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https://www.readbyqxmd.com/read/29151047/interpretation-of-health-news-items-reported-with-or-without-spin-protocol-for-a-prospective-meta-analysis-of-16-randomised-controlled-trials
#1
Romana Haneef, Amélie Yavchitz, Philippe Ravaud, Gabriel Baron, Ivan Oranksy, Gary Schwitzer, Isabelle Boutron
INTRODUCTION: We aim to compare the interpretation of health news items reported with or without spin. 'Spin' is defined as a misrepresentation of study results, regardless of motive (intentionally or unintentionally) that overemphasises the beneficial effects of the intervention and overstates safety compared with that shown by the results. METHODS AND ANALYSIS: We have planned a series of 16 randomised controlled trials (RCTs) to perform a prospective meta-analysis...
November 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/29150937/cgmp-production-and-analysis-of-bg505-sosip-664-an-extensively-glycosylated-trimeric-hiv-1-envelope-glycoprotein-vaccine-candidate
#2
Antu K Dey, Albert Cupo, Gabriel Ozorowski, Vaneet K Sharma, Anna-Janina Behrens, Eden P Go, Thomas J Ketas, Anila Yasmeen, Per J Klasse, Eddy Sayeed, Heather Desaire, Max Crispin, Ian A Wilson, Rogier W Sanders, Thomas Hassell, Andrew Ward, John P Moore
We describe the properties of BG505 SOSIP.664 HIV-1 envelope glycoprotein trimers produced under current Good Manufacturing Practice (cGMP) conditions. These proteins are the first of a new generation of native-like trimers that are the basis for many structure-guided immunogen development programs aimed at devising how to induce broadly neutralizing antibodies (bNAbs) to HIV-1 by vaccination. The successful translation of this prototype demonstrates the feasibility of producing similar immunogens on an appropriate scale and of an acceptable quality for Phase I experimental medicine clinical trials...
November 18, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/29150161/improved-pharmacodynamic-pd-assessment-of-low-dose-parp-inhibitor-pd-activity-for-radiotherapy-and-chemotherapy-combination-trials
#3
Rosemarie de Haan, Dick Pluim, Baukelien van Triest, Michel van den Heuvel, Heike Peulen, Damien van Berlo, Jay George, Marcel Verheij, Jan H M Schellens, Conchita Vens
BACKGROUND: PARP inhibitors are currently evaluated in combination with radiotherapy and/or chemotherapy. As sensitizers, PARP inhibitors are active at very low concentrations therefore requiring highly sensitive pharmacodynamic (PD) assays. Current clinical PD-assays partly fail to provide such sensitivities. The aim of our study was to enable sensitive PD evaluation of PARP inhibitors for clinical sensitizer development. MATERIAL AND METHODS: PBMCs of healthy individuals and of olaparib and radiotherapy treated lung cancer patients were collected for ELISA-based PD-assays...
November 14, 2017: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/29149911/the-analysis-of-novel-microrna-mimic-sequences-in-cancer-cells-reveals-lack-of-specificity-in-stem-loop-rt-qpcr-based-microrna-detection
#4
Patrick Winata, Marissa Williams, Eileen McGowan, Najah Nassif, Nico van Zandwijk, Glen Reid
OBJECTIVE: MicroRNAs are frequently downregulated in cancer, and restoring expression has tumour suppressive activity in tumour cells. Our recent phase I clinical trial investigated microRNA-based therapy in patients with malignant pleural mesothelioma. Treatment with TargomiRs, microRNA mimics with novel sequence packaged in EGFR antibody-targeted bacterial minicells, revealed clear signs of clinical activity. In order to detect delivery of microRNA mimics to tumour cells in future clinical trials, we tested hydrolysis probe-based assays specific for the sequence of the novel mimics in transfected mesothelioma cell lines using RT-qPCR...
November 17, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/29149909/testing-the-implementation-and-sustainment-facilitation-isf-strategy-as-an-effective-adjunct-to-the-addiction-technology-transfer-center-attc-strategy-study-protocol-for-a-cluster-randomized-trial
#5
Bryan R Garner, Mark Zehner, Mathew R Roosa, Steve Martino, Heather J Gotham, Elizabeth L Ball, Patricia Stilen, Kathryn Speck, Denna Vandersloot, Traci R Rieckmann, Michael Chaple, Erika G Martin, David Kaiser, James H Ford
BACKGROUND: Improving the extent to which evidence-based practices (EBPs)-treatments that have been empirically shown to be efficacious or effective-are integrated within routine practice is a well-documented challenge across numerous areas of health. In 2014, the National Institute on Drug Abuse funded a type 2 effectiveness-implementation hybrid trial titled the substance abuse treatment to HIV Care (SAT2HIV) Project. Aim 1 of the SAT2HIV Project tests the effectiveness of a motivational interviewing-based brief intervention (MIBI) for substance use as an adjunct to usual care within AIDS service organizations (ASOs) as part of its MIBI Experiment...
November 17, 2017: Addiction Science & Clinical Practice
https://www.readbyqxmd.com/read/29149855/increasing-upper-limb-training-intensity-in-chronic-stroke-using-embodied-virtual-reality-a-pilot-study
#6
Daniel Perez-Marcos, Odile Chevalley, Thomas Schmidlin, Gangadhar Garipelli, Andrea Serino, Philippe Vuadens, Tej Tadi, Olaf Blanke, José D R Millán
BACKGROUND: Technology-mediated neurorehabilitation is suggested to enhance training intensity and therefore functional gains. Here, we used a novel virtual reality (VR) system for task-specific upper extremity training after stroke. The system offers interactive exercises integrating motor priming techniques and embodied visuomotor feedback. In this pilot study, we examined (i) rehabilitation dose and training intensity, (ii) functional improvements, and (iii) safety and tolerance when exposed to intensive VR rehabilitation...
November 17, 2017: Journal of Neuroengineering and Rehabilitation
https://www.readbyqxmd.com/read/29149401/introduction-how-we-encountered-tctp-and-our-purpose-in-studying-it
#7
Adam Telerman, Robert Amson
In this brief introduction, we describe our encounter with TCTP. Back in 2000, we discovered TCTP in two quite different ways: first, we looked at protein partners of TSAP6 and one of them was TCTP. Then, in collaboration with Sidney Brenner, we performed a high-throughput differential screening comparing the parental cancer cells with revertants. The results indicated that TCTP was of the most differentially expressed genes. These two approaches were carried out only months apart. They guided our research and led to the discoveries of drugs that inhibit the function of TCTP...
2017: Results and Problems in Cell Differentiation
https://www.readbyqxmd.com/read/29147617/phase-i-trial-of-anti-gd2-monoclonal-antibody-hu3f8-plus-gm-csf-impact-of-body-weight-immunogenicity-and-anti-gd2-response-on-pharmacokinetics-and-survival
#8
Irene Y Cheung, Brian H Kushner, Shakeel Modak, Ellen M Basu, Stephen S Roberts, Nai-Kong V Cheung
Fifty-seven stage 4 patients with refractory/relapsed neuroblastoma were enrolled in a phase I trial (Clinicaltrials.gov NCT01757626) using humanized anti-GD2 monoclonal antibody hu3F8 in combination with granulocyte-macrophage colony-stimulating factor. The influence of body weight and human anti-human antibody (HAHA) on the pharmacokinetics (PK) of hu3F8, and the effect of de novo anti-GD2 response on patient outcome were explored. Serum samples before hu3F8 infusion, and serially up to day 12 during treatment cycle #1, and at 5 min after each hu3F8 infusion for all subsequent cycles were collected...
2017: Oncoimmunology
https://www.readbyqxmd.com/read/29146565/development-and-usability-testing-of-a-computer-tailored-decision-support-tool-for-lung-cancer-screening-study-protocol
#9
Lisa Carter-Harris, Robert Skipworth Comer, Anurag Goyal, Emilee Christine Vode, Nasser Hanna, DuyKhanh Ceppa, Susan M Rawl
BACKGROUND: Awareness of lung cancer screening remains low in the screening-eligible population, and when patients visit their clinician never having heard of lung cancer screening, engaging in shared decision making to arrive at an informed decision can be a challenge. Therefore, methods to effectively support both patients and clinicians to engage in these important discussions are essential. To facilitate shared decision making about lung cancer screening, effective methods to prepare patients to have these important discussions with their clinician are needed...
November 16, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/29145737/pembrolizumab-as-first-line-therapy-for-metastatic-non-small-cell-lung-cancer
#10
Martin Reck
This review describes trials evaluating the monoclonal antibody pembrolizumab (an immunotherapy that blocks the interaction between programmed death-1 and programmed death-ligand 1 and 2 [PD-L1/PD-L2]) as first-line therapy for advanced non-small-cell lung cancer (NSCLC). In the Phase III KEYNOTE-024 study, pembrolizumab monotherapy significantly improved progression-free survival (primary end point) and overall survival, and was associated with fewer adverse events compared with platinum-based chemotherapy in patients with NSCLC with PD-L1 expression on ≥50% of tumor cells...
November 17, 2017: Immunotherapy
https://www.readbyqxmd.com/read/29145561/clinical-significance-of-cd73-in-triple-negative-breast-cancer-multiplex-analysis-of-a-phase-iii-clinical-trial
#11
L Buisseret, S Pommey, B Allard, S Garaud, M Bergeron, I Cousineau, L Ameye, Y Bareche, M Paesmans, J P A Crown, A Di Leo, S Loi, M Piccart-Gebhart, K Willard-Gallo, C Sotiriou, J Stagg
Background: CD73 is an ecto-enzyme that promotes tumor immune escape through the production of immunosuppressive extracellular adenosine in the tumor microenvironment. Several CD73 inhibitors and adenosine receptor antagonists are being evaluated in phase I clinical trials. Patients and methods: Full-face sections from formalin-fixed paraffin-embedded primary breast tumors from 122 samples of triple-negative breast cancer from the BIG 02-98 adjuvant phase III clinical trial were included in our analysis...
November 14, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29143726/recent-advances-in-vesicular-stomatitis-virus-based-oncolytic-virotherapy-a-5-year-update
#12
Sébastien A Felt, Valery Z Grdzelishvili
Oncolytic virus (OV) therapy is an anti-cancer approach that uses viruses that preferentially infect, replicate in and kill cancer cells. Vesicular stomatitis virus (VSV, a rhabdovirus) is an OV that is currently being tested in the USA in several phase I clinical trials against different malignancies. Several factors make VSV a promising OV: lack of pre-existing human immunity against VSV, a small and easy to manipulate genome, cytoplasmic replication without risk of host cell transformation, independence of cell cycle and rapid growth to high titres in a broad range of cell lines facilitating large-scale virus production...
November 16, 2017: Journal of General Virology
https://www.readbyqxmd.com/read/29143400/pharmacokinetics-of-concentrated-naloxone-nasal-spray-for-opioid-overdose-reversal-phase-i-healthy-volunteer-study
#13
Rebecca McDonald, Ulrike Lorch, Jo Woodward, Björn Bosse, Helen Dooner, Gill Mundin, Kevin Smith, John Strang
BACKGROUND AND AIMS: Take-home naloxone can prevent death from heroin/opioid overdose, but pre-provision is difficult because naloxone is usually given by injection. Non-injectable alternatives, including naloxone nasal sprays, are currently being developed. To be effective, the intranasal (i.n.) spray dose must be adequate but not excessive, and early absorption must be comparable to intramuscular (i.m.) injection. We report on the pharmacokinetics (PK) of a specially produced concentrated novel nasal spray...
November 16, 2017: Addiction
https://www.readbyqxmd.com/read/29142605/aviscumine-a-recombinant-ribosomal-inhibitor-increases-the-antitumor-activity-of-natural-killer-cells
#14
Gabriele Gamerith, Arno Amann, Bettina Schenk, Thomas Auer, Hans Lentzen, Dirk O Mügge, Katharina M Cima, Judith Löffler-Ragg, Wolfgang Hilbe, Heinz Zwierzina
Aviscumine, a recombinant lectin I, has been identified as an immunomodulatory agent within a new class of ribotoxic stress-inducing anticancer substances that have demonstrated efficacy in phase I/II trials. The aim of the present study was to elucidate the presumed effect of aviscumine on enhancing human natural killer (NK) cell antitumor cytotoxicity. To measure the effect of aviscumine on human NK cell cytotoxicity, chromium-51-release assays against K-562 cells were performed with isolated NK cells from the whole blood of 34 healthy volunteers...
November 2017: Oncology Letters
https://www.readbyqxmd.com/read/29142090/virtual-reality-training-for-upper-extremity-in-subacute-stroke-virtues-a-multicenter-rct
#15
Iris Brunner, Jan Sture Skouen, Håkon Hofstad, Jörg Aßmus, Frank Becker, Anne-Marthe Sanders, Hanne Pallesen, Lola Qvist Kristensen, Marc Michielsen, Liselot Thijs, Geert Verheyden
OBJECTIVE: To compare the effectiveness of upper extremity virtual reality rehabilitation training (VR) to time-matched conventional training (CT) in the subacute phase after stroke. METHODS: In this randomized, controlled, single-blind phase III multicenter trial, 120 participants with upper extremity motor impairment within 12 weeks after stroke were consecutively included at 5 rehabilitation institutions. Participants were randomized to either VR or CT as an adjunct to standard rehabilitation and stratified according to mild to moderate or severe hand paresis, defined as ≥20 degrees wrist and 10 degrees finger extension or less, respectively...
November 15, 2017: Neurology
https://www.readbyqxmd.com/read/29142012/a-transcatheter-interatrial-shunt-device-for-the-treatment-of-heart-failure-with-preserved-ejection-fraction-reduce-lap-hf-i-a-phase-2-randomized-sham-controlled-trial
#16
Ted Feldman, Laura Mauri, Rami Kahwash, Sheldon Litwin, Mark J Ricciardi, Pim van der Harst, Martin Penicka, Peter S Fail, David M Kaye, Mark C Petrie, Anupam Basuray, Scott L Hummel, Rhondalyn Forde-McLean, Christopher D Nielsen, Scott Lilly, Joseph M Massaro, Daniel Burkhoff, Sanjiv J Shah
Background -In non-randomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), less symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and mid-range or preserved ejection fraction (EF ≥ 40%). We conducted the first randomized, sham-controlled trial to evaluate the IASD in HF with EF ≥ 40%. Methods -REDUCE LAP-HF I was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association (NYHA) class III or ambulatory class IV HF, EF ≥ 40%, exercise PCWP ≥ 25 mmHg, and PCWP-right atrial pressure gradient ≥ 5 mmHg...
November 15, 2017: Circulation
https://www.readbyqxmd.com/read/29141919/rare-tumors-in-kids-may-respond-to-tazemetostat
#17
(no author information available yet)
In a phase I trial of the EZH2 inhibitor tazemetostat, children with INI1-deficient tumors-including relapsed or refractory malignant rhabdoid tumors, atypical teratoid rhabdoid tumors, epithelioid sarcomas, and poorly differentiated chordomas-responded well to treatment, with some experiencing durable responses.
November 15, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/29141662/safety-and-tolerability-of-intradiscal-implantation-of-combined-autologous-adipose-derived-mesenchymal-stem-cells-and-hyaluronic-acid-in-patients-with-chronic-discogenic-low-back-pain-1-year-follow-up-of-a-phase-i-study
#18
Hemant Kumar, Doo-Hoe Ha, Eun-Jong Lee, Jun Hee Park, Jeong Hyun Shim, Tae-Keun Ahn, Kyoung-Tae Kim, Alexander E Ropper, Seil Sohn, Chung-Hun Kim, Devang Kashyap Thakor, Soo-Hong Lee, In-Bo Han
BACKGROUND: Adipose tissue-derived mesenchymal stem cells (AT-MSCs) offer potential as a therapeutic option for chronic discogenic low back pain (LBP) because of their immunomodulatory functions and capacity for cartilage differentiation. The goal of this study was to assess the safety and tolerability of a single intradiscal implantation of combined AT-MSCs and hyaluronic acid (HA) derivative in patients with chronic discogenic LBP. METHODS: We performed a single-arm phase I clinical trial with a 12-month follow-up and enrolled 10 eligible chronic LBP patients...
November 15, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/29140897/psychological-and-psychophysiological-effects-of-recuperative-music-postexercise
#19
Costas I Karageorghis, Andrew C Bruce, Suzanne T Pottratz, Rebecca C Stevens, Marcelo Bigliassi, Mark Hamer
PURPOSE: Few studies have examined the psychological and psychophysiological effects of recuperative music following exhaustive exercise. The main purpose of the present study was to examine the effects of two music conditions compared with a no-music control on psychological and psychophysiological recovery processes post-exercise. METHODS: A randomized, fully counterbalanced, crossover design was used. Core affect, salivary cortisol, heart rate, and blood pressure were measured before exhaustive exercise, immediately after, and in 10-, 20-, and 30-min intervals during passive recovery (21 women and 21 men; 20...
November 15, 2017: Medicine and Science in Sports and Exercise
https://www.readbyqxmd.com/read/29140138/cox-2-expression-and-effects-of-celecoxib-in-addition-to-standard-chemotherapy-in-advanced-non-small-cell-lung-cancer
#20
Miklos Gulyas, Johanna Sofia Margareta Mattsson, Andrea Lindgren, Lars Ek, Kristina Lamberg Lundström, Annelie Behndig, Erik Holmberg, Patrick Micke, Bengt Bergman
AIM: Inhibition of cyclooxygenase-2 (COX-2) is proposed as a treatment option in several cancer types. However, in non-small cell lung cancer (NSCLC), phase III trials have failed to demonstrate a benefit of adding COX-2 inhibitors to standard chemotherapy. The aim of this study was to analyze COX-2 expression in tumor and stromal cells as predictive biomarker for COX-2 inhibition. METHODS: In a multicenter phase III trial, 316 patients with advanced NSCLC were randomized to receive celecoxib (400 mg b...
November 15, 2017: Acta Oncologica
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