343,706 results match your criteria trials treatments


Outcomes of patients with solid tumour malignancies treated with first-line immuno-oncology agents who do not meet eligibility criteria for clinical trials.

Eur J Cancer 2021 May 8;151:115-125. Epub 2021 May 8.

Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada. Electronic address:

Background: Immuno-oncology (IO)-based therapies have been approved based on randomised clinical trials, yet a significant proportion of real-world patients are not represented in these trials. We sought to compare the outcomes of trial-ineligible vs. -eligible patients with advanced solid tumours treated with first-line (1L) IO therapy. Read More

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The impacts of egg storage time and maternal dietary vitamin E on the growth performance and antioxidant capacity of progeny chicks.

Poult Sci 2021 Mar 21;100(6):101142. Epub 2021 Mar 21.

Institute of Animal Nutrition, Key Laboratory for Animal Disease-Resistance Nutrition of China Ministry of Education, Animal nutrition and feed Engineering Key Laboratory of Sichuan Province, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China. Electronic address:

Two trials were designed to investigate the impacts of egg storage time and maternal dietary vitamin E (VE) supplementation on the growth performance and antioxidant capacity of progeny chicks. In total 512 Ross 308 broiler breeder hens (71-wk-old) were assigned to 2 dietary VE treatments (6 and 100 mg/kg) for 14 wk. Progeny chicks used in trials 1 and 2 were originated from eggs laid at week 10 (stored 0 d) and week 8 (stored 14 d), and week 14 (stored 0 d) and week 12 (stored 14 d), respectively. Read More

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IMPACT OF THE PLACEBO EFFECT ON SYMPTOMS, QUALITY OF LIFE AND FUNCTIONAL OUTCOMES IN ANGINA PECTORIS: A meta-analysis of randomized placebo-controlled trials.

Can J Cardiol 2021 May 8. Epub 2021 May 8.

Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, Torino.

Background: The placebo effect is a well described phenomenon in blinded studies evaluating anti-anginal therapeutics, although its impact on clinical research metrics remains unknown. We conducted a systematic review and meta-analysis to quantify the impact of placebo on endpoints of symptoms, life-quality and functional outcomes in randomized placebo-controlled trials (RCTs) of symptomatic stable coronary artery disease.

Methods: We systematically reviewed MEDLINE, EMBASE, and the Cochrane database for double-blind RCTs of anti-angina therapeutics. Read More

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Participation of Black Americans in Cancer Clinical Trials: Current Challenges and Proposed Solutions.

JCO Oncol Pract 2021 May;17(5):265-271

Department of Hematology and Oncology, Baylor College of Medicine, Houston, TX.

Low participation of Black Americans in cancer clinical trials is a well-established predicament. Many factors resulted in this current dilemma with racism being the fundamental unit. Here, we discuss some current challenges and proposed solutions to help in increasing the enrollment of Black Americans in cancer clinical trials. Read More

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Voluntary and magnetically evoked muscle contraction protocol in males with Duchenne muscular dystrophy: safety, feasibility, reliability, and validity.

Muscle Nerve 2021 May 11. Epub 2021 May 11.

Division of Rehabilitation Science, Department of Rehabilitation Medicine, Medical School-University of Minnesota, Minneapolis, MN.

Introduction: Clinical trials addressing treatments for Duchenne muscular dystrophy (DMD) require reliable and valid measurement of muscle contractile function across all disease severity levels. This work aimed to evaluate a protocol combining voluntary and evoked contractions to measure strength and excitability of wrist extensor muscles, for safety, feasibility, reliability, and discriminant validity between males with DMD and controls.

Methods: Wrist extensor muscle strength and excitability were assessed in males with DMD (N=10; mean 15. Read More

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Monoclonal Antibodies vs COVID-19: Eduardo Ojito-Magaz MS General Director, Molecular Immunology Center.

MEDICC Rev 2021 Apr 30;23(2):12. Epub 2021 Apr 30.

Cuba has five COVID-19 vaccines in clinical trials and is on track to receive emergency use authorization from the country's regulatory agency to begin mass vaccination with two of those candidates: Abdala and SOBERANA 02. Results from phase 1 and 2 trials of these vaccines, the first developed and produced in Latin America, have been encouraging, both in terms of safety and immunogenicity. The ongoing phase 3 trials will continue to look at safety, together with efficacy; parallel intervention studies involving over a million people in Havana will begin generating data on effectiveness. Read More

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Efficacy and safety of add-on tiotropium in the management of uncontrolled asthma: a patient case series.

J Asthma 2021 May 11:1-6. Epub 2021 May 11.

Allergy Immunology & Asthma Medical Group, Inc, CA, USA.

Objective: Despite the availability of various treatment options, a large proportion of patients with asthma have uncontrolled asthma in the United States. Consequently, the economic burden of suboptimal asthma control is anticipated to substantially grow in the next 20 years, adversely impacting patients' quality of life. Therefore, there is an urgent need for effective treatments to achieve and maintain asthma control. Read More

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Extrapolation and dosing recommendations for raxibacumab in children from birth to < 18 years of age.

Br J Clin Pharmacol 2021 May 11. Epub 2021 May 11.

Clinical Pharmacology and Therapeutics Group, University College London, UK.

Aim: The US Food and Drug Administration's Animal Rule allows for the approval of drugs when human efficacy studies are not ethical. While the therapeutic doses of raxibacumab, a monoclonal antibody for the prophylaxis and treatment of inhalational anthrax, have been based on pharmacokinetic data from adult subjects, its disposition in children has not been evaluated in clinical trials. Here we evaluate the effect of demographic covariates on the pharmacokinetic disposition of raxibacumab and explore opportunities for the optimization of the paediatric doses. Read More

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Genitourinary symptoms in women with breast cancer: what do oncology health professionals think and do about them?

Breast Cancer 2021 May 11. Epub 2021 May 11.

NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.

Objectives: We aimed to improve understanding of health professional knowledge and management of genitourinary symptoms (GUS) in women with early breast cancer (EBC).

Methods: A survey was sent to 872 health professionals caring for women with EBC. Questions addressed most common GUS seen, experience treating GUS, and attitudes to treatment options. Read More

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Deliberations about clinical pharmacogenetic testing in pediatric oncology.

Per Med 2021 May 11. Epub 2021 May 11.

Department of Pediatrics & BC Children's Hospital Research Institute, Division of Translational Therapeutics, University of British Columbia, Vancouver, BC V6H 3V4, Canada.

This article summarizes the background, content and outcomes of a special meeting that was convened among oncologists and scientists to discuss the role of pharmacogenetic (PGx) testing in pediatric clinical oncology practice. This meeting provided an opportunity for what the lead author (AM Issa) refers to as the 'voice of the clinician' dynamic to be amplified in order to better understand how personalized or precision medicine applications such as PGx testing are adopted and incorporated into clinical settings and what we can learn from the experiences of current and ongoing implementation PGx approaches to further the implementation of precision medicine applications in real-world environments. Group dynamics and clinical experience with PGx testing and return of results shaped the discussion. Read More

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Preclinical studies conducted on nanozyme antioxidants: shortcomings and challenges based on US FDA regulations.

Nanomedicine (Lond) 2021 May 11. Epub 2021 May 11.

Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.

The wide prevalence of oxidative stress-induced diseases has led to a growing demand for antioxidant therapeutics worldwide. Nanozyme antioxidants are drawing enormous attention as practical alternatives for conventional antioxidants. The considerable body of research over the last decade and the promising results achieved signify the potential of nanozyme antioxidants to secure a place in the expanding market of antioxidant therapeutics. Read More

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Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder and Major Depression: Comparing Commonly Used Clinical Protocols.

J Trauma Stress 2021 May 11. Epub 2021 May 11.

VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Healthcare System, Providence, Rhode Island, USA.

Transcranial magnetic stimulation (TMS) is increasingly being used to treat posttraumatic stress disorder (PTSD) comorbid with major depressive disorder (MDD). Yet, identifying the most effective stimulation parameters remains an active area of research. We recently reported on the use of 5 Hz TMS to reduce PTSD and MDD symptoms. Read More

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Population pharmacokinetics of raxibacumab in healthy adult subjects.

Br J Clin Pharmacol 2021 May 11. Epub 2021 May 11.

Clinical Pharmacology and Therapeutics Group, University College London, London, UK.

Aim: Raxibacumab is a fully humanized monoclonal antibody that blocks the interaction of Bacillus anthracis toxins, thereby protecting target cells from its effects. Raxibacumab is approved in the USA for the treatment of adults and children with inhalational anthrax in combination with antibiotics, and for prophylaxis of inhalational anthrax. The aim of this investigation was to characterise the population pharmacokinetics and assess the effect of baseline demographic covariates on the disposition of raxibacumab. Read More

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Treatment of epilepsy for people with Alzheimer's disease.

Cochrane Database Syst Rev 2021 May 11;5:CD011922. Epub 2021 May 11.

Department of Geriatric Neurology, Chinese PLA General Hospital, Beijing, China.

Background: Any type of seizure can be observed in Alzheimer's disease. Antiepileptic drugs seem to prevent the recurrence of epileptic seizures in most people with Alzheimer's disease. There are pharmacological and non-pharmacological treatments for epilepsy in people with Alzheimer's disease, however there are no current systematic reviews to evaluate the efficacy and tolerability of these treatments. Read More

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A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.

Menopause 2021 May 10. Epub 2021 May 10.

Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University. Melbourne, Australia School of Nursing, Indiana University, Indianapolis, IN Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL Red Hot Mamas North America, Inc., New York, NY Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY Department of Obstetrics and Gynaecology, University Hospitals Dorset NHS Trust, Poole, Dorset, UK Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University London, UK Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia Department of Reproductive and Maternal Medicine, School of Medicine, University of Glasgow, Glasgow, UK Departments of Psychiatry, Psychology and Obstetrics and Gynecology, University of Illinois at Chicago, Chicago IL Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, University of Pavia, Pavia, Italy Department of Urology, UIC College of Medicine, Chicago IL Queen Charlotte's and Chelsea and Westminster Hospitals, Imperial College London, London, UK Auckland District Health Board, Auckland, New Zealand Department of Obstetrics and Gynecology, Midlife Women's Health Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA Department of Obstetrics and Gynecology, George Washington University, Washington, DC Department of Obstetrics and Gynecology, University Clinic Inselspital Bern, Bern, Switzerland Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada.

Objective: Genitourinary symptoms, such as vaginal dryness and pain with sex, are commonly experienced by postmenopausal women. Comparing treatments for these genitourinary symptoms are restricted by the use of different outcome measures in clinical trials and the omission of outcomes, which may be relevant to women. The aim of this project was to develop a Core Outcome Set (COS) to be reported in clinical trials of treatments for genitourinary symptoms associated with menopause. Read More

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Outcomes of Balloon Angioplasty and Stenting for Symptomatic Intracranial Atherosclerotic Stenosis at a High Volume Center.

Acta Neurochir Suppl 2021 ;132:63-67

Department of Strokology, Stroke Center, St. Marianna University Toyoko Hospital, Kawasaki, Japan.

Purpose: This study investigated the periprocedural complication rates, long-term outcome, and restenosis of endovascular treatment for intracranial atherosclerotic stenosis (ICS) at our hospital.

Methods: We retrospectively analyzed the clinical data of 217 patients comprising 256 endovascular treatments for high-grade symptomatic ICS. The lesion was located in the internal carotid artery in 77, the middle cerebral artery in 111, the basilar artery in 29, and the vertebral artery in 39. Read More

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January 2021

Interventions for Demodex blepharitis and their effectiveness: A systematic review and meta-analysis.

Cont Lens Anterior Eye 2021 May 7:101453. Epub 2021 May 7.

Grupo de Investigación Biomedicina, Faculty of Medicine, Fundacion Universitaria Autonoma de las Americas, Pereira, Risaralda, Colombia.

Purpose: A systematic review and meta-analysis was performed to evaluate the effectiveness of interventions in the treatment ofDemodex blepharitis in adult patients.

Methods: A systematic review and meta-analysis of studies reporting the efficacy of treatments forDemodex blepharitis in the main databases (PubMed / Scopus / Cochrane / EMBASE / Science Direct / WOS / Scielo / Google Scholar / metaRegister of Controlled Trials / ClinicalTrials.gov/ WHO ICTRP) until November 24, 2020 was performed according to the PRISMA statement for meta-analysis. Read More

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Effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): study protocol for a randomized, double-blind, placebo-controlled trial.

Trials 2021 May 10;22(1):338. Epub 2021 May 10.

Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.

Background: Bilberries from Sweden, rich in polyphenols, have shown cholesterol-lowering effects in small studies, and the cholesterol-lowering properties of oats, with abundant beta-glucans and potentially bioactive phytochemicals, are well established. Both may provide cardiometabolic benefits following acute myocardial infarction (AMI), but large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects. No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors. Read More

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Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants in Pediatric Venous Thromboembolism Treatment and Thromboprophylaxis: A Systematic Review of the Literature.

Semin Thromb Hemost 2021 May 10. Epub 2021 May 10.

Johns Hopkins All Children's Institute for Clinical and Translational Research, St. Petersburg, Florida.

Venous thromboembolism (VTE) in children can lead to significant morbidity and mortality. Traditionally, treatment for thrombotic events in pediatric patients has been limited mainly to unfractionated heparin, low-molecular-weight heparin (LMWH), or vitamin K antagonists. Since the first non-vitamin K antagonist oral anticoagulant (NOAC) was approved for adult use, these agents have gained popularity for a variety of indications. Read More

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Arterial Thrombosis in Patients with Antiphospholipid Syndrome: A Review and Meta-Analysis.

Semin Thromb Hemost 2021 May 10. Epub 2021 May 10.

Department of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada.

There is a scarcity of high-quality randomized controlled trials (RCTs) comparing antithrombotic regimens for secondary prevention of arterial thrombosis (AT) in antiphospholipid syndrome (APS). We reviewed different antithrombotic regimens used for this purpose. We searched for studies on management of AT in APS on PubMed and Web of Science. Read More

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Patient Experiences of Postinfectious Olfactory Dysfunction.

ORL J Otorhinolaryngol Relat Spec 2021 May 10:1-5. Epub 2021 May 10.

Fifth Sense, Phoenix Business Centre, Unit 8, Barrow-in-Furness, United Kingdom.

Introduction: To highlight the importance of the need for new treatment modalities, this study aimed to characterise the experience of patients with postinfectious olfactory dysfunction (PIOD) in terms of the treatment they received.

Methods: An online survey was hosted by the Norwich Clinical Trials Unit on the secure REDCap server. Members of the charity Fifth Sense (the UK charity that represents and supports people affected by smell and taste disorders) were invited to participate. Read More

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Non-parameningeal head and neck rhabdomyosarcoma in children, adolescents, and young adults: Experience of the European paediatric Soft tissue sarcoma Study Group (EpSSG) - RMS2005 study.

Eur J Cancer 2021 May 7;151:84-93. Epub 2021 May 7.

SIREDO Oncology Center, Institute Curie, PSL University, Paris, France.

Background/objectives: The primary aim of this study was to analyse and evaluate the impact of different local treatments on the pattern of relapse in children with primary head and neck non-parameningeal (HNnPM) rhabdomyosarcoma (RMS), treated in the European paediatric Soft tissue sarcoma Study Group (EpSSG) RMS2005 study. The secondary aim was to assess whether current risk stratification is valid for this specific site.

Design/methods: This study includes all patients with localised HNnPM RMS enrolled in the RMS2005 study between 2005 and 2016. Read More

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Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

Lancet 2021 May 7. Epub 2021 May 7.

Research, Aurinia Pharmaceuticals, Victoria, BC, Canada. Electronic address:

Background: Voclosporin, a novel calcineurin inhibitor approved for the treatment of adults with lupus nephritis, improved complete renal response rates in patients with lupus nephritis in a phase 2 trial. This study aimed to evaluate the efficacy and safety of voclosporin for the treatment of lupus nephritis.

Methods: This multicentre, double-blind, randomised phase 3 trial was done in 142 hospitals and clinics across 27 countries. Read More

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Public availability of results of ClinicalTrials.gov-registered expanded access studies.

Br J Clin Pharmacol 2021 May 10. Epub 2021 May 10.

Laboratory of Bacteriophages, Ludwik Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences, Rudolfa Weigla Str. 12, 53-114, Wrocław, Poland.

Aim: Expanded access is the use of investigational treatments outside of clinical trials. Results of expanded access studies provide insights into how investigational treatments work in real-world settings. The objective of this study was to evaluate public availability of results of expanded access studies. Read More

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Treatments for unruptured intracranial aneurysms.

Cochrane Database Syst Rev 2021 May 10;5:CD013312. Epub 2021 May 10.

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Unruptured intracranial aneurysms are relatively common lesions in the general population, with a prevalence of 3.2%, and are being diagnosed with greater frequency as non-invasive techniques for imaging of intracranial vessels have become increasingly available and used. If not treated, an intracranial aneurysm can be catastrophic. Read More

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Safety and Efficacy of Immune Checkpoint Inhibitors in Children and Young Adults with Haematological Malignancies: Review and Future Perspectives.

Cardiovasc Hematol Agents Med Chem 2021 May 10. Epub 2021 May 10.

2nd Department of Paediatrics, Childhood and Adolescent Hematology Oncology Unit, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, AHEPA Hospital, Thessaloniki, Greece.

Despite the marked improvement in overall survival rates of paediatric patients with haematological malignancies that has been achieved during the last decades, there is still a pressing need for novel therapeutic approaches for the subset of patients with relapsed or refractory disease. Immune checkpoint inhibitors aim to induce potent anti-tumour immune responses by targeted blockade of inhibitory receptors and have shown great promise in preclinical models and studies in the adult population. However, paediatric malignancies present unique features and so far, experience with these agents remains limited. Read More

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Extension in the approaches to treat cancer through siRNA system: a beacon of hope in cancer therapy.

Drug Deliv Transl Res 2021 May 10. Epub 2021 May 10.

Department of Biotechnology, School of Basic and Applied Sciences, Shri Guru Ram Rai University, Patel Nagar, Dehradun, 248001, Uttarakhand, India.

Along with the evolutionary breakthrough of RNA interference and the applicability for gene knockdown, a subsequent development in siRNA-based therapeutics has been attained. The gene therapy based on RNAi is in transition progress from the research aspects to clinical base. Being a potent tool, siRNA is used as therapeutic against several disorders. Read More

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Nutraceuticals and Behavioral Therapy for Headache.

Curr Neurol Neurosci Rep 2021 May 10;21(7):33. Epub 2021 May 10.

Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.

Purpose Of Review: Headache affects and disables at least 1 billion people worldwide. Patients and providers seek new therapies to relieve headache without the side effects and financial burden of current treatments. This narrative review highlights recent treatment advances in integrative headache medicine: nutraceuticals and behavioral therapies. Read More

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Industry update: the latest developments in the field of therapeutic delivery, February 2021.

Authors:
Peter Timmins

Ther Deliv 2021 May 9. Epub 2021 May 9.

Department of Pharmacy, University of Huddersfield, Queensgate, Huddersfield HD1 3DH, UK.

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Adaptive Bayesian phase I clinical trial designs for estimating the maximum tolerated doses for two drugs while fully utilizing all toxicity information.

Biom J 2021 May 10. Epub 2021 May 10.

Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.

The combined treatments with multiple drugs are very common in the contemporary medicine, especially for medical oncology. Therefore, we developed a Bayesian adaptive Phase I clinical trial design entitled escalation with overdoing control using normalized equivalent toxicity score for estimating maximum tolerated dose (MTD) contour of two drug combination (EWOC-NETS-COM) used for oncology trials. The normalized equivalent toxicity score (NETS) as the primary endpoint of clinical trial is assumed to follow quasi-Bernoulli distribution and treated as quasi-continuous random variable in the logistic linear regression model which is used to describe the relationship between the doses of the two agents and the toxicity response. Read More

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