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Acting : the basics
\"Acting: The Basics 3rd Edition is a dynamic response to recent societal and entertainment industry changes, focusing on inclusion, diversity and equity, and the actor's trajectory from training to rehearsal to performance on stage and screen, with hands-on tools and global perspectives. The book offers vital ways of building a practical acting toolkit, through breath, body, voice, emotions, imagination and spirit. We begin with a socio-cultural look at actor as magician, storyteller, healer and social changer. Throughout, there are insights from Black, Indigenous, First Nations, South/East Asian, intercultural and feminist practitioners, together with methods focusing on disability and accessibility, intimacy directives, mindfulness and intersectionality. Key 'canonical' figures still feature (e.g., Stanislavsky, Meisner, Brecht and Suzuki) with re-visioned perspective. Scattered throughout are post-COVID insights, plus expanded sections on screen acting (including self-tapes) and Shakespeare. This book is useful for beginner or expert, as it's always helpful getting back to basics. Because the author is both an actor and an actor trainer, the tools are steeped in user-friendly application. At the same time, transferable skills (e.g., dynamic listening and empathy) are shown as relevant to everyone. With a glossary of terms and useful online suggestions (including blogs, videos and podcasts), this is ideal for anyone learn anew about the practice and history of acting, or to take their acting and teaching into new terrain\"-- Provided by publisher.
Book
Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin
In a phase 3a trial involving adults with type 2 diabetes who had not previously received insulin, glycemic control was better with once-weekly insulin icodec than with once-daily insulin glargine U100.
Journal Article
The method : how the twentieth century learned to act
\"From the co-author of The World Only Spins Forward comes the first cultural history of Method acting--an ebullient account of creative discovery and the birth of classic Hollywood. On stage and screen, we know a great performance when we see it. But how do actors draw from their bodies and minds to turn their selves into art? What is the craft of being an authentic fake? More than a century ago, amid tsarist Russia's crushing repression, one of the most talented actors ever, Konstantin Stanislavski, asked these very questions, reached deep into himself, and emerged with an answer. How his 'system' remade itself into the Method and forever transformed American theater and film is an unlikely saga that has never before been fully told. Now, critic and theater director Isaac Butler chronicles the history of the Method in a narrative that transports readers from Moscow to New York to Los Angeles, from The Seagull to A Streetcar Named Desire to Raging Bull. He traces how a cohort of American mavericks--including Stella Adler, Lee Strasberg, and the storied Group Theatre--refashioned Stanislavski's ideas for a Depression-plagued nation that had yet to find its place as an artistic powerhouse. Strasberg and Adler's tempestuous feud would, in turn, shape generations of actors who enabled Hollywood to become the global dream-factory it is today. Some of these performers the Method would uplift; others, it would destroy. Long after its midcentury heyday, the Method lives on as one of the most influential--and misunderstood--ideas in American culture. Studded with marquee names--from Marlon Brando, Marilyn Monroe, and Elia Kazan, to James Baldwin, Ellen Burstyn, and Dustin Hoffman--The Method is a spirited history of ideas and a must-read for any fan of Broadway or American film\"-- Provided by publisher.
BOOK
Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial
Insulin efsitora alfa (efsitora) is a once-weekly basal insulin. This phase 3 study aimed to assess the efficacy and safety of efsitora compared with insulin degludec (degludec) in adults with type 1 diabetes.
This randomised, 52-week, parallel-design, open-label, treat-to-target non-inferiority study conducted at 82 global health-care centres, randomly assigned (1:1) adults (ie, those aged ≥18 years) with type 1 diabetes glycated haemoglobin A1c (HbA1c) 7·0–10·0% (53·0–85·8 mmol/mol) to efsitora (n=343) or, degludec (n=349), both in combination with insulin lispro. The primary endpoint was the change in HbA1c from baseline to week-26 (non-inferiority margin=0·4%). The trial was registered at ClinicalTrials.gov (NCT05463744) and is completed.
Between Aug 12, 2022, and May 7, 2024, of 893 participants enrolled, 692 (77%) participants were randomly assigned to once-weekly efsitora or once-daily degludec, and 623 (90%) participants completed the study. Mean HbA1c decreased from 7·88% (62·66 mmol/mol) at baseline to 7·41% (57·5 mmol/mol) at week 26 with efsitora and from 7·94% (63·3 mmol/mol) at baseline to 7·36% (56·9 mmol/mol) at week 26 with degludec. Mean HbA1c change from baseline to week 26 was –0·51% with efsitora and –0·56% with degludec (estimated treatment difference 0·052%, 95% CI –0·077 to 0·181; p=0·43), confirming a non-inferiority margin of 0·4% for efsitora compared with degludec. Rates of combined level 2 (<54 mg/dL [3·0 mmol/L]) or level 3 severe hypoglycaemia were higher with efsitora compared with degludec (14·03 vs 11·59 events per patient year of exposure; estimated rate ratio 1·21, 95% CI 1·04 to 1·41; p=0·016) during weeks 0–52, with the highest rates during weeks 0–12. Severe hypoglycaemia incidence was higher with efsitora (35 [10%] of 343) versus degludec (11 [3%] of 349) during weeks 0–52. Overall incidence of treatment-emergent adverse events was similar across treatment groups. One death not related to the study treatment occurred in the degludec group.
In adults with type 1 diabetes, once-weekly efsitora showed non-inferior HbA1c reduction compared with daily insulin degludec. Higher rates of combined level 2 or level 3 hypoglycaemia and greater incidence of severe hypoglycaemia in participants treated with efsitora compared with participants treated with degludec might suggest the need for additional evaluation of efsitora dose initiation and optimisation in people with type 1 diabetes.
Eli Lilly and Company.
Journal Article
Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial
Once-weekly insulin efsitora alfa (efsitora) is in development for the treatment of people with diabetes. The aim of the current study was to assess the efficacy and safety of once-weekly efsitora compared with daily insulin degludec (degludec) in adults with type 2 diabetes using basal insulin.
This randomised, 78-week, phase 3, parallel-design, open-label, treat-to-target, non-inferiority study (QWINT-3) was conducted at 127 sites across nine countries. Adults (aged ≥18 years) with type 2 diabetes currently treated with basal insulin, up to three non-insulin glucose-lowering medications without prandial insulin, and glycated haemoglobin A1c (HbA1c) 6·5–10·0% (48–86 mmol/mol) were eligible. Participants were randomly assigned (2:1) to receive efsitora (n=655) or degludec (n=331). The primary endpoint was the change in least-squares mean HbA1c concentration from baseline to week 26, assessed in all randomly allocated participants who took at least one dose of study drug (excluding those who discontinued due to inadvertent enrolment), with a non-inferiority margin of 0·4% for efsitora versus degludec. The completed trial is registered at ClinicalTrials.gov (NCT05275400).
Between March 8, 2022, and May 15, 2024, 1229 participants were enrolled and 986 (80%) were randomly allocated: 655 to the efsitora group and 331 to the degludec group, all of whom received at least one dose of study treatment. 871 (88%) of those randomly allocated completed 78 weeks of treatment. The population comprised 431 (44%) female and 555 (56%) male patients, median age was 62·0 years (IQR 54·0–68·0), baseline BMI was 29·65 kg/m2 (IQR 26·32–34·12), and HbA1c concentration was 7·7% (7·1–8·4). The least-squares mean change from baseline to week 26 in HbA1c concentration was –0·81 percentage points (SE 0·03; –8·85 mmol/mol [0·33]) in the efsitora group and –0·72 percentage points (0·04; –7·88 mmol/mol [0·46]) in the degludec group (estimated treatment difference –0·09 percentage points [95% CI –0·19 to 0·01]), indicating non-inferiority of efsitora to degludec. Combined level 2 hypoglycaemia (glucose concentration <54 mg/dL [<3·0 mmol/L]) or level 3 (severe) hypoglycaemia events from baseline to week 78 occurred at a similar rate for efsitora (0·84 events per patient-year of exposure; 754 events in 268 [41%] participants) and degludec (0·74 per patient-year of exposure; 346 events in 123 [37%] participants; estimated rate ratio 1·14 [95% CI 0·83–1·56]; p=0·43). Serious adverse events occurred in 103 (16%; 7 [1%] related to treatment) efsitora-treated and 37 (11%; 1 [<1%] related to treatment) degludec-treated participants; the most frequent (at ∼1%) were primarily cardiovascular-related in both groups. Nine deaths (seven in the efsitora group and two in the degludec group) occurred during the trial, but none were related to study treatment.
Efsitora is a well tolerated and efficacious once-weekly alternative to daily basal insulin, with a reduced injection frequency, for the treatment of adults with type 2 diabetes.
Eli Lilly and Company.
Journal Article
Plasma Exposure to Insulin Glargine and Its Metabolites M1 and M2 After Subcutaneous Injection of Therapeutic and Supratherapeutic Doses of Glargine in Subjects With Type 1 Diabetes
In vivo, after subcutaneous injection, insulin glargine (21(A)-Gly-31(B)-Arg-32(B)-Arg-human insulin) is enzymatically processed into 21(A)-Gly-human insulin (metabolite 1 [M1]). 21(A)-Gly-des-30(B)-Thr-human insulin (metabolite 2 [M2]) is also found. In vitro, glargine exhibits slightly higher affinity, whereas M1 and M2 exhibit lower affinity for IGF-1 receptor, as well as mitogenic properties, versus human insulin. The aim of the study was to quantitate plasma concentrations of glargine, M1, and M2 after subcutaneous injection of glargine in male type 1 diabetic subjects.
Glargine, M1, and M2 were determined in blood samples obtained from 12, 11, and 11 type 1 diabetic subjects who received single subcutaneous doses of 0.3, 0.6, or 1.2 units · kg(-1) glargine in a euglycemic clamp study. Glargine, M1, and M2 were extracted using immunoaffinity columns and quantified by a specific liquid chromatography-tandem mass spectrometry assay. Lower limit of quantification was 0.2 ng · mL(-1) (33 pmol · L(-1)) per analyte.
Plasma M1 concentration increased with increasing dose; geometric mean (percent coefficient of variation) M1-area under the curve between time of dosing and 30 h after dosing (AUC(0-30h)) was 1,261 (66), 2,867 (35), and 4,693 (22) pmol · h · L(-1) at doses of 0.3, 0.6, and 1.2 units · kg(-1), respectively, and correlated with metabolic effect assessed as pharmacodynamics-AUC(0-30h) of the glucose infusion rate following glargine administration (r = 0.74; P < 0.01). Glargine and M2 were detectable in only one-third of subjects and at a few time points.
After subcutaneous injection of glargine in male subjects with type 1 diabetes, exposure to glargine is marginal, if any, even at supratherapeutic doses. Glargine is rapidly and nearly completely processed to M1 (21(A)-Gly-human insulin), which mediates the metabolic effect of injected glargine.
Journal Article
Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial
Intensive basal-bolus insulin therapy has been shown to improve glycaemic control and reduce the risk of long-term complications that are associated with type 1 diabetes mellitus. Insulin degludec is a new, ultra-longacting basal insulin. We therefore compared the efficacy and safety of insulin degludec and insulin glargine, both administered once daily with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes.
In an open-label, treat-to-target, non-inferiority trial, undertaken at 79 sites (hospitals and centres) in six countries, adults (aged ≥18 years) with type 1 diabetes (glycated haemoglobin [HbA1c] ≤10% [86 mmol/mol]), who had been treated with basal-bolus insulin for at least 1 year, were randomly assigned in a 3:1 ratio, with a computer-generated blocked allocation sequence, to insulin degludec or insulin glargine without stratification by use of a central interactive response system. The primary outcome was non-inferiority of degludec to glargine, assessed as a reduction in HbA1c after 52 weeks, with the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00982228.
Of 629 participants, 472 were randomly assigned to insulin degludec and 157 to insulin glargine; all were analysed in their respective treatment groups. At 1 year, HbA1c had fallen by 0·40% points (SE 0·03) and 0·39% points (0·07), respectively, with insulin degludec and insulin glargine (estimated treatment difference −0·01% points [95% CI −0·14 to 0·11]; p<0·0001 for non-inferiority testing) and 188 (40%) and 67 (43%) participants achieved a target HbA1c of less than 7% (<53 mmol/mol). Rates of overall confirmed hypoglycaemia (plasma glucose <3·1 mmol/L or severe) were similar in the insulin degludec and insulin glargine groups (42·54 vs 40·18 episodes per patient-year of exposure; estimated rate ratio [degludec to glargine] 1·07 [0·89 to 1·28]; p=0·48). The rate of nocturnal confirmed hypoglycaemia was 25% lower with degludec than with glargine (4·41 vs 5·86 episodes per patient-year of exposure; 0·75 [0·59 to 0·96]; p=0·021). Overall serious adverse event rates (14 vs 16 events per 100 patient-years of exposure) were similar for the insulin degludec and insulin glargine groups.
Insulin degludec might be a useful basal insulin for patients with type 1 diabetes because it provides effective glycaemic control while lowering the risk of nocturnal hypoglycaemia, which is a major limitation of insulin therapy.
Novo Nordisk.
Journal Article