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PARTNER TRIAL II

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https://www.readbyqxmd.com/read/29097108/everolimus-plus-letrozole-for-treatment-of-patients-with-hr-her2-advanced-breast-cancer-progressing-on-endocrine-therapy-an-open-label-phase-ii-trial
#1
Tamar Safra, Bella Kaufman, Luna Kadouri, Noa Efrat Ben-Baruch, Larisa Ryvo, Bella Nisenbaum, Ella Evron, Rinat Yerushalmi
PURPOSE: In the Breast cancer trials of OraL EveROlimus-2 (BOLERO-2) trial, everolimus plus exemestane improved progression-free survival (PFS) in patients with hormone receptor-positive (HR(+)), human epidermal growth factor receptor 2-negative (HER2(-)) advanced breast cancer (ABC) recurring or progressing on/after prior endocrine therapy (ET), suggesting that dual blockade using targeted therapy and ET was an effective treatment option. Here, we investigated the clinical benefit of combining everolimus with different endocrine partner, letrozole, in a similar patient population...
September 19, 2017: Clinical Breast Cancer
https://www.readbyqxmd.com/read/28973091/association-of-paravalvular-regurgitation-with-1-year-outcomes-after-transcatheter-aortic-valve-replacement-with-the-sapien-3-valve
#2
Philippe Pibarot, Rebecca T Hahn, Neil J Weissman, Marie Arsenault, Jonathan Beaudoin, Mathieu Bernier, Abdellaziz Dahou, Omar K Khalique, Federico M Asch, Oumhani Toubal, Jonathon Leipsic, Philipp Blanke, Feifan Zhang, Rupa Parvataneni, Maria Alu, Howard Herrmann, Raj Makkar, Michael Mack, Richard Smalling, Martin Leon, Vinod H Thourani, Susheel Kodali
Importance: Moderate/severe and even mild paravalvular regurgitation (PVR) are associated with increased mortality following transcatheter aortic valve replacement (TAVR) with first and second generations of transcatheter valves. Objective: To examine the incidence, evolution, and effect on 1-year outcomes of PVR following TAVR with a third-generation balloon-expandable transcatheter heart valve. Design, Setting, and Participants: Prespecified analysis of PVR in the Placement of Aortic Transcatheter Valves (PARTNER) II SAPIEN 3 trial, conducted between October 1, 2013, and September 3, 2014...
November 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28898283/sustained-effectiveness-and-cost-effectiveness-of-the-healthy-activity-programme-a-brief-psychological-treatment-for-depression-delivered-by-lay-counsellors-in-primary-care-12-month-follow-up-of-a-randomised-controlled-trial
#3
RANDOMIZED CONTROLLED TRIAL
Benedict Weobong, Helen A Weiss, David McDaid, Daisy R Singla, Steven D Hollon, Abhijit Nadkarni, A-La Park, Bhargav Bhat, Basavraj Katti, Arpita Anand, Sona Dimidjian, Ricardo Araya, Michael King, Lakshmi Vijayakumar, G Terence Wilson, Richard Velleman, Betty R Kirkwood, Christopher G Fairburn, Vikram Patel
BACKGROUND: The Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes. METHODS AND FINDINGS: Primary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months...
September 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28874327/collagenase-clostridium-histolyticum-in-the-treatment-of-peyronie-s-disease-a-review-of-the-literature-and-a-new-modified-protocol
#4
REVIEW
Amr Abdel Raheem, Mark Johnson, Tarek Abdel-Raheem, Marco Capece, David Ralph
INTRODUCTION: Peyronie's disease (PD) is a common condition that results in penile deformity, which makes sexual intercourse difficult or impossible, and causes psychological, emotional, and relationship difficulties for the man affected and his partner. Collagenase Clostridium histolyticum (CCH; Xiapex, Xiaflex) is the first licensed non-surgical treatment option for PD. The safety and efficacy have been demonstrated in two large phase III randomized controlled trials (IMPRESS I and IMPRESS II)...
September 2, 2017: Sexual Medicine Reviews
https://www.readbyqxmd.com/read/28835533/a-phase-ii-clinical-study-to-assess-the-feasibility-of-self-and-partner-anal-examinations-to-detect-anal-canal-abnormalities-including-anal-cancer
#5
Alan G Nyitray, Joseph T Hicks, Lu-Yu Hwang, Sarah Baraniuk, Margaret White, Stefanos Millas, Nkechi Onwuka, Xiaotao Zhang, Eric L Brown, Michael W Ross, Elizabeth Y Chiao
OBJECTIVE: Anal cancer is a common cancer among men who have sex with men (MSM); however, there is no standard screening protocol for anal cancer. We conducted a phase II clinical trial to assess the feasibility of teaching MSM to recognise palpable masses in the anal canal which is a common sign of anal cancer in men. METHODS: A clinician skilled in performing digital anorectal examinations (DARE) used a pelvic manikin to train 200 MSM, aged 27-78 years, how to do a self-anal examination (SAE) for singles or a partner anal examination (PAE) for couples...
August 23, 2017: Sexually Transmitted Infections
https://www.readbyqxmd.com/read/28738857/investigating-interventions-to-increase-uptake-of-hiv-testing-and-linkage-into-care-or-prevention-for-male-partners-of-pregnant-women-in-antenatal-clinics-in-blantyre-malawi-study-protocol-for-a-cluster-randomised-trial
#6
Augustine T Choko, Katherine Fielding, Nigel Stallard, Hendramoorthy Maheswaran, Aurelia Lepine, Nicola Desmond, Moses K Kumwenda, Elizabeth L Corbett
BACKGROUND: Despite large-scale efforts to diagnose people living with HIV, 54% remain undiagnosed in sub-Saharan Africa. The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women. Here, we design a study to investigate the effect on uptake of HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention among male partners of pregnant women...
July 24, 2017: Trials
https://www.readbyqxmd.com/read/28734891/ct-defined-prosthesis-patient-mismatch-downgrades-frequency-and-severity-and%C3%A2-demonstrates-no-association-with-adverse-outcomes-after-tavr
#7
John Mooney, Stephanie L Sellers, Phillip Blanke, Philippe Pibarot, Rebecca T Hahn, Danny Dvir, Pamela S Douglas, Neil J Weissman, Susheel K Kodali, Vinod H Thourani, Hasan Jilaihawi, Omar Khalique, Craig R Smith, Shaw Hua Kueh, Mickael Ohana, Romi Grover, Christopher Naoum, Aaron Crowley, Wael A Jaber, Maria C Alu, Rupa Parvataneni, Michael Mack, John G Webb, Martin B Leon, Jonathon A Leipsic
OBJECTIVES: This study sought to determine if indexed effective orifice area (EOAi), using left ventricular outflow tract measured from computed tomography (EOAiCT), reclassified prosthesis-patient mismatch (PPM) compared with conventional echocardiogram-defined measurements (EOAiTTE). BACKGROUND: PPM does not predict mortality following transcatheter aortic valve replacement (TAVR). However, it is unknown if the EOAiCT of the left ventricular outflow tract improves risk stratification...
July 13, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28719225/association-between-social-support-and-self-care-behaviors-in-adults-with-chronic-obstructive-pulmonary-disease
#8
Zijing Chen, Vincent S Fan, Basia Belza, Kenneth Pike, Huong Q Nguyen
RATIONALE: Higher social support is associated with a better quality of life and functioning in adults with chronic obstructive pulmonary disease (COPD). OBJECTIVES: To determine the association between structural and functional social support and self-care behaviors in adults with COPD. METHODS: This was a longitudinal study using data from the CASCADE (COPD Activity: Serotonin Transporter, Cytokines, and Depression) study which was focused on depression and functioning in COPD...
July 18, 2017: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/28684004/tavr-vs-savr-rising-expectations-and-changing-indications-for-surgery-in-response-to-partner-ii
#9
COMPARATIVE STUDY
Cristiano Spadaccio, Francesco Nappi, Jean-Louis Sablayrolles, Fraser W H Sutherland
Despite the criticisms and concerns raised on the data published in the PARTNER II trial and related analyses, we are undeniably witnessing a revolution in the management of aortic valve disease, in which conventional full sternotomy surgical aortic valve replacement (SAVR), with all related complications and clinical burden, will soon become a nonviable option. Several of the findings described in the PARTNER II trial, although considerable as points of incongruence and study biases in comparison with SAVR, could be taken as lessons to found a new course in SAVR and redesign the respective roles of surgery and interventional procedures in aortic disease...
April 2017: Seminars in Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28647166/clinical-development-of-a-recombinant-ebola-vaccine-in-the-midst-of-an-unprecedented-epidemic
#10
Beth-Ann G Coller, Jeffrey Blue, Rituparna Das, Sheri Dubey, Lynn Finelli, Swati Gupta, Frans Helmond, Rebecca J Grant-Klein, Kenneth Liu, Jakub Simon, Sean Troth, Susan VanRheenen, Julie Waterbury, Ashley Wivel, Jayanthi Wolf, D Gray Heppner, Tracy Kemp, Rick Nichols, Thomas P Monath
The 2014-2016 Ebola outbreak caused over 28,000 cases and 11,000 deaths. Merck & Co. Inc., Kenilworth, NJ USA and NewLink Genetics are working with private and public partners to develop and license an Ebola vaccine that was evaluated extensively during the outbreak. The vaccine referred to as V920 is a recombinant vesicular stomatitis virus (rVSV) in which the VSV-G envelope glycoprotein (GP) is completely replaced by the Zaire ebolavirus GP (rVSVΔG-ZEBOV-GP). Eight Phase I and four Phase II/III clinical trials enrolling approximately 17,000 subjects were conducted in parallel to the outbreak to assess the safety, immunogenicity, and/or efficacy of V920...
June 21, 2017: Vaccine
https://www.readbyqxmd.com/read/28601506/effects-of-sex-education-and-kegel-exercises-on-the-sexual-function-of-postmenopausal-women-a-randomized-clinical-trial
#11
Soheila Nazarpour, Masoumeh Simbar, Fahimeh Ramezani Tehrani, Hamid Alavi Majd
BACKGROUND: The sex lives of women are strongly affected by menopause. Non-pharmacologic approaches to improving the sexual function of postmenopausal women might prove effective. AIM: To compare two methods of intervention (formal sex education and Kegel exercises) with routine postmenopausal care services in a randomized clinical trial. METHODS: A randomized clinical trial was conducted of 145 postmenopausal women residing in Chalus and Noshahr, Iran...
June 7, 2017: Journal of Sexual Medicine
https://www.readbyqxmd.com/read/28569053/pathology-of-balloon-expandable-transcatheter-aortic-valves
#12
Kazuyuki Yahagi, Elena Ladich, Robert Kutys, Hiroyoshi Mori, Lars G Svensson, Michael J Mack, Howard C Herrmann, Craig R Smith, Martin B Leon, Renu Virmani, Aloke V Finn
BACKGROUND: The Placement of AoRtic TraNscathetER Valves trials (PARTNER) showed favorable safety and efficacy versus medical or surgical therapy in inoperable, high, and intermediate surgical risk patients with severe aortic stenosis. However, the biological responses to transcatheter aortic valves have not been well characterized. OBJECTIVES: The aim of this study was to perform pathologic assessment of Edwards SAPIEN transcatheter aortic valves removed either at autopsy or surgically during the PARTNER I and II clinical trials...
June 1, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28484614/creating-beauty-creativity-compensates-for-low-physical-attractiveness-when-individuals-assess-the-attractiveness-of-social-and-romantic-partners
#13
Christopher D Watkins
Although creativity is attractive in a potential mate, it is unclear (i) whether the effects of creativity on attractiveness generalize to other social contexts and (ii) whether creativity has equivalent effects on men's and women's attractiveness. As social knowledge of creativity may either enhance or 'offset' the appeal of social partners who differ in physical attractiveness, three repeated measures experiments were conducted to directly address these issues. Here, participants rated a series of face-text pairs for attractiveness on trials that differed in one of four combinations of facial attractiveness (attractive and less attractive) and creativity (creative and less creative), rating story-tellers in two experiments (short interpretations of an identical painting) and creative ideas in a further experiment (alternative uses for an everyday object)...
April 2017: Royal Society Open Science
https://www.readbyqxmd.com/read/28480334/hpv-serostatus-pre-and-post-vaccination-in-a-randomized-phase-ii-preparedness-trial-among-young-western-cape-south-african-women-the-evri-trial
#14
Staci L Sudenga, B Nelson Torres, Matthys H Botha, Michele Zeier, Martha E Abrahamsen, Richard H Glashoff, Susan Engelbrecht, Maarten F Schim Van der Loeff, Louvina E Van der Laan, Siegfried Kipping, Douglas Taylor, Anna R Giuliano
BACKGROUND: HPV antibodies are a marker of past exposure to the virus. Our objective was to assess HPV serostatus pre- and post-vaccination among HIV-negative women. METHODS: Women aged 16-24 years old were randomized in a placebo controlled trial utilizing the 4-valent HPV (4vHPV) vaccine (NCT01489527, clinicaltrials.gov). Participants (n=389) received the 4vHPV vaccine or placebo following a three dose schedule. Sera were collected at Day 1 and Month 7 for assessment of HPV 6, 11, 16, and 18 neutralizing antibody levels using a multiplex competitive Luminex immunoassay (Merck) based on detecting the L1 capsid antigen for each HPV type...
June 2017: Papillomavirus Research
https://www.readbyqxmd.com/read/28473128/transcatheter-aortic-valve-implantation-within-degenerated-aortic-surgical-bioprostheses-partner-2-valve-in-valve-registry
#15
MULTICENTER STUDY
John G Webb, Michael J Mack, Jonathon M White, Danny Dvir, Philipp Blanke, Howard C Herrmann, Jonathon Leipsic, Susheel K Kodali, Raj Makkar, D Craig Miller, Philippe Pibarot, Augusto Pichard, Lowell F Satler, Lars Svensson, Maria C Alu, Rakesh M Suri, Martin B Leon
BACKGROUND: Early experience with transcatheter aortic valve replacement (TAVR) within failed bioprosthetic surgical aortic valves has shown that valve-in-valve (VIV) TAVR is a feasible therapeutic option with acceptable acute procedural results. OBJECTIVES: The authors examined 30-day and 1-year outcomes in a large cohort of high-risk patients undergoing VIV TAVR. METHODS: Patients with symptomatic degeneration of surgical aortic bioprostheses at high risk (≥50% major morbidity or mortality) for reoperative surgery were prospectively enrolled in the multicenter PARTNER (Placement of Aortic Transcatheter Valves) 2 VIV trial and continued access registries...
May 9, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28427598/computed-tomography-based-oversizing-degrees-and-incidence-of-paravalvular-regurgitation-of-a-new-generation-transcatheter-heart-valve
#16
MULTICENTER STUDY
Philipp Blanke, Philippe Pibarot, Rebecca Hahn, Neil Weissman, Susheel Kodali, Vinod Thourani, Rupa Parvataneni, Danny Dvir, Christopher Naoum, Bjarne L Nørgaard, Pamela Douglas, Wael Jaber, Omar K Khalique, Hasan Jilaihawi, Michael Mack, Craig Smith, Martin Leon, John Webb, Jonathon Leipsic
OBJECTIVES: The aim of the study was to investigate the influence of the extent of computed tomography (CT)-based area and perimeter oversizing on the incidence and severity of paravalvular aortic regurgitation (PAR) for the Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) device, using CT data and echocardiographic outcome data of the PARTNER II (Placement of AoRTic TraNscathetER Valves Trial II) SAPIEN 3 intermediate-risk cohort. BACKGROUND: Transcatheter heart valve (THV) sizing algorithms are device specific, requiring refinements for new valve designs...
April 24, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28353535/increasing-voluntary-medical-male-circumcision-vmmc-uptake-among-adult-men-in-tanzania-a-randomised-controlled-trial
#17
Mwita Wambura, Hally Mahler, Jonathan M Grund, Natasha Larke, Gerry Mshana, Evodius Kuringe, Marya Plotkin, Gissenge Lija, Maende Makohka, Fern Terris-Prestholt, Richard J Hayes, John Changalucha, Helen A Weiss
OBJECTIVE: We evaluated a demand creation intervention to increase voluntary medical male circumcision (VMMC) uptake among men aged 20-34 years in Tanzania, to maximise short-term impact on HIV incidence. METHODS: A cluster-randomised controlled trial stratified by region was conducted in 20 outreach sites in Njombe and Tabora regions. The sites were randomised 1:1 to receive either a demand-creation intervention package in addition to standard VMMC outreach, or standard VMMC outreach alone...
March 28, 2017: AIDS
https://www.readbyqxmd.com/read/28351928/ribociclib-lee011-mechanism-of-action-and-clinical-impact-of-this-selective-cyclin-dependent-kinase-4-6-inhibitor-in-various-solid-tumors
#18
REVIEW
Debu Tripathy, Aditya Bardia, William R Sellers
The cyclin D-cyclin-dependent kinase (CDK) 4/6-p16-retinoblastoma (Rb) pathway is commonly disrupted in cancer, leading to abnormal cell proliferation. Therapeutics targeting this pathway have demonstrated antitumor effects in preclinical and clinical studies. Ribociclib is a selective, orally bioavailable inhibitor of CDK4 and CDK6, which received FDA approval in March 2017 and is set to enter the treatment landscape alongside other CDK4/6 inhibitors, including palbociclib and abemaciclib. Here, we describe the mechanism of action of ribociclib and review preclinical and clinical data from phase I, II, and III trials of ribociclib across different tumor types, within the context of other selective CDK4/6 inhibitors...
March 28, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28315268/sigma-1-receptor-antagonists-a-new-class-of-neuromodulatory-analgesics
#19
REVIEW
Cristina Sánchez-Fernández, José Manuel Entrena, José Manuel Baeyens, Enrique José Cobos
The sigma-1 receptor is a unique ligand-operated chaperone present in key areas for pain control, in both the peripheral and central nervous system. Sigma-1 receptors interact with a variety of protein targets to modify their function. These targets include several G-protein-coupled receptors such as the μ-opioid receptor, and ion channels such as the N-methyl-D-aspartate receptor (NMDAR). Sigma-1 antagonists modify the chaperoning activity of sigma-1 receptor by increasing opioid signaling and decreasing NMDAR responses, consequently enhancing opioid antinociception and decreasing the sensory hypersensitivity that characterizes pathological pain conditions...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/28126440/activation-of-anti-oxidant-nrf2-signaling-by-substituted-trans-stilbenes
#20
Lorraine M Deck, Lisa J Whalen, Lucy A Hunsaker, Robert E Royer, David L Vander Jagt
Nrf2, which is a member of the cap'n'collar family of transcription factors, is a major regulator of phase II detoxification and anti-oxidant genes as well as anti-inflammatory and neuroprotective genes. The importance of inflammation and oxidative stress in many chronic diseases supports the concept that activation of anti-oxidant Nrf2 signaling may have therapeutic potential. A number of Nrf2 activators have entered into clinical trials. Nrf2 exists in the cytosol in complex with its binding partner Keap1, which is a thiol-rich redox-sensing protein...
February 15, 2017: Bioorganic & Medicinal Chemistry
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