beriberi-related mortality is still common in South and Southeast Asia. Interventions to increase maternal thiamine intakes, and thus human milk thiamine, are warranted; however, the required dose remains...
How to design a dose-finding study using the continual reassessment method.
Graham M Wheeler, Adrian P Mander, Alun Bedding, Kristian Brock, Victoria Cornelius, Andrew P Grieve, Thomas Jaki, Sharon B Love, Lang'o Odondi, Christopher J Weir, Christina Yap, Simon J Bond
Feb 25, 2019
INTRODUCTION: The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM has been shown to be more accurate in targeting the...
A dose-finding design for dual-agent trials with patient-specific doses for one agent with application to an opiate detoxification trial.
There is a growing interest in early phase dose-finding clinical trials studying combinations of several treatments. While the majority of dose finding designs for such setting were proposed for oncology trials, the...
A systematic review examining the characteristics of users of NHS patient medicines helpline services, and the types of enquiries they make
Background and objective: Patient medicines helpline services (PMHS) are available from some National Health Service Trusts in the United Kingdom to support patients following discharge. The aim of this systematic review was to...
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