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"Drug Use"
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Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial
by
Corren, Jonathan
,
Stahl, Neil
,
Eckert, Laurent
in
Administration, Inhalation
,
Adult
,
Anti-Asthmatic Agents - administration & dosage
2016
Dupilumab, a fully human anti-interleukin-4 receptor α monoclonal antibody, inhibits interleukin-4 and interleukin-13 signalling, key drivers of type-2-mediated inflammation. Adults with uncontrolled persistent asthma who are receiving medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist require additional treatment options as add-on therapy. We aimed to assess the efficacy and safety of dupilumab as add-on therapy in patients with uncontrolled persistent asthma on medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist, irrespective of baseline eosinophil count.
We did this randomised, double-blind, placebo-controlled, parallel-group, pivotal phase 2b clinical trial at 174 study sites across 16 countries or regions. Adults (aged ≥18 years) with an asthma diagnosis for 12 months or more based on the Global Initiative for Asthma 2009 Guidelines receiving treatment with medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist were eligible for participation. Patients were randomly assigned (1:1:1:1:1) to receive subcutaneous dupilumab 200 mg or 300 mg every 2 weeks or every 4 weeks, or placebo, over a 24-week period. The primary endpoint was change from baseline at week 12 in forced expiratory volume in 1 s (FEV1 in L) in patients with baseline blood eosinophil counts of at least 300 eosinophils per μL assessed in the intention-to-treat population. Safety outcomes were assessed in all patients that received at least one dose or part of a dose of study drug. This trial is registered at ClinicalTrials.gov, number NCT01854047, and with the EU Clinical Trials Register, EudraCT number 2013-000856-16.
769 patients (158 in the placebo group and 611 in the dupilumab groups) received at least one dose of study drug. In the subgroup with at least 300 eosinophils per μL, the greatest increases (200 mg every 2 weeks, p=0·0008; 300 mg every 2 weeks, p=0·0063) in FEV1 compared with placebo were observed at week 12 with doses every 2 weeks in the 300 mg group (mean change 0·39 L [SE 0·05]; mean difference 0·21 [95% CI 0·06–0·36; p=0·0063]) and in the 200 mg group (mean change 0·43 L [SE 0·05]; mean difference 0·26 [0·11–0·40; p=0·0008]) compared with placebo (0·18 L [SE 0·05]). Similar significant increases were observed in the overall population and in the fewer than 300 eosinophils per μL subgroup (overall population: 200 mg every 2 weeks, p<0·0001; 300 mg every 2 weeks, p<0·0001; <300 eosinophils per μL: 200 mg every 2 weeks, p=0·0034; 300 mg every 2 weeks, p=0·0086), and were maintained to week 24. Likewise, dupilumab every 2 weeks produced the greatest reductions in annualised rates of exacerbation in the overall population (70–70·5%), the subgroup with at least 300 eosinophils per μL (71·2–80·7%), and the subgroup with fewer than 300 eosinophils per μL (59·9–67·6%). The most common adverse events with dupilumab compared with placebo were upper respiratory tract infections (33–41% vs 35%) and injection-site reactions (13–26% vs 13%).
Dupilumab increased lung function and reduced severe exacerbations in patients with uncontrolled persistent asthma irrespective of baseline eosinophil count and had a favourable safety profile, and hence in addition to inhaled corticosteroids plus long-acting β2-agonist therapy could improve the lives of patients with uncontrolled persistent asthma compared with standard therapy alone.
Sanofi-Genzyme and Regeneron Pharmaceuticals.
Journal Article
Substance Use in Older Adults
2024
By 2050, 85.7 million people in the United States are projected to be 65 or older. Older adults are especially prone to the effects of substances, and a 2021 survey showed that 4 million older adults were dealing with a substance use disorder. As the country's population ages, clinicians will inevitably have to care for a greater number of older adults with substance use disorders, but the literature on the topic—and the evidence base for treatment—is limited. In Substance Use in Older Adults, more than 20 contributors translate their real-world experience in geriatric psychiatry into an accessible, evidence-based guide to screening for and assessing substance use in older adults. Early chapters discuss not only etiology and epidemiology but also comorbidities and management and subsequent sections address the problematic use of specific substances, including • Alcohol• Tobacco• Opioids• Sedatives• Stimulants• Cannabinoids Readers will find guidance on safe prescribing practices for older patients, as well as an examination of the cultural and ethical issues that may arise when working with this patient population. Rife with case examples that illustrate key points in clinical practice, Substance Use in Older Adults also features numerous tables that can be referenced time and again with information on comorbidities, screening frameworks, and interventions for specific substances; stigma-reducing language; the pharmacological implications of physiological changes in older adults; and more. Clinicians from psychiatric professionals to primary care providers will benefit from exhaustive listings of additional resources. This guide also includes resources for patients, families, and caregivers that will help to strengthen the partnership between clinician and patient.
The Other Side of Cannabis
2024
Although federal law in the United States still prohibits the use, possession, and sale of cannabis containing more than 0.3% THC, 24 states, the District of Columbia, and three U.S. territories have legalized the recreational use of marijuana. This trend is also seen in other countries, including Canada, South Africa, and Uruguay. Studies show that the prevalence of cannabis use disorder among people who use cannabis is relatively high. As the business of cannabis—both legal and illicit—and its use continue to grow, mental health and medical professionals must be prepared to address the effects of cannabis on the mind and body. Equipping providers with the relevant information is the intention of The Other Side of Cannabis. Relying on the insights of experts from around the world, this volume examines, among many other topics: • The frequency of use and deleterious effects of cannabis on adolescents, adults, and older adults• The link between cannabis and psychosis• The relationship between cannabis and posttraumatic stress disorder and anxiety disorders• The effects of cannabis on fertility—both male and female• The mechanisms and efficacy of cannabinoids on treating chronic pain Extensively referenced, this guide is rich in figures and tables for ease of reference. Key points at the end of each chapter aid in the retention and recall of the most important information. Readers will come away with a comprehensive understanding of the detrimental impact of cannabis use and be better positioned to educate patients, the public, and policymakers.
Doctors by nature : how ants, apes, and other animals heal themselves
\"What happens when animals get sick? Do they rely exclusively on their bodies own defense systems to protect them, or are there other behaviors they can use to heal themselves? Humans have been using plants, fungi, and other natural mechanisms to treat ailments and disease for millennia--why not animals too? It turns out they do! In 1987, primatologist Michael Huffman noticed an ill chimpanzee collecting shoots of a plant called Vernonia amygdalina, which humans in the area used to treat stomach upset and fever. The ill chimpanzee removed the plant's outer bark and sucked on the soft inner branches. Within 24 hours, she appeared to have largely recovered. Although there have been stories about animals medicating themselves, and traditional healers have looked to animals to help develop treatments for years, Huffman's observations are widely considered the first official scientific evidence of an animal actively medicating itself to treat disease. Since then, scientists have found conclusive evidence for medication in all manner of species--including bees, ants and butterflies, as well as monkeys, birds, apes, and elephants. Self-medication behaviors (for which scientists have developed a rigorous field definition) range from prophylactic consumption of anti-parasitic berries by monkeys and therapeutic use of alkaloids by woolly bear caterpillars, to blue jays' use of ant-produced formic acid as bug-repellent. In Animal Doctors, Professor of Biology and science communicator Jaap de Roode will provide an overview of the scientific study of animal self-medication, drawing on both the scientific literature and first-person interviews with key contributors to the field to ask how animals use medication against the parasites and pathogens that ail them\"-- Provided by publisher.
The stickup kids
2012,2013,2019
Randol Contreras came of age in the South Bronx during the 1980s, a time when the community was devastated by cuts in social services, a rise in arson and abandonment, and the rise of crack-cocaine. For this riveting book, he returns to the South Bronx with a sociological eye and provides an unprecedented insider's look at the workings of a group of Dominican drug robbers. Known on the streets as \"Stickup Kids,\" these men raided and brutally tortured drug dealers storing large amounts of heroin, cocaine, marijuana, and cash. As a participant observer, Randol Contreras offers both a personal and theoretical account for the rise of the Stickup Kids and their violence. He mainly focuses on the lives of neighborhood friends, who went from being crack dealers to drug robbers once their lucrative crack market opportunities disappeared. The result is a stunning, vivid, on-the-ground ethnographic description of a drug robbery's violence, the drug market high life, the criminal life course, and the eventual pain and suffering experienced by the casualties of the Crack Era. Provocative and eye-opening, The Stickup Kids urges us to explore the ravages of the drug trade through weaving history, biography, social structure, and drug market forces. It offers a revelatory explanation for drug market violence by masterfully uncovering the hidden social forces that produce violent and self-destructive individuals. Part memoir, part penetrating analysis, this book is engaging, personal, deeply informed, and entirely absorbing.
Ten storey love song : a novel
\"Ten storey love song is a cutting but characteristally charismatic portrait of a deeply dysfunctional, creative, and drug-sodden world, delivered with great beauty and abandon\"--Cover p. [4].
Discretionary Justice
2011,2020
Juvenile drug courts are on the rise in the United States, as a result of a favorable political climate and justice officials' endorsement of the therapeutic jurisprudence movement--the concept of combining therapeutic care with correctional discipline. The goal is to divert nonviolent youth drug offenders into addiction treatment instead of long-term incarceration. Discretionary Justice overviews the system, taking readers behind the scenes of the juvenile drug court. Based on fifteen months of ethnographic fieldwork and interviews at a California court, Leslie Paik explores the staff's decision-making practices in assessing the youths' cases, concentrating on the way accountability and noncompliance are assessed. Using the concept of \"workability,\" Paik demonstrates how compliance, and what is seen by staff as \"noncompliance,\" are the constructed results of staff decisions, fluctuating budgets, and sometimes questionable drug test results.
While these courts largely focus on holding youths responsible for their actions, this book underscores the social factors that shape how staff members view progress in the court. Paik also emphasizes the perspectives of children and parents. Given the growing emphasis on individual responsibility in other settings, such as schools and public welfare agencies, Paik's findings are relevant outside the juvenile justice system.