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https://www.readbyqxmd.com/read/29031170/a-dose-escalation-study-of-bi-daily-once-weekly-oral-docetaxel-either-as-modradoc001-or-modradoc006-combined-with-ritonavir
#1
Vincent A de Weger, Frederik E Stuurman, Jeroen J M A Hendrikx, Johannes J Moes, Emilia Sawicki, Alwin D R Huitema, Bastiaan Nuijen, Bas Thijssen, Hilde Rosing, Marianne Keessen, Marja Mergui-Roelvink, Jos H Beijnen, Jan H M Schellens, Serena Marchetti
INTRODUCTION: Two solid dispersions of docetaxel (denoted ModraDoc001 capsule and ModraDoc006 tablet (both 10 mg)) were co-administered with 100 mg ritonavir (/r) and investigated in a bi-daily once weekly (BIDW) schedule. Safety, maximum tolerated dose (MTD), pharmacokinetics (PK) and preliminary activity were explored. METHODS: Adult patients with metastatic solid tumours were included in two dose-escalation arms. PK sampling was performed during the first week and the second or third week...
October 11, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29031158/a-potential-contribution-to-human-identification-using-peri-mortem-trauma-an-example-from-peru
#2
Jose P Baraybar
This is an exploratory study into the need for additional lines of forensic evidence in humanitarian cases using applied research. One hundred and twenty four, still unidentified terrorism inmates, were killed after surrendering to the Peruvian Army once it took control of the San Pedro-Lurigancho prison in Lima, Peru in 1986. Two questions are put forward: first, to what extent mechanism of injury (gunshot, blunt, sharp force) and bodily distribution of those injuries allow us to classify individuals into discrete sub-groups of people? The second question is to what respect can such a classification become an additional line of evidence assisting in generating hypotheses of identity regarding those individuals? The analysis of the 109 recovered bodies and their associated evidence show a sub group of four individuals differentiated from the rest based on the combination of injuries (gunshot and blunt force trauma), opposing trajectories and weapons...
September 21, 2017: Forensic Science International
https://www.readbyqxmd.com/read/29031111/immobilization-of-sugars-in-supermacroporous-cryogels-for-the-purification-of-lectins-by-affinity-chromatography
#3
Gabriel Ramos Ferreira Gonçalves, Olga Reinert Ramos Gandolfi, Leandro Soares Santos, Renata Cristina Ferreira Bonomo, Cristiane Martins Veloso, Lizzy Ayra Alcântara Veríssimo, Rafael da Costa Ilhéu Fontan
Lectins are glycoproteins that bind to carbohydrates or glycoconjugates by specific interactions. The specificity of lectins to various carbohydrates is a determinant factor in the choice of ligand for the chromatographic matrix when using chromatography as a lectin purification technique. In this work, the immobilization of three different aminated carbohydrates on the surface of macroporous polymeric cryogels was evaluated. Carbohydrates were immobilized on cryogel surfaces via the glutaraldehyde method to create spacer arms, reducing steric hindrance...
October 9, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29029352/patient-satisfaction-outcomes-after-robotic-arm-assisted-total-knee-arthroplasty-a-short-term-evaluation
#4
Robert C Marchand, Nipun Sodhi, Anton Khlopas, Assem A Sultan, Steven F Harwin, Arthur L Malkani, Michael A Mont
No abstract text is available yet for this article.
October 13, 2017: Journal of Knee Surgery
https://www.readbyqxmd.com/read/29029278/efficacy-and-safety-of-delafloxacin-compared-with-vancomycin-plus-aztreonam-for-acute-bacterial-skin-and-skin-structure-infections-a-phase-3-double-blind-randomized-study
#5
J Pullman, J Gardovskis, B Farley, E Sun, M Quintas, L Lawrence, R Ling, S Cammarata
Background: Delafloxacin is an investigational anionic fluoroquinolone in development for oral or intravenous administration for the treatment of infections caused by Gram-positive (including MRSA), Gram-negative, atypical and anaerobic organisms. Objectives: To establish the non-inferiority of delafloxacin compared with vancomycin plus aztreonam for the treatment of acute bacterial skin and skin structure infections and to compare the safety of the two antimicrobials...
October 5, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29029271/sequence-and-structural-diversity-of-mouse-y-chromosomes
#6
Andrew P Morgan, Pardo-Manuel de Villena Fernando
Over the 180 million years since their origin, the sex chromosomes of mammals have evolved a gene repertoire highly specialized for function in the male germline. The mouse Y chromosome is unique among mammalian Y chromosomes characterized to date in that it is large, gene-rich and euchromatic. Yet little is known about its diversity in natural populations. Here we take advantage of published whole-genome sequencing data to survey the diversity of sequence and copy number of sex-linked genes in three subspecies of house mice...
September 25, 2017: Molecular Biology and Evolution
https://www.readbyqxmd.com/read/29029185/patient-reported-outcomes-in-newly-diagnosed-early-rheumatoid-arthritis-patients-treated-to-target-with-a-tocilizumab-or-methotrexate-based-strategy
#7
Xavier M Teitsma, Johannes W G Jacobs, Paco M J Welsing, Attila Pethö-Schramm, Michelle E A Borm, Lidy Hendriks, Natasja H A M Denissen, Jacob M van Laar, Floris P J G Lafeber, Johannes W J Bijlsma
Objective: To evaluate the effect of initiation of tocilizumab, with or without MTX, compared with MTX alone on patient-reported outcomes (PROs), in DMARD-naïve patients with early RA. Methods: In U-Act-Early, patients initiated treat-to-target step-up MTX, tocilizumab or tocilizumab plus MTX therapy. PROs assessed included the Functional Assessment of Chronic Illness Therapy-Fatigue, 36-item Short Form (SF-36), five dimensional EuroQol (EQ-5D) and the Revised Illness Perception Questionnaire...
September 23, 2017: Rheumatology
https://www.readbyqxmd.com/read/29029033/trial-evaluating-ambulatory-therapy-of-travelers-diarrhea-treat-td-study-a-randomized-controlled-trial-comparing-3-single-dose-antibiotic-regimens-with-loperamide
#8
Mark S Riddle, Patrick Connor, Jamie Fraser, Chad K Porter, Brett Swierczewski, Emma J Hutley, Brook Danboise, Mark P Simons, Christine Hulseberg, Tahaniyat Lalani, Ramiro L Gutierrez, David R Tribble
Background: Recommended treatment for travelers' diarrhea includes the combination of an antibiotic, usually a fluoroquinolone or azithromycin, and loperamide for rapid resolution of symptoms. However, adverse events, postdose nausea with high-dose azithromycin, effectiveness of single-dose rifaximin, and emerging resistance to front-line agents are evidence gaps underlying current recommendations. Methods: A randomized, double-blind trial was conducted in 4 countries (Afghanistan, Djibouti, Kenya, and Honduras) between September 2012 and July 2015...
September 23, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29028973/safety-and-immunogenicity-of-newborn-mva85a-vaccination-and-selective-delayed-bacille-calmette-guerin-bcg-for-infants-of-hiv-infected-mothers-a-phase-2-randomized-controlled-trial
#9
Elisa Nemes, Anneke C Hesseling, Michele Tameris, Katya Mauff, Katrina Downing, Humphrey Mulenga, Penelope Rose, Marieke van der Zalm, Sharon Mbaba, Danelle Van As, Willem A Hanekom, Gerhard Walzl, Thomas J Scriba, Helen McShane, Mark Hatherill
Background: Vaccination of HIV-infected infants with bacille Calmette-Guérin (BCG) is contraindicated. HIV-exposed newborns need a new tuberculosis (TB) vaccination strategy that protects against TB early in life; and avoids the potential risk of BCG disease until after HIV infection has been excluded. Methods: This double-blind randomized controlled trial compared newborn MVA85A prime vaccination (1 x10 8 PFU) vs. Candin® control, followed by selective deferred BCG vaccination at 8 weeks of age for HIV-uninfected infants, and 12 months follow-up for safety and immunogenicity...
September 26, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29028696/brain-oxygen-optimization-in-severe-traumatic-brain-injury-phase-ii-a-phase-ii-randomized-trial
#10
David O Okonkwo, Lori A Shutter, Carol Moore, Nancy R Temkin, Ava M Puccio, Christopher J Madden, Norberto Andaluz, Randall M Chesnut, M Ross Bullock, Gerald A Grant, John McGregor, Michael Weaver, Jack Jallo, Peter D LeRoux, Dick Moberg, Jason Barber, Christos Lazaridis, Ramon R Diaz-Arrastia
OBJECTIVES: A relationship between reduced brain tissue oxygenation and poor outcome following severe traumatic brain injury has been reported in observational studies. We designed a Phase II trial to assess whether a neurocritical care management protocol could improve brain tissue oxygenation levels in patients with severe traumatic brain injury and the feasibility of a Phase III efficacy study. DESIGN: Randomized prospective clinical trial. SETTING: Ten ICUs in the United States...
November 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/29028233/ethics-in-public-health-call-for-shared-moral-public-health-literacy
#11
Els L M Maeckelberghe, Peter Schröder-Bäck
Public Health (PH) in Europe has become much more vocal about its moral understandings since 1992. The rising awareness that PH issues were inseparable from issues of human rights and social justice almost self-evidently directed the agenda of EUPHA and the European Public Health (EPH)-conferences. Problems of cultural and behavioural change, and environmental issues on a global scale were also added. The Section Ethics in PH invited the EPH community to join in 'arm chair thinking': coming together at conferences not only to share the 'how' and 'what' of PH research, practices and policies but also the 'why'...
October 1, 2017: European Journal of Public Health
https://www.readbyqxmd.com/read/29028054/extended-9-7%C3%A2-%C3%A2-nm-tuning-range-in-a-mopa-system-with-a-tunable-dual-grating-y-branch-laser
#12
Mahmoud Tawfieq, André Müller, Jörg Fricke, Pietro Della Casa, Peter Ressel, David Feise, Bernd Sumpf, Günther Tränkle
In this Letter, we present a tunable Y-branch hybrid master oscillator power amplifier (MOPA) with 5.5 W output power, emitting between 973.7 and 983.4 nm. The MO is a monolithic Y-branch distributed Bragg reflector (DBR) diode laser, which is collimated and coupled into a tapered amplifier using cylindrical microlenses in a compact 25  mm×25  mm conduction cooled laser package. The wavelength spacing between the two laser branches is 2.2 nm. Each branch can be electrically tuned by up to 7.5 nm of quasi-continuous wavelength tuning, which in combination covers up to 9...
October 15, 2017: Optics Letters
https://www.readbyqxmd.com/read/29027895/changes-in-foraminal-area-with-anterior-decompression-versus-keyhole-foraminotomy-in-the-cervical-spine-a-biomechanical-investigation
#13
Jacqueline Nguyen, Bryant Chu, Calvin C Kuo, Jeremi M Leasure, Christopher Ames, Dimitriy Kondrashov
OBJECTIVE Anterior cervical discectomy and fusion (ACDF) with or without partial uncovertebral joint resection (UVR) and posterior keyhole foraminotomy are established operative procedures to treat cervical disc degeneration and radiculopathy. Studies have demonstrated reliable results with each procedure, but none have compared the change in neuroforaminal area between indirect and direct decompression techniques. The purpose of this study was to determine which cervical decompression method most consistently increases neuroforaminal area and how that area is affected by neck position...
October 13, 2017: Journal of Neurosurgery. Spine
https://www.readbyqxmd.com/read/29027812/use-of-a-novel-remotely-connected-diabetes-management-system-is-associated-with-increased-treatment-satisfaction-reduced-diabetes-distress-and-improved-glycemic-control-in-individuals-with-insulin-treated-diabetes-first-results-from-the-personal-diabetes-management
#14
Pablo Mora, Ann Buskirk, Maureen Lyden, Christopher G Parkin, Lena Borsa, Bettina Petersen
BACKGROUND: The ability to automatically transfer data to clinicians and receive timely guidance in therapy adjustments through remote and in-office consults can positively impact patients' perceptions about quality of care, which is positively associated with clinical outcomes. We assessed the impact of using the Accu-Chek Connect diabetes management system on treatment satisfaction, diabetes distress, and glycemic control in adults with type 1 diabetes and insulin-treated type 2 diabetes...
October 13, 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/29027640/the-utility-of-botulinum-toxin-a-in-the-repair-of-distal-biceps-tendon-ruptures
#15
L S Khalil, R A Keller, N Mehran, N E Marshall, K Okoroha, N B Frisch, S P DeSilva
PURPOSE: The purpose of our study is to report the outcomes and complications in patients who underwent distal biceps tendon repair with the use of Botulinum toxin A (BoNT-A) as an adjunct to surgery. METHODS: A retrospective review of 14 patients who underwent 15 distal biceps tendon repairs was performed. All repaired tendons had their correlating muscle bellies injected intraoperatively with a mixture of 100U of BoNT-A and 10 ml of normal saline. Each patient was evaluated for surgical and post-operative complications and followed with Disabilities of the Arm, Shoulder and Hand (DASH) Disability Scores...
October 13, 2017: Musculoskeletal Surgery
https://www.readbyqxmd.com/read/29027598/a-randomized-phase-ii-study-of-weekly-paclitaxel-with-or-without-pelareorep-in-patients-with-metastatic-breast-cancer-final-analysis-of-canadian-cancer-trials-group-ind-213
#16
V Bernstein, S L Ellard, S F Dent, D Tu, M Mates, S K Dhesy-Thind, L Panasci, K A Gelmon, M Salim, X Song, M Clemons, D Ksienski, S Verma, C Simmons, H Lui, K Chi, H Feilotter, L J Hagerman, L Seymour
BACKGROUND: Pelareorep, a serotype 3 reovirus, has demonstrated preclinical and early clinical activity in breast cancer and synergistic cytotoxic activity with microtubule targeting agents. This multicentre, randomized, phase II trial was undertaken to evaluate the efficacy and safety of adding pelareorep to paclitaxel for patients with metastatic breast cancer (mBC). METHODS: Following a safety run-in of 7 patients, 74 women with previously treated mBC were randomized either to paclitaxel 80 mg/m(2) intravenously on days 1, 8, and 15 every 4 weeks plus pelareorep 3 × 10(10) TCID50 intravenously on days 1, 2, 8, 9, 15, and 16 every 4 weeks (Arm A) or to paclitaxel alone (Arm B)...
October 13, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29027591/clinical-toxicity-of-antibody-drug-conjugates-a-meta-analysis-of-payloads
#17
REVIEW
Joanna C Masters, Dana J Nickens, Dawei Xuan, Ronald L Shazer, Michael Amantea
Background Antibody drug conjugates (ADCs) utilize a monoclonal antibody to deliver a cytotoxic payload specifically to tumor cells, limiting exposure to healthy tissues. Major clinical toxicities of ADCs include hematologic, hepatic, neurologic, and ophthalmic events, which are often dose-limiting. These events may be off-target effects caused by premature release of payload in circulation. A meta-analysis was performed to summarize key clinical safety data for ADCs by payload, and data permitting, establish a dose-response model for toxicity incidence as a function of payload, dose/regimen, and cancer type...
October 13, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/29027509/multiply-adjusted-comparisons-a-meta-analysis-method-to-compare-single-arm-clinical-trial-data-to-literature-results-regarding-a-competitor
#18
Dietmar Boethig, Hartmut Hecker
Prospective randomized controlled trials are difficult to obtain if a promising new therapy has to be tested against seemingly obsolete alternatives. One method to address this problem is to compare the results of (multicentre) trials to literature results. However, previous treatment-era changes and population-dependent results complicate objective comparisons. The presented approach describes a method to objectify such comparisons in cases in which individual raw data regarding a new therapy have to be compared to summary results regarding a conventional alternative published in the literature...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/29027505/impact-of-non-uniform-correlation-structure-on-sample-size-and-power-in-multiple-period-cluster-randomised-trials
#19
J Kasza, K Hemming, R Hooper, Jns Matthews, A B Forbes
Stepped wedge and cluster randomised crossover trials are examples of cluster randomised designs conducted over multiple time periods that are being used with increasing frequency in health research. Recent systematic reviews of both of these designs indicate that the within-cluster correlation is typically taken account of in the analysis of data using a random intercept mixed model, implying a constant correlation between any two individuals in the same cluster no matter how far apart in time they are measured: within-period and between-period intra-cluster correlations are assumed to be identical...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/29027398/nutritional-status-cachexia-and-anorexia-in-women-with-peritoneal-metastasis-and-intraperitoneal-chemotherapy-a-longitudinal-analysis
#20
Ziad Hilal, Günther A Rezniczek, Robert Klenke, Askin Dogan, Clemens B Tempfer
OBJECTIVE: To describe the nutritional status of women with peritoneal metastasis (PM) from recurrent ovarian, fallopian, or peritoneal cancer and to assess longitudinal variations of the cachexia-anorexia syndrome (CAS) during palliative pressurized intraperitoneal aerosol chemotherapy (PIPAC). METHODS: Nutritional assessment included body mass index (BMI), bioelectrical impedance analysis (BIA), and blood chemistry. CAS presence/absence was recorded before and during repeated cycles (1-11) of PIPAC...
November 2017: Journal of Gynecologic Oncology
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