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Patricia Healy, Sandra Galvin, Paula R Williamson, Shaun Treweek, Caroline Whiting, Beccy Maeso, Christopher Bray, Peter Brocklehurst, Mary Clarke Moloney, Abdel Douiri, Carrol Gamble, Heidi R Gardner, Derick Mitchell, Derek Stewart, Joan Jordan, Martin O'Donnell, Mike Clarke, Sue H Pavitt, Eleanor Woodford Guegan, Amanda Blatch-Jones, Valerie Smith, Hannah Reay, Declan Devane
BACKGROUND: Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy study aimed to identify and prioritise important unanswered trial recruitment questions for research. The PRioRiTy study - Priority Setting Partnership (PSP) included members of the public approached to take part in a randomised trial or who have represented participants on randomised trial steering committees, health professionals and research staff with experience of recruiting to randomised trials, people who have designed, conducted, analysed or reported on randomised trials and people with experience of randomised trials methodology...
March 1, 2018: Trials
Dan Clutterbuck, David Asboe, Tristan Barber, Carol Emerson, Nigel Field, Stuart Gibson, Gwenda Hughes, Rachael Jones, Martin Murchie, Achyuta V Nori, Michael Rayment, Ann Sullivan
This guideline is intended for use in UK Genitourinary medicine clinics and sexual health services but is likely to be of relevance in all sexual health settings, including general practice and Contraception and Sexual Health (CASH) services, where men who have sex with men (MSM) seek sexual health care or where addressing the sexual health needs of MSM may have public health benefits. For the purposes of this document, MSM includes all gay, bisexual and all other males who have sex with other males and both cis and trans men...
January 1, 2018: International Journal of STD & AIDS
David J Ralph, Ian Eardley, Jorg Taubel, Paul Terrill, Tim Holland
BACKGROUND: Current treatments for erectile dysfunction (ED) have some limitations. AIM: This study evaluated the efficacy and tolerability of MED2005, a 0.2% glyceryl trinitrate topical gel, formulated into an enhanced absorption topical delivery system (DermaSys), administered on demand, in the treatment of ED. METHODS: This randomized, double-blinded, placebo-controlled, phase II crossover trial involved 232 men with ED (231 treated, 230 assessed for efficacy) and their partners...
December 29, 2017: Journal of Sexual Medicine
Molly Szerlip, Sarah Gualano, Elizabeth Holper, John J Squiers, Jonathon M White, Darshan Doshi, Mathew R Williams, Rebecca T Hahn, John G Webb, Lars G Svensson, Ajay J Kirtane, David J Cohen, Pamela S Douglas, Maria C Alu, Aaron Crowley, E Murat Tuzcu, Raj R Makkar, Howard C Herrmann, Vasilis Babaliaros, Vinod H Thourani, Martin B Leon, Susheel K Kodali, Michael J Mack
OBJECTIVES: The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown...
January 8, 2018: JACC. Cardiovascular Interventions
Daren K Heyland, Judy Davidson, Yoanna Skrobik, Amanda Roze des Ordons, Lauren J Van Scoy, Andrew G Day, Virginia Vandall-Walker, Andrea P Marshall
BACKGROUND: Over the last decade, health care delivery has shifted to partnering with patients and their families to improve health and quality of care, and to lower costs. Partnering with family members (FMs) of critically ill patients who lack capacity is particularly important for improving experiences and outcomes for both patients and FMs. How best to apply such partnering strategies, however, is yet unknown. The IMPACT trial will evaluate two interventions that enable partnerships with families of critically ill patients, each in a distinct content area, but similar in that they empower and support FMs...
January 4, 2018: Trials
Sarah T Stahl, James Emanuel, Steven M Albert, Mary Amanda Dew, Richard Schulz, Gregg Robbins-Welty, Charles F Reynolds
Introduction: Experiencing the death of a spouse during late life is associated with an increased risk of developing debilitating mental health problems. Healthy lifestyle practices, such as regular exercise, healthy eating, and good sleep hygiene are promising strategies to influence the mental health and associated physical symptoms of late-life spousal bereavement. Objective: This paper describes the design and rationale of an intervention development study addressing selective and indicated prevention of depression, anxiety, and/or complicated grief disorder(s) among adults 60 years and older who are grieving the recent loss (within 8 months) of a spouse or partner...
December 2017: Contemporary Clinical Trials Communications
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
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
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
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)...
October 2017: Sexual Medicine Reviews
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
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
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
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
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
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 (rVSVĪ”G-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
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
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
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
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, 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
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