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Negative trials

Koichi Nagata, Shungo Endo, Tetsuro Honda, Takaaki Yasuda, Michiaki Hirayama, Sho Takahashi, Takashi Kato, Shoichi Horita, Ken Furuya, Kenji Kasai, Hiroshi Matsumoto, Yoshiki Kimura, Kenichi Utano, Hideharu Sugimoto, Hiroyuki Kato, Rieko Yamada, Junta Yamamichi, Takeshi Shimamoto, Yasuji Ryu, Osamu Matsui, Hitoshi Kondo, Ayako Doi, Taro Abe, Hiro-O Yamano, Ken Takeuchi, Hiroyuki Hanai, Yukihisa Saida, Katsuyuki Fukuda, Janne Näppi, Hiroyuki Yoshida
OBJECTIVES: The objective of this study was to assess prospectively the diagnostic accuracy of computer-assisted computed tomographic colonography (CTC) in the detection of polypoid (pedunculated or sessile) and nonpolypoid neoplasms and compare the accuracy between gastroenterologists and radiologists. METHODS: This nationwide multicenter prospective controlled trial recruited 1,257 participants with average or high risk of colorectal cancer at 14 Japanese institutions...
October 25, 2016: American Journal of Gastroenterology
Peter A Campochiaro, Kevin G Peters
Tie2 is a tyrosine kinase receptor located predominantly on vascular endothelial cells that plays a central role in vascular stability. Angiopoietin-1 (Angpt1), produced by perivascular cells, binds, clusters, and activates Tie2, leading to Tie2 autophosphorylation and downstream signaling. Activated Tie2 increases endothelial cell survival, adhesion, and cell junction integrity, thereby stabilizing the vasculature. Angiopoietin-2 (Angpt2) and vascular endothelial-protein tyrosine phosphatase (VE-PTP) are negative regulators increased by hypoxia; they inactivate Tie2, destabilizing the vasculature and increasing responsiveness to vascular endothelial growth factor (VEGF) and other inflammatory cytokines that stimulate vascular leakage and neovascularization...
December 2016: Current Diabetes Reports
August F Holtyn, Wendy Donlin Washington, Todd W Knealing, Conrad J Wong, Ken Kolodner, Kenneth Silverman
We sought to identify behavioral factors associated with response to an employment-based intervention, in which participants had to provide drug-free urine samples to gain access to paid employment. The present secondary analysis included data from a randomized clinical trial. The trial evaluated whether employment-based reinforcement could decrease cocaine use in community methadone patients. Participants (N=56) in the trial worked in a model workplace for 4 hr every weekday and earned about $10 per hr. After a 4-week baseline, participants were randomly assigned to an Abstinence & Work (n = 28) or Work Only (n = 28) condition and could work for an additional 26 weeks...
June 2016: Translational Issues in Psychological Science
Peter A Biro, Kerry V Fanson, Francesca Santostefano
Recent empirical and conceptual papers have highlighted the potential for metabolism to act as a proximate mechanism for behavior that could explain animal personality (consistency over time). Under this hypothesis, individuals with consistently high levels of behavioral activity should also have high resting metabolic rate (RMR) as it can reflect capacity to process food and generate energy. We tested for the predicted positive covariance between RMR and three behaviors that differ in energy demands in 30 male guppies, using multivariate mixed models; we repeatedly measured their activity (10 times each), courtship displays (nine times), voracity (10 times), and metabolism (four-times)...
September 2016: Ecology and Evolution
Tomoki Tamura, Taizo Hirata, Masahiro Tabata, Shiro Hinotsu, Akinobu Hamada, Takayuki Motoki, Takayuki Iwamoto, Taeko Mizoo, Tomohiro Nogami, Tadahiko Shien, Naruto Taira, Junji Matsuoka, Hiroyoshi Doihara
Docetaxel is a standard treatment for patients with advanced or recurrent breast cancer. The recommended dose is 60 to 100 mg/m2. Previous study have shown that the tumor response rates of patients who received docetaxel monotherapy at doses of 60, 75, and 100 mg/m2 were 22.1% , 23.3% , and 36.0% , respectively, and there was a significant relationship between the dose and response. In Europe and the United States, docetaxel is approved at a dose of 100 mg/m2, and Japanese guidelines also recommend a dose of 100 mg/m2...
October 2016: Acta Medica Okayama
Julian Savulescu, Karolina Wartolowska, Andy Carr
Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: (1) the presence of equipoise, defined as a lack of unbiased evidence for efficacy of an intervention; (2) clinically important research question; (3) the risk to patients is minimised and reasonable; (4) there is uncertainty about treatment allocation rather than deception; (5) there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and (6) ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool...
October 24, 2016: Journal of Medical Ethics
C Parkinson, P Constantin, C Goyal, C Hall
OBJECTIVES: This study aimed to investigate whether addition of an octadecene/maleic anhydride copolymer (O/MA) to a potassium nitrate (KNO3) dentifrice could facilitate delivery of potassium to dentine and enhance its efficacy in dentine hypersensitivity relief. METHODS: This was a randomised, examiner-blind, controlled, parallel group study in 139 healthy subjects with at ≥2 sensitive teeth. Assessment of dentine hypersensitivity to tactile (Yeaple probe) and evaporative (air) stimuli (Schiff Sensitivity Scale, visual analogue scale [VAS]) was carried out at baseline and after 1, 2, 4 and 8 weeks twice daily treatment with an experimental 5% KNO3/3% O/MA dentifrice, a comparator 5% KNO3 dentifrice (active comparator), a 0% KNO3/3% O/MA dentifrice (placebo) and a regular fluoride dentifrice (negative control)...
October 21, 2016: Journal of Dentistry
James A McCubrey, Kvin Lertpiriyapong, Timothy L Fitzgerald, Alberto M Martelli, Lucio Cocco, Dariusz Rakus, Agnieszka Gizak, Massimo Libra, Melchiorre Cervello, Guiseppe Montalto, Li V Yang, Stephen L Abrams, Linda S Steelman
TP53 is a critical tumor suppressor gene that regulates cell cycle progression, apoptosis, cellular senescence and many other properties critical for control of normal cellular growth and death. Due to the pleiotropic effects that TP53 has on gene expression and cellular physiology, mutations at this tumor suppressor gene result in diverse physiological effects. T53 mutations are frequently detected in numerous cancers. The expression of TP53 can be induced by various agents used to treat cancer patients such as chemotherapeutic drugs and ionizing radiation...
October 6, 2016: Advances in Biological Regulation
Brent A Moore, David A Fiellin, Christopher J Cutter, Frank D Buono, Declan T Barry, Lynn E Fiellin, Patrick G O'Connor, Richard S Schottenfeld
To determine whether treatment outcomes differed for prescription opioid and heroin use disorder patients, we conducted a secondary analysis of a 24-week (N=140) randomized trial of physician management (PM) or PM plus cognitive behavioral therapy (CBT) in primary care buprenorphine/naloxone treatment. Self-reported opioid use and urine toxicology analyses were obtained weekly. We examined baseline demographic differences between primary prescription opioid use patients (n=49) and primary heroin use patients (n=91) and evaluated whether treatment response differed by assigned condition...
December 2016: Journal of Substance Abuse Treatment
Cutter A Lindbergh, Catherine M Mewborn, Billy R Hammond, Lisa M Renzi-Hammond, Joanne M Curran-Celentano, L Stephen Miller
OBJECTIVES: It is well known that the carotenoids lutein (L) and zeaxanthin (Z) improve eye health and an accumulating evidence base suggests cognitive benefits as well. The present study investigated underlying neural mechanisms using functional magnetic resonance imaging (fMRI). It was hypothesized that lower L and Z concentrations would be associated with neurobiological inefficiency (i.e., increased activation) during cognitive performance. METHODS: Forty-three community-dwelling older adults (mean age=72 years; 58% female; 100% Caucasian) were asked to learn and recall pairs of unrelated words in an fMRI-adapted paradigm...
October 25, 2016: Journal of the International Neuropsychological Society: JINS
S R T Veerman, P F J Schulte, J B Deijen, L de Haan
BACKGROUND: In a recent placebo-controlled, double-blind crossover trial (n = 52), significant beneficial effects on memory (d = 0.30) and negative symptoms (d = 0.29) were found after 12 weeks of memantine augmentation in patients with clozapine-refractory schizophrenia. In this open-label 1-year extension study we report the long-term effects and tolerability of memantine add-on therapy to clozapine. METHOD: Completers of the first trial who experienced beneficial effects during 12 weeks of memantine treatment received memantine for 1 year...
October 25, 2016: Psychological Medicine
Cristina Scavone, Concetta Rafaniello, Liberata Sportiello, Liberato Berrino, Annalisa Capuano
No abstract text is available yet for this article.
October 25, 2016: Expert Review of Clinical Pharmacology
Angela M Hong, Ricardo E Vilain, Sarah Romanes, Jean Yang, Elizabeth Smith, Deanna Jones, Richard A Scolyer, C Soon Lee, Mei Zhang, Barbara Rose
In this study, we examined PD-L1 expression by immunohistochemistry in 99 patients with tonsillar cancer and known human papillomavirus (HPV) status to assess its clinical significance. We showed that the pattern of PD-L1 expression is strongly related to HPV status. The PD-L1 positivity rate was 83.3% in HPV-positive cases and 56.9% in HPV-negative cases (p < 0.05). Patients with HPV-positive/PD-L1-positive cancer had significantly better event free survival and overall survival compared with patients with HPV-negative/PD-L1-negative cancer...
October 20, 2016: Oncotarget
Chao-Ying Chen, Tonya L Rich, Jessica M Cassidy, Bernadette T Gillick
Transcranial magnetic stimulation (TMS) can be used as an assessment or intervention to evaluate or influence brain activity in children with hemiparetic cerebral palsy (CP) commonly caused by perinatal stroke. This communication report analyzed data from two clinical trials using TMS to assess corticospinal excitability in children and young adults with hemiparetic CP. The results of this communication revealed a higher probability of finding a motor evoked potential (MEP) on the non-lesioned hemisphere compared to the lesioned hemisphere (p = 0...
October 20, 2016: Brain Sciences
Alexander Rozental, Kristoffer Magnusson, Johanna Boettcher, Gerhard Andersson, Per Carlbring
Objective: Psychological treatments can relieve mental distress and improve well-being, and the dissemination of evidence-based methods can help patients gain access to the right type of aid. Meanwhile, Internet-based cognitive-behavioral therapy (ICBT) has shown promising results for many psychiatric disorders. However, research on the potential for negative effects of psychological treatments has been lacking. Method: An individual patient data meta-analysis of 29 clinical trials of ICBT (N = 2,866) was performed using the Reliable Change Index for each primary outcome measures to distinguish deterioration rates among patients in treatment and control conditions...
October 24, 2016: Journal of Consulting and Clinical Psychology
Prithviraj Bose, Srdan Verstovsek
INTRODUCTION: Primary myelofibrosis (PMF) is the least common but the most aggressive of the classic Philadelphia chromosome-negative myeloproliferative neoplasms. Survival is much shorter in PMF than in polycythemia vera (PV) or essential thrombocythemia (ET). Post-PV/ET myelofibrosis (MF) is clinically indistinguishable from PMF and approached similarly. AREAS COVERED: Current pharmacologic therapy of MF revolves around the Janus kinase 1/2 (JAK1/2) inhibitor ruxolitinib, which dramatically improves constitutional symptoms and splenomegaly in the majority of patients, and improves overall survival (OS)...
October 22, 2016: Expert Opinion on Pharmacotherapy
Alison M El Ayadi, Corinne H Rocca, Julia E Kohn, Denisse Velazquez, Maya Blum, Sara J Newmann, Cynthia C Harper
Long-acting reversible contraceptives (LARCs) are highly effective at preventing pregnancy but do not protect against sexually transmitted infection (STI). Recent efforts to improve access to intrauterine devices (IUDs) and implants have raised concerns about STI prevention and reduced condom use, particularly among teenagers and young women. We evaluated whether a provider-targeted intervention to increase LARC access negatively impacted dual method use and STI incidence among an at-risk patient population...
October 20, 2016: Preventive Medicine
L A Pérula-de Torres, V González-Blanco V, R Luque-Montilla, E Martín-Rioboó, M A Martínez-Adell, J Ruiz-de Castroviejo
INTRODUCTION: Atrial fibrillation (AF) is the most frequent arrhythmia in clinical practice and has important prognostic implications. The objective of this study was to demonstrate the validity and the reliability of taking the arterial pulse (TAP) in patients over 65 years for detecting in AF and other rhythm disorders. MATERIALS AND METHODS: A descriptive, observational, multicentre study to validate a diagnostic test within in a controlled clinical trial. SETTING: 39 Primary Care Centres in the Spanish National Health Service...
October 20, 2016: Semergen
Handoo Rhee, John Blazak, Chui Ming Tham, Keng Lim Ng, Benjamin Shepherd, Malcolm Lawson, John Preston, Ian Vela, Paul Thomas, Simon Wood
BACKGROUND: In this study, we prospectively evaluate the diagnostic potential of a gallium-68 (68Ga) prostate-specific membrane antigen (PSMA)-binding ligand and positron emission tomography (PET) in detecting metastatic lesions in patients with renal tumour. The secondary aim was to determine whether the findings would result in the alteration of patient management. RESULTS: Ten patients with renal lesion and potential metastatic disease on conventional imaging were recruited...
December 2016: EJNMMI Research
Renáta Kószó, Dóra Sántha, László Büdi, József Erfán, Károly Győrfy, Zsolt Horváth, Judit Kocsis, László Landherr, Erika Hitre, Károly Máhr, Gábor Pajkos, Zsuzsanna Pápai, Zsuzsanna Kahán
Due to the limited experience with capecitabine plus docetaxel (XT) combination in the first-line treatment of metastatic breast cancer in Hungary, the main objective of the study was to analyze the effectiveness and tolerability of XT therapy. A prospective, open-label, non-randomized, single-arm, multicenter, observational study was designed. All female patients were eligible whose metastatic breast cancer could be treated with the XT protocol according to the summary of product characteristics of the drugs...
October 22, 2016: Pathology Oncology Research: POR
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