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MASS Trial

Lingling He, Xiaoli Liu, Lijia Wang, Zhiyun Yang
The findings regarding the effects of thiazolidinediones (TZDs) in nonalcoholic steatohepatitis (NASH) patients have been inconsistent, and the assessment of different clinical variables for evaluating the effects of TZDs confound a direct comparison of the results of different randomized clinical trials (RCTs), especially with regard to lifestyle changes. In this paper, we performed a meta-analysis of randomized controlled trials to clarify the effects of TZD treatment with and without lifestyle changes on histological markers of NASH and clinical variables related to insulin resistance (IR), hyperlipidemia, and obesity...
October 2016: Medicine (Baltimore)
Homero Rivas, Ignacio Robles, Francisco Riquelme, Marcelo Vivanco, Julio Jiménez, Boris Marinkovic, Mario Uribe
OBJECTIVE: To evaluate a new magnetic surgical system during reduced-port laparoscopic cholecystectomy in a prospective, multicenter clinical trial. BACKGROUND: Laparoscopic instrumentation coupled by magnetic fields may enhance surgeon performance by allowing for shaft-less retraction and mobilization. The movements can be performed under direct visualization, generating different angles of traction and reducing the number of trocars to perform the procedure. This may reduce well-known associated complications of trocars, including incisional pain, scarring, infection, bowel, and vascular injuries, among others...
October 17, 2016: Annals of Surgery
Adam J Toth, Laurence R Harris, John Zettel, Leah R Bent
Visuo-vestibular recalibration, in which visual information is used to alter the interpretation of vestibular signals, has been shown to influence both oculomotor control and navigation. Here we investigate whether vision can recalibrate the vestibular feedback used during the re-establishment of equilibrium following a perturbation. The perturbation recovery responses of nine participants were examined following exposure to a period of 11 s of galvanic vestibular stimulation (GVS). During GVS in VISION trials, occlusion spectacles provided 4 s of visual information that enabled participants to correct for the GVS-induced tilt and associate this asymmetric vestibular signal with a visually provided 'upright'...
October 17, 2016: Experimental Brain Research. Experimentelle Hirnforschung. Expérimentation Cérébrale
Wanhee Suk, JiEun Kim, Do-Yeon Kim, Hyunjung Lim, Ryowon Choue
Recent trial results suggest that the consumption of a low glycemic index (GI) diet is beneficial in the prevention of high blood glucose levels. Identifying active hypoglycemic substances in ordinary foods could be a significant benefit to the management of blood glucose. It has been hypothesized that noodles with Bombyx mori powder are a low GI food. We evaluated GI and changes in postprandial glucose levels following consumption of those noodles and compared them with those following consumption of plain wheat flour noodles (control) and glucose (reference) in healthy subjects...
September 2016: Preventive Nutrition and Food Science
Canan Ziylan, Annemien Haveman-Nies, Stefanie Kremer, Lisette C P G M de Groot
OBJECTIVES: Sufficient protein intake can decrease undernutrition risk among community-dwelling older adults. This study aimed to increase community-dwelling older adults' daily protein intake with acceptable and applicable protein-enriched bread and readymade meals at home. DESIGN: Double-blind randomized controlled trial of 2 weeks. SETTING: Senior residential center in the Netherlands. PARTICIPANTS: Forty-two community-dwelling elderly residents (≥65 years) participated, with a mean age of 74...
October 14, 2016: Journal of the American Medical Directors Association
Hao Yan, Wei Fang, Aiwu Lin, Liou Cao, Zhaohui Ni, Jiaqi Qian
BACKGROUND: Incident patients treated with continuous ambulatory peritoneal dialysis (CAPD) are often prescribed either 3 or 4 exchanges per day. However, the effects on residual kidney function and clinical outcomes of 3 versus 4 exchanges are not known. STUDY DESIGN: Prospective, randomized, controlled, open-label study. SETTING & PARTICIPANTS: Incident CAPD patients aged 18 to 80 years with glomerular filtration rates (GFRs; mean of renal urea and creatinine clearance from a 24-hour urine collection) ≥ 2mL/min and urine volume ≥ 500mL/d...
October 14, 2016: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
Kawsar R Talaat, Ruth D Ellis, Janet Hurd, Autumn Hentrich, Erin Gabriel, Noreen A Hynes, Kelly M Rausch, Daming Zhu, Olga Muratova, Raul Herrera, Charles Anderson, David Jones, Joan Aebig, Sarah Brockley, Nicholas J MacDonald, Xiaowei Wang, Michael P Fay, Sara A Healy, Anna P Durbin, David L Narum, Yimin Wu, Patrick E Duffy
Transmission-blocking vaccines (TBVs) that target sexual stage parasite development could be an integral part of measures for malaria elimination. Pfs25 is a leading TBV candidate, and previous studies conducted in animals demonstrated an improvement of its functional immunogenicity after conjugation to EPA, a recombinant, detoxified ExoProtein A from Pseudomonas aeruginosa. In this report, we describe results of an open-label, dose-escalating Phase 1 trial to assess the safety and immunogenicity of Pfs25-EPA conjugates formulated with Alhydrogel®...
2016: PloS One
Jacobo Á Rubio-Arias, Elena Marín-Cascales, Domingo J Ramos-Campo, Alejandro Martínez, Linda H Chung, Pedro E Alcaraz
OBJECTIVE: The purpose of the present systematic review and meta-analysis was to evaluate published, randomized controlled trials that investigated the effects of whole-body vibration training (WBVT) on lean mass in postmenopausal women. METHODS: The following electronic databases were searched from September to October 2015: PubMed, Web of Science, and Cochrane. Two different authors tabulated, independently, the selected indices in identical predetermined forms...
October 3, 2016: Menopause: the Journal of the North American Menopause Society
Alex S Ribeiro, Brad J Schoenfeld, Steven J Fleck, Fábio L C Pina, Matheus A Nascimento, Edilson S Cyrino
The purpose of the present study was to investigate the effect of resistance training (RT) performed in a pyramid (PR) versus a traditional (TD) system on muscular strength, muscle mass, and hormonal responses in older women. Twenty-five older women (67.6 ± 5.1 years, 65.9 ± 11.1 kg, 154.7 ± 5.8 cm, and 27.5 ± 4.5 kg m) performed both a TD and PR system RT program in a balanced crossover design. The TD program consisted of 3 sets of 8-12 RM with a constant load for the 3 sets, whereas the PR system consisted of 3 sets of 12/10/8 RM with incrementally higher loads for each set...
September 23, 2016: Journal of Strength and Conditioning Research
Gareth T Jones, Elizabeth A Jones, Marcus J Beasley, Gary J Macfarlane
The generalisability of randomised controlled trials will be compromised if markers of treatment outcome also affect trial recruitment. In a large trial of chronic widespread pain (CWP), we aimed to determine the extent to which randomised participants represented eligible patients, and whether factors predicting randomisation also influenced trial outcome. Adults from eight UK general practices were surveyed to determine eligibility for a trial of two interventions (exercise, and cognitive behavioural therapy (CBT))...
September 29, 2016: Pain
Sarah Jones, William D-C Man, Wei Gao, Irene J Higginson, Andrew Wilcock, Matthew Maddocks
BACKGROUND: This review is an update of a previously published review in the Cochrane Database of Systematic Reviews Issue 1, 2013 on Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease.Patients with advanced progressive disease often experience muscle weakness, which can impact adversely on their ability to be independent and their quality of life. In those patients who are unable or unwilling to undertake whole-body exercise, neuromuscular electrical stimulation (NMES) may be an alternative treatment to enhance lower limb muscle strength...
October 17, 2016: Cochrane Database of Systematic Reviews
Nicholas D Spence, Amanda S Newton, Rachel A Keaschuk, Kathryn A Ambler, Mary M Jetha, Nicholas L Holt, Rhonda J Rosychuk, John C Spence, Arya M Sharma, Geoff D C Ball
INTRODUCTION: Attrition in pediatric weight management is a substantial problem. This study examined factors associated with short- and long-term attrition from a lifestyle and behavioral intervention for parents of children with overweight or obesity. METHOD: Fifty-two families with children ages 6 to 12 years old and body mass index at or above the 85th percentile participated in a randomized controlled trial focused on parents, comparing parent-based cognitive behavioral therapy with parent-based psychoeducation for pediatric weight management...
October 12, 2016: Journal of Pediatric Health Care
Hung-Jui Tan, Siwei Xiong, Aaron A Laviana, Ryan J Chuang, Eric Treat, Patrick C Walsh, Jim C Hu
INTRODUCTION: Postprostatectomy incontinence significantly impairs quality of life. Although bladder neck intussusception has been reported to accelerate urinary recovery after open radical retropubic prostatectomy, its adaption to robotic surgery has not been assessed. Accordingly, we describe our technique and compare outcomes between men treated with and without bladder neck intussusception during robot-assisted laparoscopic prostatectomy. MATERIALS AND METHODS: We performed a comparative trial of 48 men undergoing robot-assisted laparoscopic prostatectomy alternating between bladder neck intussusception (n = 24) and nonintussusception (n = 24)...
October 12, 2016: Urologic Oncology
Irene Fleur Kramer, Lex B Verdijk, Henrike M Hamer, Sjors Verlaan, Yvette C Luiking, Imre W K Kouw, Joan M Senden, Janneau van Kranenburg, Annemarie P Gijsen, Jörgen Bierau, Martijn Poeze, Luc J C van Loon
BACKGROUND: Studying the muscle protein synthetic response to food intake in elderly is important, as it aids the development of interventions to combat sarcopenia. Although sarcopenic elderly are the target group for many of these nutritional interventions, no studies have assessed basal or post-prandial muscle protein synthesis rates in this population. OBJECTIVE: To assess the basal and post-prandial muscle protein synthesis rates between healthy and sarcopenic older men...
September 29, 2016: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
Kms Kanhai, S C Goulooze, J Stevens, J L Hay, G Dent, A Verma, T Hankemeier, T de Boer, H Meijering, J C Chavez, A F Cohen, G J Groeneveld
Therapeutics promoting myelin synthesis may enhance recovery in demyelinating diseases, such as multiple sclerosis. However, no suitable method exists to quantify myelination. The turnover of galactosylceramide (myelin component) is indicative of myelination in mice, but its turnover has not been determined in humans. Here, six healthy subjects consumed 120 mL 70% D2 O daily for 70 days to label galactosylceramide. We then used mass spectrometry and compartmental modeling to quantify the turnover rate of galactosylceramide in cerebrospinal fluid...
October 15, 2016: Clinical and Translational Science
Mirella Youssef Tawfik
: This study aims to investigate the impact of a health belief model (HBM)-based educational intervention on knowledge, beliefs, self-reported practices, gestational and postpartum weight in women with gestational diabetes mellitus (GDM). SUBJECTS AND METHODS: A cluster randomized controlled trial was performed, with randomization at the level of Primary Health Care centers in three Egyptian cities. Eligible women with GDM were enrolled at 24 weeks pregnancy. The intervention group (n = 103) received health education intervention based on the HBM construct...
October 14, 2016: Journal of Community Health
Mats O Magnusson, Mahesh N Samtani, Elodie L Plan, E Niclas Jonsson, Stefaan Rossenu, An Vermeulen, Alberto Russu
OBJECTIVES: Our objective was to characterize the population pharmacokinetics of paliperidone after intramuscular administration of its long-acting 3-month formulation palmitate ester at various doses and at different injection sites (deltoid and gluteal muscles). METHODS: This retrospective analysis included pooled data from 651 subjects from one phase I study (single injection of the 3-month formulation) and one phase III study (multiple injections of both 1- and 3-month formulations)...
October 14, 2016: Clinical Pharmacokinetics
Tino W Sanchez, Guangyu Zhang, Jitian Li, Liping Dai, Saied Mirshahidi, Nathan R Wall, Clayton Yates, Colwick Wilson, Susanne Montgomery, Jian-Ying Zhang, Carlos A Casiano
African American (AA) men suffer from a disproportionately high incidence and mortality of prostate cancer (PCa) compared to other racial/ethnic groups. Despite these disparities, African American men are underrepresented in clinical trials and in studies on PCa biology and biomarker discovery. We used immunoseroproteomics to profile anti-tumor autoantibody responses in AA and European American (EA) men with PCa, and explored differences in these responses. This minimally invasive approach detects autoantibodies to tumor-associated antigens that could serve as clinical biomarkers and immunotherapeutic agents...
October 14, 2016: Molecular & Cellular Proteomics: MCP
Julio A Chirinos, Scott R Akers, Lien Trieu, Harry Ischiropoulos, Paschalis-Thomas Doulias, Ali Tariq, Izzah Vassim, Maheswara R Koppula, Amer Ahmed Syed, Haideliza Soto-Calderon, Raymond R Townsend, Thomas P Cappola, Kenneth B Margulies, Payman Zamani
BACKGROUND: Stable plasma nitric oxide (NO) metabolites (NOM), composed predominantly of nitrate and nitrite, are attractive biomarkers of NO bioavailability. NOM levels integrate the influence of NO-synthase-derived NO production/metabolism, dietary intake of inorganic nitrate/nitrite, and clearance of NOM. Furthermore, nitrate and nitrite, the most abundant NOM, can be reduced to NO via the nitrate-nitrite-NO pathway. METHODS AND RESULTS: We compared serum NOM among subjects without heart failure (n=126), subjects with heart failure and preserved ejection fraction (HFpEF; n=43), and subjects with heart failure and reduced ejection fraction (HFrEF; n=32)...
October 14, 2016: Journal of the American Heart Association
Sara Boucher, Olivia Edwards, Andrew Gray, Shyamala Nada-Raja, Jason Lillis, Tracy L Tylka, Caroline C Horwath
BACKGROUND: Middle-aged women are at risk of weight gain and associated comorbidities. Deliberate restriction of food intake (dieting) produces short-term weight loss but is largely unsuccessful for long-term weight management. Two promising approaches for the prevention of weight gain are intuitive eating (ie, eating in accordance with hunger and satiety signals) and the development of greater psychological flexibility (ie, the aim of acceptance and commitment therapy [ACT]). OBJECTIVES: This pilot study investigated the usage, acceptability, and feasibility of "Mind, Body, Food," a Web-based weight gain prevention intervention prototype that teaches intuitive eating and psychological flexibility skills...
October 14, 2016: JMIR Research Protocols
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