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Francesco Schettini, Mario Giuliano, Sabino De Placido, Grazia Arpino
Triple-negative breast cancer (TNBC) accounts for ∼10-20% of breast cancers and is associated with relatively poor prognosis, earlier disease recurrence and higher number of visceral metastases. Despite an increasing understanding of the molecular heterogeneity of TNBC, clinical trials of targeted agents have thus far been disappointing; chemotherapy, in particular with anthracycline and taxanes, remains the backbone medical management for both early and metastatic TNBC. Nab-paclitaxel is a solvent-free, albumin-bound, nanoparticle formulation of paclitaxel and represents a novel formulation of an established, effective chemotherapeutic agent...
September 12, 2016: Cancer Treatment Reviews
Pamela A Shaw, William S Yancy, Lisa Wesby, Victoria Ulrich, Andrea B Troxel, David Huffman, Gary D Foster, Kevin Volpp
BACKGROUND: Obesity continues to be a serious public health challenge. Rates are increasing worldwide, with nearly 70% of the US adults overweight or obese, leading to increased clinical and economic burden. While successful approaches for achieving weight loss have been identified, techniques for long-term maintenance of initial weight loss have largely been unsuccessful. Financial incentive interventions have been shown in several settings to be successful in motivating participants to adopt healthy behaviors...
September 19, 2016: Clinical Trials: Journal of the Society for Clinical Trials
James S McCarthy, Thomas Rückle, Elhadj Djeriou, Cathy Cantalloube, Daniel Ter-Minassian, Mark Baker, Peter O'Rourke, Paul Griffin, Louise Marquart, Rob Hooft van Huijsduijnen, Jörg J Möhrle
BACKGROUND: Ferroquine (SSR97193) is a candidate anti-malarial currently undergoing clinical trials for malaria. To better understand its pharmacokinetic (PK) and pharmacodynamic (PD) parameters the compound was tested in the experimentally induced blood stage malaria infection model in volunteers. METHODS: Male and non-pregnant female aged 18-50 years were screened for this phase II, controlled, single-centre clinical trial. Subjects were inoculated with ~1800 viable Plasmodium falciparum 3D7A-infected human erythrocytes, and treated with a single-dose of 800 mg ferroquine...
2016: Malaria Journal
Naoko Takebe, Mansoor M Ahmed, Bhadrasain Vikram, Eric J Bernhard, James Zwiebel, C Norman Coleman, Charles A Kunos
A number of oncology phase II radiochemotherapy trials with promising results have been conducted late in the overall experimental therapeutic agent development process. Accelerated development and approval of experimental therapeutic agents have stimulated further interest in much earlier radiation-agent studies to increase the likelihood of success in phase III trials. To sustain this interest, more forward-thinking preclinical radiobiology experimental designs are needed to improve discovery of promising radiochemotherapy plus agent combinations for clinical trial testing...
October 2016: Seminars in Radiation Oncology
Agnihotram V Ramanakumar, Paulo Naud, Cecilia M Roteli-Martins, Newton S de Carvalho, Paola C de Borba, Julio C Teixeira, Mark Blatter, Anna-Barbara Moscicki, Diane M Harper, Barbara Romanowski, Stephen K Tyring, Brian Ramjattan, Anne Schuind, Gary Dubin, Eduardo L Franco
OBJECTIVES: Persistence of human papillomaviruses (HPVs) is necessary for cervical carcinogenesis. We evaluated incidence and duration of type-specific HPV infections and the influence of age and number of sexual partners. METHODS: Data were obtained from 553 women (15-25 years), who were seronegative and DNA-negative for high-risk HPV (HR-HPV) types and were enrolled in the placebo arm of a randomised trial of the HPV-16/18 vaccine (NCT00689741/NCT00120848). They were followed for 6...
2016: BMJ Open
Liliana E Pezzin, Purushottam Laud, Joan Neuner, Tina W F Yen, Ann B Nattinger
BACKGROUND: Challenged by public opinion, peers and the Congressional Budget Office, medical specialty societies have begun to develop "Top Five" lists of expensive procedures that do not provide meaningful benefit to at least some categories of patients for whom they are commonly ordered. The extent to which these lists have influenced the behavior of physicians or patients, however, remains unknown. METHODS: We partner with a statewide consortium of health systems to examine the effectiveness of two interventions: (i) "basic" public reporting and (ii) an "enhanced" intervention, augmenting public reporting with a smart phone-based application that gives providers just-in-time information, decision-making tools, and personalized patient education materials to support reductions in the use of eight breast cancer interventions targeted by Choosing Wisely® or oncology society guidelines...
September 2016: Contemporary Clinical Trials
Tonya L Prescott, Gregory Phillips Ii, L Zachary DuBois, Sheana S Bull, Brian Mustanski, Michele L Ybarra
BACKGROUND: Using social networking websites to recruit research participants is increasingly documented in the literature, although few studies have leveraged these sites to reach those younger than 18 years. OBJECTIVE: To discuss the development and refinement of a recruitment protocol to reach and engage adolescent gay, bisexual, and other teenaged men who have sex with men (AGBM). Participants were recruited for development and evaluation activities related to Guy2Guy, a text messaging-based human immunodeficiency virus infection prevention program...
2016: Journal of Medical Internet Research
Marco Ruella, Carl H June
Genetic redirection of T lymphocytes allows us to unleash these potent cellular immune effectors against cancer. Chimeric antigen receptor (CAR) T cells are the best-in-class example that genetic engineering of T cells can lead to deep and durable responses, as has been shown in several clinical trials for CD19+ B cell malignancies. As a consequence, in the last few years, several academic institutions and commercial partners have started developing anti-CD19 CAR T cell products. Although most of these T cell products are highly effective in vivo, basic differences among them can generate different performance characteristics and thereby impact their long-term clinical outcome...
October 2016: Current Hematologic Malignancy Reports
Tara S Beattie, Shajy Isac, Parinita Bhattacharjee, Prakash Javalkar, Calum Davey, T Raghavendra, Sapna Nair, Satyanarayana Ramanaik, D L Kavitha, James F Blanchard, Charlotte Watts, Martine Collumbien, Stephen Moses, Lori Heise
BACKGROUND: Female sex workers (FSWs) are at increased risk of HIV and STIs compared to women in the general population, and frequently experience violence in their working and domestic lives from a variety of perpetrators, which can enhance this risk. While progress has been made in addressing violence by police and clients, little work has been done to understand and prevent violence by intimate partners (IPs) among FSW populations. METHODS: Samvedana Plus is a multi-level intervention programme that works with FSWs, their IPs, the sex worker community, and the general population, and aims to reduce violence and increase consistent condom use within these 'intimate' relationships...
2016: BMC Public Health
Javier Castrodeza, Ignacio J Amat-Santos, Myriam Blanco, Carlos Cortes, Javier Tobar, Irene Martin-Morquecho, Javier López, Salvatore Di Stefano, Paol Rojas, Luis H Varela-Falcon, Itziar Gomez, Jose A San Roman
BACKGROUND: Recently, the use of transcatheter aortic valve implantation (TAVI) in intermediate-low risk patients has been evaluated in the PARTNER II randomized trial. However, in the last years, this therapy has been employed in this scenario with underreported results, as compared to surgical aortic valve replacement (SAVR). METHODS: We enrolled 362 consecutive patients with severe symptomatic aortic stenosis and intermediate-low surgical risk (logEuroSCORE < 20%), treated in our center with TAVI (103 patients) or single SAVR (259 patients) between 2009 and 2014...
July 21, 2016: Cardiology Journal
Nanette Santoro, Esther Eisenberg, J C Trussell, LaTasha B Craig, Clarisa Gracia, Hao Huang, Ruben Alvero, Peter Casson, Gregory Christman, Christos Coutifaris, Michael Diamond, Susan Jin, Richard S Legro, Randal D Robinson, William D Schlaff, Heping Zhang
STUDY QUESTION: Does fertility-related quality of life (FertiQOL) differ by infertility diagnosis between women with polycystic ovary syndrome (PCOS) and their partners, compared with couples with unexplained infertility (UI)? SUMMARY ANSWER: Women with PCOS report lower QOL than those with UI, whereas males with UI report lower QOL than males with PCOS partners. WHAT IS KNOWN ALREADY: The fertility-specific QOL survey, FertiQOL, has been used to examine fertility-related QOL in a number of worldwide cohorts...
October 2016: Human Reproduction
Marc-Alain Widdowson, Stephanie J Schrag, Rosalind J Carter, Wendy Carr, Jennifer Legardy-Williams, Laura Gibson, Durodami R Lisk, Mohamed I Jalloh, Donald A Bash-Taqi, Samuel A Sheku Kargbo, Ayesha Idriss, Gibrilla F Deen, James B W Russell, Wendi McDonald, Alison P Albert, Michelle Basket, Amy Callis, Victoria M Carter, Kelli R Clifton Ogunsanya, Julianne Gee, Robert Pinner, Barbara E Mahon, Susan T Goldstein, Jane F Seward, Mohamed Samai, Anne Schuchat
In October 2014, the College of Medicine and Allied Health Sciences of the University of Sierra Leone, the Sierra Leone Ministry of Health and Sanitation, and CDC joined the global effort to accelerate assessment and availability of candidate Ebola vaccines and began planning for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). STRIVE was an individually randomized controlled phase II/III trial to evaluate efficacy, immunogenicity, and safety of the recombinant vesicular stomatitis virus Ebola vaccine (rVSV-ZEBOV)...
2016: MMWR Supplements
Benjamin Kasenda, Erik von Elm, John J You, Anette Blümle, Yuki Tomonaga, Ramon Saccilotto, Alain Amstutz, Theresa Bengough, Joerg J Meerpohl, Mihaela Stegert, Kelechi K Olu, Kari A O Tikkinen, Ignacio Neumann, Alonso Carrasco-Labra, Markus Faulhaber, Sohail M Mulla, Dominik Mertz, Elie A Akl, Dirk Bassler, Jason W Busse, Ignacio Ferreira-González, Francois Lamontagne, Alain Nordmann, Viktoria Gloy, Heike Raatz, Lorenzo Moja, Shanil Ebrahim, Stefan Schandelmaier, Xin Sun, Per O Vandvik, Bradley C Johnston, Martin A Walter, Bernard Burnand, Matthias Schwenkglenks, Lars G Hemkens, Heiner C Bucher, Gordon H Guyatt, Matthias Briel
BACKGROUND: Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. METHODS AND FINDINGS: We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003...
June 2016: PLoS Medicine
Ana Maria Buller, Melissa Hidrobo, Amber Peterman, Lori Heise
BACKGROUND: Intimate partner violence (IPV) is highly prevalent and has detrimental effects on the physical and mental health of women across the world. Despite emerging evidence on the impacts of cash transfers on intimate partner violence, the pathways through which reductions in violence occur remain under-explored. A randomised controlled trial of a cash and in-kind food transfer programme on the northern border of Ecuador showed that transfers reduced physical or sexual violence by 30 %...
2016: BMC Public Health
Lorna O'Doherty, Ann Taket, Jodie Valpied, Kelsey Hegarty
BACKGROUND: Interventions in health settings for intimate partner violence (IPV) are being increasingly recognised as part of a response to addressing this global public health problem. However, interventions targeting this sensitive social phenomenon are complex and highly susceptible to context. This study aimed to elucidate factors involved in women's uptake of a counselling intervention delivered by family doctors in the weave primary care trial (Victoria, Australia). METHODS: We analysed associations between women's and doctors' baseline characteristics and uptake of the intervention...
July 2016: Social Science & Medicine
Henry C Y Ho, Moses Mui, Alice Wan, Yin-Lam Ng, Sunita M Stewart, Carol Yew, Tai Hing Lam, Sophia S Chan
Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong...
2016: Frontiers in Psychology
Stephanie Du Four, Sarah K Maenhout, Daphné Benteyn, Brenda De Keersmaecker, Johnny Duerinck, Kris Thielemans, Bart Neyns, Joeri L Aerts
BACKGROUND: Recurrent glioblastoma is associated with a poor overall survival. Antiangiogenic therapy results in a high tumor response rate but has limited impact on survival. Immunotherapy has emerged as an efficient treatment modality for some cancers, and preclinical evidence indicates that anti-VEGF(R) therapy can counterbalance the immunosuppressive tumor microenvironment. METHODS: We collected peripheral blood mononuclear cells (PBMC) of patients with recurrent glioblastoma treated in a randomized phase II clinical trial comparing the effect of axitinib with axitinib plus lomustine and analyzed the immunophenotype of PBMC, the production of cytokines and expression of inhibitory molecules by circulating T cells...
June 2016: Cancer Immunology, Immunotherapy: CII
Jeannette Milgrom, Brian G Danaher, Alan W Gemmill, Charlene Holt, Christopher J Holt, John R Seeley, Milagra S Tyler, Jessica Ross, Jennifer Ericksen
BACKGROUND: There are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed. OBJECTIVE: In a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression...
2016: Journal of Medical Internet Research
S Yücel, H Ince, G D'Ancona, S Kische, A Öner
Transcatheter aortic valve implantation (TAVI) is an established and approved procedure with an increasing implantation rate, whilst the number of surgical aortic valve replacements (SAVR) remained unchanged (AQUA data). This demonstrates that more patients who were unsuitable for SAVR were treated with TAVI. First randomized trials have shown a significant survival benefit for TAVI compared to conservative therapy (PARTNER B) and non-inferiority to SAVR in high-risk patients (PARTNER A). The US pivotal trials demonstrated even a significant survival benefit in TAVI patients compared to SAVR...
March 2016: Herz
Martina Bocchetta, Anna Mega, Livia Bernardi, Emilio Di Maria, Luisa Benussi, Giuliano Binetti, Barbara Borroni, Rosanna Colao, Giuseppe Di Fede, Silvia Fostinelli, Daniela Galimberti, Massimo Gennarelli, Roberta Ghidoni, Irene Piaceri, Michela Pievani, Corinna Porteri, Veronica Redaelli, Giacomina Rossi, Silvia Suardi, Claudio Babiloni, Elio Scarpini, Fabrizio Tagliavini, Alessandro Padovani, Benedetta Nacmias, Sandro Sorbi, Giovanni B Frisoni, Amalia C Bruni
BACKGROUND: Genetic testing of familial Alzheimer's disease (AD) and frontotemporal lobar degeneration (FTLD) is attracting interest thanks to innovative primary prevention clinical trials and increased request for information by at-risk individuals. However, ethical, social, and psychological implications are paramount and genetic testing must be supported by structured genetic counseling. In Italy, practice parameters and guidelines for genetic counseling in dementia are not available...
2016: Journal of Alzheimer's Disease: JAD
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