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Randomised trial

H Lindman, M Andersson, J Ahlgren, E Balslev, A Sverrisdottir, S B Holmberg, N O Bengtsson, E H Jacobsen, A B Jensen, J Hansen, M K Tuxen, L Malmberg, K Villman, H Anderson, B Ejlertsen, J Bergh, C Blomqvist
STUDY AIM: Retrospective studies have demonstrated a worse outcome in breast cancer patients not developing leukopenia during adjuvant chemotherapy. The SBG 2000-1 is the first randomised trial designed to compare individually dosed chemotherapy without G-CSF support based on grade of toxicity to standard-dosed chemotherapy based on body surface area (BSA). METHODS: Patients with early breast cancer were included and received the first cycle of standard FEC (fluorouracil 600 mg/m2 , epirubicin 60 mg/m2 , cyclophosphamide 600 mg/m2 )...
March 13, 2018: European Journal of Cancer
Charalampos S Siristatidis, Eleni Sertedaki, Dennis Vaidakis, Christos Varounis, Marialena Trivella
BACKGROUND: In order to overcome the low effectiveness of assisted reproductive technologies (ART) and the high incidence of multiple births, metabolomics is proposed as a non-invasive method to assess oocyte quality, embryo viability, and endometrial receptivity, and facilitate a targeted subfertility treatment. OBJECTIVES: To evaluate the effectiveness and safety of metabolomic assessment of oocyte quality, embryo viability, and endometrial receptivity for improving live birth or ongoing pregnancy rates in women undergoing ART, compared to conventional methods of assessment...
March 16, 2018: Cochrane Database of Systematic Reviews
Peter Clifton, Jennifer Keogh
The meta-analysis of plant sterol supplement studies suggests an 8% lowering of low density lipoprotein (LDL) cholesterol for 2 to 2.5 g/day of plant sterols. Cereal foods have been rarely tested, and one study showed a lower LDL lowering of 5.4% with 1.6 g of plant sterol in breakfast cereal. We aimed to test a breakfast wheat biscuit with 2 g of plant sterols in a single serve of two wholegrain wheat breakfast cereal biscuits. Fifty volunteers with a total cholesterol of >5.5 mmol/L were recruited for a randomised crossover study with two 4-week periods with no washout, of which 45 successfully completed the study...
March 16, 2018: Foods (Basel, Switzerland)
Kumari M Rathnayake, Michelle Weech, Kim G Jackson, Julie A Lovegrove
CVD are the leading cause of death in women globally, with ageing associated with progressive endothelial dysfunction and increased CVD risk. Natural menopause is characterised by raised non-fasting TAG concentrations and impairment of vascular function compared with premenopausal women. However, the mechanisms underlying the increased CVD risk after women have transitioned through the menopause are unclear. Dietary fat is an important modifiable risk factor relating to both postprandial lipaemia and vascular reactivity...
March 16, 2018: Nutrition Research Reviews
Neil E O'Connell, Louise Marston, Sally Spencer, Lorraine H DeSouza, Benedict M Wand
BACKGROUND: This is an updated version of the original Cochrane Review published in 2010, Issue 9, and last updated in 2014, Issue 4. Non-invasive brain stimulation techniques aim to induce an electrical stimulation of the brain in an attempt to reduce chronic pain by directly altering brain activity. They include repetitive transcranial magnetic stimulation (rTMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), transcranial random noise stimulation (tRNS) and reduced impedance non-invasive cortical electrostimulation (RINCE)...
March 16, 2018: Cochrane Database of Systematic Reviews
Anna M Leddy, Deanna Kerrigan, Caitlin E Kennedy, Jessie Mbwambo, Samuel Likindikoki, Carol R Underwood
Female sex workers experience high rates of gender-based violence and HIV. Alcohol has been shown to facilitate women's risk of both gender-based violence and HIV; however, little research has explored how aspects of the sex work environment shape this risk. Drawing on structuration theory, this study explored how social conduct is patterned across time and space within the sex work environment to influence alcohol consumption, gender-based violence and HIV risk among female sex workers. Qualitative in-depth interviews were conducted with 24 female sex workers enrolled in an ongoing community randomised controlled trial of a combination HIV prevention intervention in Iringa, Tanzania...
March 16, 2018: Culture, Health & Sexuality
Maciej Lesiak, Sylwia Zawada-Iwańczyk, Magdalena Łanocha, Aneta Klotzka, Michał Lesiak
Bioresorbable scaffolds (BRS) have been introduced to clinical practice to avoid some limitations associated with the presence of permanent metal prostheses in coronary arteries. Due to elimination of the natural vasomotion of the vessel and flow disturbance, stents impair endothelial function, increasing the risk of adverse events such as late and very late thrombosis or accelerated neoatherosclerosis. Additionally, the presence of metallic stents hinders non-invasive imaging of coronaries and may exclude the possibility of bypass graft anastomosis within the stented segment...
March 15, 2018: Minerva Cardioangiologica
Ruchita Dixit, Sowmya Nettem, Simerjit S Madan, Htoo Htoo Kyaw Soe, Adinegara Bl Abas, Leah D Vance, Patrick J Stover
BACKGROUND: Sickle cell disease (SCD) is a group of disorders that affects haemoglobin, which causes distorted sickle- or crescent-shaped red blood cells. It is characterized by anaemia, increased susceptibility to infections and episodes of pain. The disease is acquired by inheriting abnormal genes from both parents, the combination giving rise to different forms of the disease. Due to increased erythropoiesis in people with SCD, it is hypothesized that they are at an increased risk for folate deficiency...
March 16, 2018: Cochrane Database of Systematic Reviews
Lesley Uttley, Iñigo Bermejo, Shijie Ren, Marrissa Martyn-St James, Ruth Wong, David L Scott, Adam Young, Matt Stevenson
As part of its Single Technology Appraisal process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (Pfizer) of tofacitinib (TOF; Xeljanz® ) to submit evidence of the drug's clinical and cost-effectiveness in the treatment of rheumatoid arthritis (RA) after the failure of conventional disease-modifying antirheumatic drugs (cDMARDs). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
March 15, 2018: PharmacoEconomics
Stephen Honeybul, David Anthony Morrison, Kwok M Ho, Christopher R P Lind, Elizabeth Geelhoed
OBJECTIVE: To compare the long-term outcomes of patients who had been randomly allocated to receive primary titanium cranioplasty or autologous bone graft following decompressive craniectomy. METHODS: Sixty-four patients had been previously enrolled and randomised to receive either their own bone graft or a primary titanium cranioplasty. Functional and cosmetic outcomes had previously been assessed at 1-year following the cranioplasty procedure. Hospital records and the Picture Archiving communication system were reviewed to determine how many patients had cranioplasty failure or associated complications such as seizures beyond 1 year-with a minimum of 24-month follow-up...
March 15, 2018: Acta Neurochirurgica
Jane K O'Hara, Caroline Reynolds, Sally Moore, Gerry Armitage, Laura Sheard, Claire Marsh, Ian Watt, John Wright, Rebecca Lawton
BACKGROUND: Patient safety measurement remains a global challenge. Patients are an important but neglected source of learning; however, little is known about what patients can add to our understanding of safety. We sought to understand the incidence and nature of patient-reported safety concerns in hospital. METHODS: Feedback about the experience of safety within hospital was gathered from 2471 inpatients as part of a multicentre, waitlist cluster randomised controlled trial of an intervention, undertaken within 33 wards across three English NHS Trusts, between May 2013 and September 2014...
March 15, 2018: BMJ Quality & Safety
Przemyslaw Rys, Agnieszka H Ludwig-Słomczyńska, Katarzyna Cyganek, Maciej T Malecki
BACKGROUND: Randomised controlled trials (RCTs) have shown an advantage of continuous subcutaneous insulin infusion (CSII) over multiple daily injections (MDI) in the general type 1 diabetes mellitus (T1DM) population. RCT data on T1DM management in pregnancy remain limited. OBJECTIVE: We performed a systematic review of both RCTs and non-RCTs evaluating CSII versus MDI in T1DM-complicated pregnancy. STUDY DESIGN: Electronic databases were searched for studies comparing CSII with MDI in T1DM-complicated pregnancy...
March 15, 2018: European Journal of Endocrinology
Urho M Kujala
There are discrepant findings between (A) observational follow-ups and (B) interventional studies that investigate possible causal association between high physical activity and low mortality. Participation in vigorous physical activity at a specific time-point is an indicator of good fitness and health, and is associated with a reduced risk of death. However, neither randomised controlled trials nor experimental animal studies have provided conclusive evidence to show that physical activity started during adulthood extends lifespan...
March 15, 2018: British Journal of Sports Medicine
Raju Kapoor, Pei-Ran Ho, Nolan Campbell, Ih Chang, Aaron Deykin, Fiona Forrestal, Nisha Lucas, Bei Yu, Douglas L Arnold, Mark S Freedman, Myla D Goldman, Hans-Peter Hartung, Eva Kubala Havrdová, Douglas Jeffery, Aaron Miller, Finn Sellebjerg, Diego Cadavid, Dan Mikol, Deborah Steiner
BACKGROUND: Although several disease-modifying treatments are available for relapsing multiple sclerosis, treatment effects have been more modest in progressive multiple sclerosis and have been observed particularly in actively relapsing subgroups or those with lesion activity on imaging. We sought to assess whether natalizumab slows disease progression in secondary progressive multiple sclerosis, independent of relapses. METHODS: ASCEND was a phase 3, randomised, double-blind, placebo-controlled trial (part 1) with an optional 2 year open-label extension (part 2)...
March 12, 2018: Lancet Neurology
Eleonora Scorletti, Christopher D Byrne
For many years it has been known that high doses of long chain omega-3 fatty acids are beneficial in the treatment of hypertriglyceridaemia. Over the last three decades, there has also been a wealth of in vitro and in vivo data that has accumulated to suggest that long chain omega-3 fatty acid treatment might be beneficial to decrease liver triacylglycerol. Several biological mechanisms have been identified that support this hypothesis; notably, it has been shown that long chain omega-3 fatty acids have a beneficial effect: a) on bioactive metabolites involved in inflammatory pathways, and b) on alteration of nuclear transcription factor activities such as peroxisome proliferator-activated receptors (PPARs), sterol regulatory element-binding protein 1c (SREBP-1c) and carbohydrate-responsive element-binding protein (ChREBP), involved in inflammatory pathways and liver lipid metabolism...
March 12, 2018: Molecular Aspects of Medicine
Daina L Sturnieks, Sin Lin Yak, Mayna Ratanapongleka, Stephen R Lord, Jasmine C Menant
Fatigue is a common complaint in older people. Laboratory-induced muscle fatigue has been found to affect physical functions in older populations but these protocols are rigorous and are unlikely to accurately reflect daily activities. This study used an ecological approach to determine the effects of a busy day on self-reported fatigue and fall-related measures of physical and cognitive function in older people. Fifty community-dwelling adult volunteers, aged 60-88 (mean 73) years participated in this randomised crossover trial...
March 12, 2018: Experimental Gerontology
Joo-Yong Hahn, Young Bin Song, Ju-Hyeon Oh, Deok-Kyu Cho, Jin Bae Lee, Joon-Hyung Doh, Sang-Hyun Kim, Jin-Ok Jeong, Jang-Ho Bae, Byung-Ok Kim, Jang Hyun Cho, Il-Woo Suh, Doo-Il Kim, Hoon-Ki Park, Jong-Seon Park, Woong Gil Choi, Wang Soo Lee, Jihoon Kim, Ki Hong Choi, Taek Kyu Park, Joo Myung Lee, Jeong Hoon Yang, Jin-Ho Choi, Seung-Hyuk Choi, Hyeon-Cheol Gwon
BACKGROUND: Current guidelines recommend dual antiplatelet therapy (DAPT) of aspirin plus a P2Y12 inhibitor for at least 12 months after implantation of drug-eluting stents (DES) in patients with acute coronary syndrome. However, available data about the optimal duration of DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention are scant. We aimed to investigate whether a 6-month duration of DAPT would be non-inferior to the conventional 12-month or longer duration of DAPT in this population...
March 9, 2018: Lancet
Samuel Johnson, Sharmala Thuraisingam, John Furler, Jo-Anne Manski Nankervis
Insulin initiation is often delayed in primary care partly because of clinician concerns about the additional clinical work. This study describes health services usage (HSU) pre- and post-insulin initiation in people with type 2 diabetes and out-of-target glycaemic levels. Secondary analysis of participant data from the Stepping Up randomised controlled trial of a model of care for insulin initiation in general practice was undertaken. For 142 people who commenced insulin, HSU in the 6 months prior was compared to that in the 12 months following insulin initiation...
March 16, 2018: Australian Journal of Primary Health
Shazia Imran, Maryam Shan, Shazia Muazam
OBJECTIVE: To observe the effects of Shisha smoke on submucosal glands of trachea of mice; and compare it with tracheal glands of mice exposed to cigarette smoke. STUDY DESIGN: Randomised controlled trial. PLACE AND DURATION OF STUDY: Department of Anatomy, Islamic International Medical College, Rawalpindi, in collaboration with National Institute of Health (NIH), Islamabad from October 2013 till April 2014. METHODOLOGY: Sample comprised of 40 adult male mice of strain BALB/c...
March 2018: Journal of the College of Physicians and Surgeons—Pakistan: JCPSP
Faisal Junejo, Mohammad Irfan Akhtar, Mohammad Hamid, Syed Shabbir Ahmed, Fauzia Minai, Muneer Amanullah
OBJECTIVE: To compare the intravenous boluses and intravenous continuous infusion of tranexamic acid (TXA) to reduce postoperative bleeding in cyanotic congenital heart disease surgeries. STUDY DESIGN: Single-blinded randomised clinical trial. PLACE AND DURATION OF STUDY: Anaesthesia Department, The Aga Khan University Hospital, Karachi, from July 2016 to April 2017. METHODOLOGY: Sixty patients of cyanotic congenital heart disease, undergoing either palliative or corrective surgery involving cardiopulmonary bypass (CPB), were recruited...
March 2018: Journal of the College of Physicians and Surgeons—Pakistan: JCPSP
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