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https://www.readbyqxmd.com/read/28226183/development-of-an-acceptable-and-feasible-self-management-group-for-children-young-people-and-families-living-with-type-1-diabetes
#1
R A Cai, R I G Holt, L Casdagli, R M Viner, R Thompson, K Barnard, D Christie
AIMS: This study developed an acceptable and feasible self-management intervention that addresses the self-identified needs of children and young people with Type 1 diabetes and their parents. METHODS: Phase 1 reviewed previous interventions and interviewed the clinical team, young people and families. Phase 2 ran three age-matched focus groups with 11 families of children aged 8-16 years. Feedback was used to modify the workshop. Phase 3 evaluated feasibility of delivery, as well as the effects on metabolic control, quality of life and fear of hypoglycaemia, measured at baseline and 1-3 months post intervention...
February 22, 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28225313/efficacy-and-safety-of-a-new-topical-testosterone-replacement-gel-therapy-for-the-treatment-of-male-hypogonadism
#2
Glenn Cunningham, Laurence Belkoff, Gerald Brock, Mitchell Efros, Marc Gittelman, Dario Carrara, Anders Neijber, Masakazu Ando, Jules Mitchel
OBJECTIVE: Testosterone replacement therapy is indicated for male hypogonadism. This study aimed to evaluate the efficacy and safety of Testosterone gel 2% (Tgel) over 90-days. METHODS: This phase 3, open-label, non-comparator study was conducted in adult hypogonadal men (two consecutive fasting serum testosterone values <300 ng/dL and >86% subjects with symptoms consistent with testosterone deficiency). Subjects applied Tgel 23 mg/day (single pump-actuation using hands-free cap applicator)...
February 22, 2017: Endocrine Practice
https://www.readbyqxmd.com/read/28222251/prognostic-methylation-markers-for-overall-survival-in-cytogenetically-normal-patients-with-acute-myeloid-leukemia-treated-on-swog-trials
#3
Xiaoyu Qu, Megan Othus, Jerry Davison, Yu Wu, Liying Yan, Soheil Meshinchi, Fabiana Ostronoff, Elihu H Estey, Jerry P Radich, Harry P Erba, Frederick R Appelbaum, Min Fang
BACKGROUND: Aberrant DNA methylation is known to occur in patients with acute myeloid leukemia (AML), whereas methylation signatures and prognostic markers have been proposed. The objective of the current study was to evaluate all CpG sites of the genome and identify prognostic methylation markers for overall survival in patients with AML with normal karyotype (AML-NK). METHODS: AML-NK samples from 7 SWOG trials were analyzed using a novel genome-wide approach called "CHARMcox" (comprehensive high-throughput array-based relative methylation analysis combined with the Cox proportional hazards model) controlling for known clinical covariates...
February 21, 2017: Cancer
https://www.readbyqxmd.com/read/28220631/treatment-of-bleeding-episodes-with-recombinant-factor-viii-fc-fusion-protein-in-a-long-study-subjects-with-severe-haemophilia-a
#4
A D Shapiro, J N Mahlangu, D Perry, J Pasi, D V Quon, P Chowdary, E Tsao, S Li, A Innes, G F Pierce, G A Allen
INTRODUCTION: The Phase 3 A-LONG study demonstrated the safety and efficacy of rFVIIIFc for the control and prevention of bleeding episodes in severe haemophilia A. AIM: To describe the treatment of bleeding episodes with rFVIIIFc in the A-LONG study. METHODS: A-LONG subjects (<1 IU dL(-1) endogenous FVIII) were treated with individualized prophylaxis (Arm 1), weekly prophylaxis (Arm 2) or episodic treatment (Arm 3). Information recorded for each bleeding episode included type, location and dose to treat the episode...
February 20, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28218410/pharmacokinetics-and-pharmacodynamics-of-tolvaptan-in-autosomal-dominant-polycystic-kidney-disease-phase-2-trials-for-dose-selection-in-the-pivotal-phase-3-trial
#5
Susan E Shoaf, Arlene B Chapman, Vicente E Torres, John Ouyang, Frank S Czerwiec
In the pivotal TEMPO 3:4 trial, the arginine vasopressin V2-receptor antagonist tolvaptan reduced the rate of kidney growth in patients with autosomal dominant polycystic kidney disease. Tolvaptan was initiated as daily morning/afternoon doses of 45/15 mg, and uptitrated weekly to 60/30 mg and 90/30 mg according to patient-reported tolerability. The current report describes 3 phase 2 trials in adult autosomal dominant polycystic kidney disease subjects that were the basis for the titrated split-dose regimen: a single ascending-dose trial (tolvaptan 15 to 120 mg; n = 11), a multiple split-dose trial (tolvaptan 15/15 mg, 30/0 mg, 30/15 mg, and 30/30 mg; n = 37), and an 8-week open-label safety and efficacy trial in 46 of the 48 subjects who participated in the prior 2 trials (tolvaptan 30/15 mg, 45/15 mg, 60/30 mg, and 90/30 mg)...
February 20, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28217871/secukinumab-in-active-rheumatoid-arthritis-a-randomized-double-blind-placebo-and-active-comparator-controlled-phase-3-study
#6
Francisco J Blanco, Rüdiger Möricke, Eva Dokoupilova, Christine Codding, Jeffrey Neal, Mats Andersson, Susanne Rohrer, Hanno Richards
OBJECTIVE: To evaluate the efficacy and safety of secukinumab in patients with active rheumatoid arthritis (RA) who had an inadequate response or intolerance to tumor necrosis factor inhibitors (TNF-inhibitors). METHODS: In this phase 3 study, 551 patients were randomized (1:1:1:1) to receive intravenous secukinumab 10 mg/kg (baseline, weeks 2, 4) followed by subcutaneous secukinumab 150 mg or 75 mg every 4 weeks or abatacept or placebo at the same dosing schedule...
February 19, 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/28217466/secukinumab-efficacy-and-safety-in-indian-patients-with-moderate-to-severe-plaque-psoriasis-sub-analysis-from-fixture-a-randomized-placebo-controlled-phase-3-study
#7
Ramesh M Bhat, B Leelavathy, Sacchidanand S Aradhya, Maragondanahalli G Gopal, D V S Pratap, Mir Mubashir, Putta Srinivas, Sushil Y Pande, Amit S Thavkar
TITLE: Secukinumab efficacy and safety in Indian patients with moderate-to-severe plaque psoriasis: sub-analysis from FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), a randomized, placebo-controlled, phase 3 study. BACKGROUND: Evidence has suggested Interleukin (IL)-17A to be an important effector cytokine in the pathogenesis of psoriasis. Here, we report results for an Indian sub-population from a multinational study FIXTURE, designed to assess the safety, tolerability, and long-term efficacy of fully human anti-IL-17A monoclonal antibody secukinumab in patients with moderate-to-severe plaque psoriasis...
January 2017: Indian Dermatology Online Journal
https://www.readbyqxmd.com/read/28217259/phase-3-trial-of-first-generation-protease-inhibitor-therapy-for-hepatitis-c-virus-human-immunodeficiency-virus-coinfection
#8
Kenneth E Sherman, Minhee Kang, Richard Sterling, Triin Umbleja, Kristen Marks, Jennifer J Kiser, Beverly Alston-Smith, Wayne Greaves, Adeel A Butt, The Actg Birth Study Team
AIM: To evaluate efficacy/safety of hepatitis C virus (HCV) protease inhibitor boceprevir with pegylated interferon (PEG-IFN) alfa and weight-based ribavirin (RBV) in a phase 3 trial. METHODS: A prospective, multicenter, phase 3, open-label, single-arm study of PEG-IFN alfa, weight-based RBV, and boceprevir, with a PEG-IFN/RBV lead-in phase was performed. The HCV/human immunodeficiency virus coinfected study population included treatment naïve (TN) and treatment experienced (TE) patients...
February 8, 2017: World Journal of Hepatology
https://www.readbyqxmd.com/read/28215937/long-term-treatment-with-evolocumab-added-to-conventional-drug-therapy-with-or-without-apheresis-in-patients-with-homozygous-familial-hypercholesterolaemia-an-interim-subset-analysis-of-the-open-label-taussig-study
#9
Frederick J Raal, G Kees Hovingh, Dirk Blom, Raul D Santos, Mariko Harada-Shiba, Eric Bruckert, Patrick Couture, Handrean Soran, Gerald F Watts, Christopher Kurtz, Narimon Honarpour, Lihua Tang, Sree Kasichayanula, Scott M Wasserman, Evan A Stein
BACKGROUND: Homozygous familial hypercholesterolaemia is a genetic disorder characterised by substantially raised LDL cholesterol, reduced LDL receptor function, xanthomas, and cardiovascular disease before age 20 years. Conventional therapy is with statins, ezetimibe, and apheresis. We aimed to assess the long-term safety and efficacy of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab in a subset of patients with homozygous familial hypercholesterolaemia enrolled in an open-label, non-randomised phase 3 trial...
February 16, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28215665/11-years-follow-up-of-trastuzumab-after-adjuvant-chemotherapy-in-her2-positive-early-breast-cancer-final-analysis-of-the-herceptin-adjuvant-hera-trial
#10
David Cameron, Martine J Piccart-Gebhart, Richard D Gelber, Marion Procter, Aron Goldhirsch, Evandro de Azambuja, Gilberto Castro, Michael Untch, Ian Smith, Luca Gianni, Jose Baselga, Nedal Al-Sakaff, Sabine Lauer, Eleanor McFadden, Brian Leyland-Jones, Richard Bell, Mitch Dowsett, Christian Jackisch
BACKGROUND: Clinical trials have shown that trastuzumab, a recombinant monoclonal antibody against HER2 receptor, significantly improves overall survival and disease-free survival in women with HER2-positive early breast cancer, but long-term follow-up data are needed. We report the results of comparing observation with two durations of trastuzumab treatment at a median follow-up of 11 years, for patients enrolled in the HERA (HERceptin Adjuvant) trial. METHODS: HERA (BIG 1-01) is an international, multicentre, open-label, phase 3 randomised trial of 5102 women with HER2-positive early breast cancer, who were enrolled from hospitals in 39 countries between Dec 7, 2001, and June 20, 2005...
February 16, 2017: Lancet
https://www.readbyqxmd.com/read/28215615/factors-associated-with-persistent-increase-in-level-of-alanine-aminotransferase-in-patients-with-chronic-hepatitis-b-receiving-oral-antiviral-therapy
#11
Ira M Jacobson, Mary K Washington, Maria Buti, Alexander Thompson, Nezam Afdhal, Robert Flisiak, Ulus Salih Akarca, Konstantin G Tchernev, John F Flaherty, Raul Aguilar Schall, Robert P Myers, G Mani Subramanian, John G McHutchison, Zobair Younossi, Patrick Marcellin, Keyur Patel
BACKGROUND & AIM: Despite complete suppression of viral DNA with antiviral agents, in some patients with chronic hepatitis B (CHB), serum levels of alanine aminotransferase (ALT) do not normalize. We investigated factors associated with persistent increases in level of ALT in patients with CHB given long-term tenofovir disoproxil fumarate. METHODS: We analyzed data from 471 hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients with CHB participating in 2 phase 3 trials...
February 12, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28215389/dissemination-and-implementation-science-training-needs-insights-from-practitioners-and-researchers
#12
Rachel G Tabak, Margaret M Padek, Jon F Kerner, Kurt C Stange, Enola K Proctor, Maureen J Dobbins, Graham A Colditz, David A Chambers, Ross C Brownson
INTRODUCTION: Dissemination and implementation research training has great potential to improve the impact and reach of health-related research; however, research training needs from the end user perspective are unknown. This paper identifies and prioritizes dissemination and implementation research training needs. METHODS: A diverse sample of researchers, practitioners, and policymakers was invited to participate in Concept Mapping in 2014-2015. Phase 1 (Brainstorming) gathered participants' responses to the prompt: To improve the impact of research evidence in practice and policy settings, a skill in which researchers need more training is… The resulting statement list was edited and included subsequent phases...
March 2017: American Journal of Preventive Medicine
https://www.readbyqxmd.com/read/28215362/efficacy-and-safety-of-sirukumab-in-patients-with-active-rheumatoid-arthritis-refractory-to-anti-tnf-therapy-sirround-t-a-randomised-double-blind-placebo-controlled-parallel-group-multinational-phase-3-study
#13
Daniel Aletaha, Clifton O Bingham, Yoshiya Tanaka, Prasheen Agarwal, Regina Kurrasch, Paul P Tak, Sharon Popik
BACKGROUND: Sirukumab, a human monoclonal antibody that selectively binds to the interleukin-6 cytokine with high affinity, is under development for the treatment of rheumatoid arthritis and other diseases. We aimed to assess the efficacy and safety of sirukumab for rheumatoid arthritis in a phase 3 study (SIRROUND-T). METHODS: We did a randomised, double-blind, placebo-controlled, parallel-group, multicentre study at 183 hospitals and private rheumatology clinics in 20 countries (Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Taiwan, UK, and USA)...
February 15, 2017: Lancet
https://www.readbyqxmd.com/read/28214977/braf-mutated-colorectal-cancer-what-is-the-optimal-strategy-for-treatment
#14
REVIEW
Romain Cohen, Pascale Cervera, Magali Svrcek, Anna Pellat, Chantal Dreyer, Aimery de Gramont, Thierry André
The BRAF activating mutation, harbored by approximately 10% of colorectal cancers (CRC), confers dramatic prognosis to advanced diseases. In early-stage setting, the identification of the BRAF mutation does not impact the therapeutic decision. Yet, the BRAF mutation could be considered as a stratification factor in adjuvant trials, because of its prognostic impact after relapse. Moreover, both BRAF mutation and mismatch repair (MMR) statuses should be determined in all CRC to help identify sporadic tumors versus Lynch syndrome-related tumors...
February 2017: Current Treatment Options in Oncology
https://www.readbyqxmd.com/read/28213957/a-bosentan-pharmacokinetic-study-to-investigate-dosing-regimens-in-paediatric-patients-with-pulmonary-arterial-hypertension-future-3
#15
R M F Berger, M Gehin, M Beghetti, D Ivy, A Kusic-Pajic, P Cornelisse, S Grill, D Bonnet
AIM: To investigate whether increasing bosentan dosing frequency from 2 mg/kg twice daily (b.i.d.) to 2 mg/kg three times daily (t.i.d.) in children with pulmonary arterial hypertension (PAH) (from ≥3 months to <12 years of age) would increase exposure. METHODS: An open-label, prospective, randomised, multicentre, multiple-dose, Phase 3 study was conducted. Patients (n = 64) were randomised 1:1 to receive oral doses of bosentan of 2 mg/kg b.i...
February 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28213943/a-phase-2-safety-study-of-accelerated-elotuzumab-infusion-over-less-than-1-hour-in-combination-with-lenalidomide-and-dexamethasone-in-patients-with-multiple-myeloma
#16
James Berenson, Robert Manges, Suprith Badarinath, Alan Cartmell, Kristi McIntyre, Roger Lyons, Wael Harb, Hesham Mohamed, Ali Nourbakhsh, Robert Rifkin
Elotuzumab, an immunostimulatory SLAMF7-targeting monoclonal antibody, induces myeloma cell death with minimal effects on normal tissue. In a previous phase 3 study in patients with relapsed/refractory multiple myeloma (RRMM), elotuzumab (10 mg/kg, ∼3-hour infusion), combined with lenalidomide and dexamethasone, demonstrated durable efficacy and acceptable safety; 10% (33/321) of patients had infusion reactions (IRs; Grade 1/2: 29; Grade 3: 4). This phase 2 study (NCT02159365) investigated an accelerated infusion schedule in 70 patients with newly diagnosed multiple myeloma or RRMM...
February 18, 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28213862/apremilast-a-review-in-psoriasis-and-psoriatic-arthritis
#17
Gillian M Keating
Apremilast (Otezla(®)) is an orally administered, small molecule inhibitor of phosphodiesterase 4 (PDE4). Apremilast 30 mg twice daily reduced the severity of moderate to severe plaque psoriasis in the phase 3 ESTEEM trials, as well as improving difficult-to-treat nail, scalp and palmoplantar psoriasis. Most patient-reported outcomes, including pruritus and the total Dermatology Life Quality Index, also improved to a significantly greater extent with apremilast than with placebo, with significant improvements in pruritus and skin discomfort/pain visual analogue scale scores seen as early as week 2 with apremilast...
February 18, 2017: Drugs
https://www.readbyqxmd.com/read/28212292/azacitidine-for-front-line-therapy-of-patients-with-aml-reproducible-efficacy-established-by-direct-comparison-of-international-phase-3-trial-data-with-registry-data-from-the-austrian-azacitidine-registry-of-the-agmt-study-group
#18
Lisa Pleyer, Hartmut Döhner, Hervé Dombret, John F Seymour, Andre C Schuh, C L Beach, Arlene S Swern, Sonja Burgstaller, Reinhard Stauder, Michael Girschikofsky, Heinz Sill, Konstantin Schlick, Josef Thaler, Britta Halter, Sigrid Machherndl Spandl, Armin Zebisch, Angelika Pichler, Michael Pfeilstöcker, Eva M Autzinger, Alois Lang, Klaus Geissler, Daniela Voskova, Wolfgang R Sperr, Sabine Hojas, Inga M Rogulj, Johannes Andel, Richard Greil
We recently published a clinically-meaningful improvement in median overall survival (OS) for patients with acute myeloid leukaemia (AML), >30% bone marrow (BM) blasts and white blood cell (WBC) count ≤15 G/L, treated with front-line azacitidine versus conventional care regimens within a phase 3 clinical trial (AZA-AML-001; NCT01074047; registered: February 2010). As results obtained in clinical trials are facing increased pressure to be confirmed by real-world data, we aimed to test whether data obtained in the AZA-AML-001 trial accurately represent observations made in routine clinical practice by analysing additional AML patients treated with azacitidine front-line within the Austrian Azacitidine Registry (AAR; NCT01595295; registered: May 2012) and directly comparing patient-level data of both cohorts...
February 15, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28212264/correlated-emg-oscillations-between-antagonists-during-cocontraction-in-men
#19
Yasuhide Yoshitake, Hiroaki Kanehisa, Minoru Shinohara
PURPOSE: The purpose of this study was to determine the modulation of common low-frequency oscillations in pools of motor units across antagonistic muscles because of the difference in the activation level of pools of spinal motor neurons and the presence of neuromuscular fatigue during intended cocontraction. METHODS: Ten healthy young men (21.8 ± 1.5 yr) performed intended steady cocontractions of elbow flexors and extensors at maximal and a submaximal (10% of maximal EMG) effort...
March 2017: Medicine and Science in Sports and Exercise
https://www.readbyqxmd.com/read/28212060/pembrolizumab-as-second-line-therapy-for-advanced-urothelial-carcinoma
#20
Joaquim Bellmunt, Ronald de Wit, David J Vaughn, Yves Fradet, Jae-Lyun Lee, Lawrence Fong, Nicholas J Vogelzang, Miguel A Climent, Daniel P Petrylak, Toni K Choueiri, Andrea Necchi, Winald Gerritsen, Howard Gurney, David I Quinn, Stéphane Culine, Cora N Sternberg, Yabing Mai, Christian H Poehlein, Rodolfo F Perini, Dean F Bajorin
Background Patients with advanced urothelial carcinoma that progresses after platinum-based chemotherapy have a poor prognosis and limited treatment options. Methods In this open-label, international, phase 3 trial, we randomly assigned 542 patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy to receive pembrolizumab (a highly selective, humanized monoclonal IgG4κ isotype antibody against programmed death 1 [PD-1]) at a dose of 200 mg every 3 weeks or the investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine...
February 17, 2017: New England Journal of Medicine
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