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https://www.readbyqxmd.com/read/29776892/technique-for-the-administration-of-high-dose-rate-brachytherapy-to-the-bile-duct-using-a-nasobiliary-catheter
#1
Christopher L Deufel, Keith M Furutani, Robert A Dahl, Michael P Grams, Luke B McLemore, Christopher L Hallemeier, Michelle Neben-Wittich, James A Martenson, Michael G Haddock
PURPOSE: Cholangiocarcinoma patients who are potential candidates for liver transplantation may be treated with high-dose-rate (HDR) brachytherapy using a minimally invasive nasobiliary catheter in an effort to escalate the radiotherapy dose to the tumor and maximize local control rates. This work describes the equipment, procedures, and quality assurance (QA) that enables successful administration. METHODS AND MATERIALS: This work describes the nasobiliary catheter placement, simulation, treatment planning, treatment delivery, and QA...
May 16, 2018: Brachytherapy
https://www.readbyqxmd.com/read/29776750/safety-and-immunogenicity-of-a-vi-dt-typhoid-conjugate-vaccine-phase-i-trial-in-healthy-filipino-adults-and-children
#2
Maria Rosario Capeding, Samuel Teshome, Tarun Saluja, Khalid Ali Syed, Deok Ryun Kim, Ju Yeon Park, Jae Seung Yang, Yang Hee Kim, Jiwook Park, Sue-Kyoung Jo, Yun Chon, Sudeep Kothari, Seon-Young Yang, Dong Soo Ham, Ji Hwa Ryu, Hee-Seong Hwang, Ju-Hwan Mun, Julia Lynch, Jerome Kim, Hun Kim, Jean-Louis Excler, Sushant Sahastrabuddhe
BACKGROUND: Typhoid fever remains a major public health problem in low- and middle-income countries where children aged 2-14 years bear the greatest burden. Vi polysaccharide is poorly immunogenic in children <2 years of age, and protection in adults is modest. The limitations of Vi polysaccharide vaccines can be overcome by conjugation of the Vi to a carrier protein. A typhoid conjugate vaccine composed of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) has been developed...
May 15, 2018: Vaccine
https://www.readbyqxmd.com/read/29776383/escalate-adaptive-treatment-approach-for-adolescents-and-adults-with-adhd-study-protocol-for-a-randomized-controlled-trial
#3
Toivo Zinnow, Tobias Banaschewski, Andreas J Fallgatter, Carolin Jenkner, Florence Philipp-Wiegmann, Alexandra Philipsen, Wolfgang Retz, Esther Sobanski, Johannes Thome, Michael Rösler
BACKGROUND: Over the last decade, a wide range of attention-deficit/hyperactivity disorder (ADHD) treatment approaches for adults, including both pharmacological interventions and psychosocial treatments, have been proposed and observed to be efficient. In practice, individual treatment concepts are based on results of clinical studies as well as international guidelines (NICE Guidelines) that recommend a step-by-step treatment approach. Since the evidence supporting this approach is limited, the aim of the present study is to determine an optimal intervention regarding severity levels of ADHD symptomatology conducting a randomized controlled trial...
May 18, 2018: Trials
https://www.readbyqxmd.com/read/29775206/prospective-determination-of-aspirin-sensitivity-in-patients-resistant-to-low-dose-aspirin-a-proof-of-concept-study
#4
Erica S Westphal, Michelle Rainka, Michelle Amsler, Traci Aladeen, Caitlin Wisniewski, Vernice Bates, Fran M Gengo
This study tested the capability of an assay to predict aspirin response and reduce ischemic events, and healthcare costs, and delays to optimal treatment. Patients who needed aspirin in the course of normal medical care were included. Patients were excluded if they had disorders affecting platelet function, alcohol use within 24 hours of a test, or NSAID use. Dose escalation of chewable aspirin from 81 mg, to 162 mg, to 325 mg daily occurred based on the results of whole blood impedance aggregation testing to the agonists, collagen (1ug/mL, 5 ug/mL) and arachidonate (0...
May 18, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29774396/tumor-volume-as-a-prognostic-marker-in-p16-positive-and-p16-negative-oropharyngeal-cancer-patients-treated-with-definitive-intensity-modulated-radiotherapy
#5
Timo Carpén, Kauko Saarilahti, Caj Haglund, Antti Markkola, Jussi Tarkkanen, Jaana Hagström, Petri Mattila, Antti Mäkitie
PURPOSE: To investigate the impact of primary gross tumor volume (pGTV) and nodal gross tumor volume (nGTV) in oropharyngeal squamous cell carcinoma (OPSCC) and the difference in their role between human papillomavirus (HPV)-positive and HPV-negative patients. METHODS: The patient cohort consists of 91 OPSCC patients treated with definitive radiochemotherapy or radiotherapy using intensity-modulated radiotherapy (IMRT). All patients had a minimum follow-up of 31 months...
May 17, 2018: Strahlentherapie und Onkologie: Organ der Deutschen Röntgengesellschaft ... [et Al]
https://www.readbyqxmd.com/read/29774052/therapeutic-drug-monitoring-of-vedolizumab-in-inflammatory-bowel-disease-current-data-and-future-directions
#6
REVIEW
Mark G Ward, Miles P Sparrow, Xavier Roblin
The introduction of vedolizumab, a lymphocyte adhesion inhibitor, has expanded the relatively limited therapeutic armamentarium available for Crohn's disease and ulcerative colitis. Despite its effectiveness, both primary nonresponse and secondary loss of response to vedolizumab do occur, as is observed with the use of anti-tumour necrosis factor (TNF) therapy. Further, in a proportion, onset of efficacy may be relatively slow. A large body of data support an exposure-response relationship with anti-TNF drug levels, which has led to therapeutic drug monitoring becoming incorporated into everyday clinical management...
2018: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/29773772/promoting-scientific-cooperation-in-times-of-diplomatic-challenges-sustained-partnership-between-the-cuban-academy-of-sciences-and-the-american-association-for-the-advancement-of-science
#7
Sergio Jorge-Pastrana, Marga Gual-Soler, Tom C Wang
Scientific research cooperation between Cuba and the USA has a long history that dates back to the 19th century. For the past 200 years, the two countries' relationship has been subject to complex economic, political and social forces. In the second half of the 20th century, the Cuban revolution and the subsequent escalation of the US government embargo impacted every aspect of Cuban life. While science was no exception, scientific interactions never ceased. Over the past decade, scientific cooperation-led and facilitated by scientific organizations such as the Cuban Academy of Sciences, the American Association for the Advancement of Science and others-has steadily increased to address ever more critical issues facing both countries...
April 2018: MEDICC Review
https://www.readbyqxmd.com/read/29773661/phase-i-study-of-oncolytic-vaccinia-virus-gl-onc1-in-patients-with-peritoneal-carcinomatosis
#8
Ulrich M Lauer, Martina Schell, Julia Beil, Susanne Berchtold, Ursula Koppenhöfer, Jörg Glatzle, Alfred Königsrainer, Robert Möhle, Dominik Nann, Falko Fend, Christina Pfannenberg, Michael Bitzer, Nisar P Malek
OBJECTIVE: Peritoneal carcinomatosis (PC) is common in advanced tumor stages or disease recurrence arising from gastrointestinal cancers, gynecologic malignancies, or primary peritoneal carcinoma. Since current therapies are mostly ineffective, new thera-peutic approaches are needed. Here, we report on a phase I study designed to assess safety, MTD, and anti-tumor activity of intra-peri-toneal (i.p.) administration of oncolytic vaccinia virus GL-ONC1 in advanced stage PC patients. DESIGN: GL-ONC1 was administered i...
May 17, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29773602/clofarabine-high-dose-cytarabine-and-liposomal-daunorubicin-in-pediatric-relapsed-refractory-acute-myeloid-leukemia-a-phase-ib-study
#9
Natasha K A van Eijkelenburg, Mareike Rasche, Essam Ghazaly, Michael N Dworzak, Thomas Klingebiel, Claudia Rossig, Guy Leverger, Jan Stary, Eveline S J M de Bont, Dana A Chitu, Yves Bertrand, Benoit Brethon, Brigitte Strahm, Inge M van der Sluis, Gertjan J L Kaspers, Dirk Reinhardt, C Michel Zwaan
Survival in children with relapsed/refractory acute myeloid leukemia is unsatisfactory. Treatment consists of one course fludarabine, cytarabine and liposomal daunorubicin, followed by fludarabine and cytarabine and stem-cell transplantation. Study ITCC 020/I-BFM 2009-02 aimed to identify the recommended phase 2 dose of clofarabine replacing fludarabine in the abovementioned combination regimen (3+3 design). Escalating dose-levels of clofarabine (20-40mg/m2/day x5days) and liposomal daunorubicin (40-0mg/m2/day) were administered with cytarabine (2g/m2/day x5days)...
May 17, 2018: Haematologica
https://www.readbyqxmd.com/read/29772497/the-role-of-the-vasopressin-system-and-dopamine-d1-receptors-in-the-effects-of-social-housing-condition-on-morphine-reward
#10
M L Shawn Bates, Rebeca S Hofford, Michael A Emery, Paul J Wellman, Shoshana Eitan
BACKGROUND: The association with opioid-abusing individuals or even the perception of opioid abuse by peers are risk factors for the initiation and escalation of abuse. Similarly, we demonstrated that morphine-treated animals housed with only morphine-treated animals (referred to as morphine only) acquire morphine conditioned place-preference (CPP) more readily than morphine-treated animals housed with drug-naïve animals (referred to as morphine cage-mates). However, the molecular mechanisms underlying these effects are still elusive...
April 22, 2018: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/29772044/a-phase-1-open-label-dose-escalation-trial-to-investigate-safety-and-tolerability-of-single-intravitreous-injections-of-icon-1-targeting-tissue-factor-in-wet-amd
#11
John A Wells, Christine R Gonzales, Brian B Berger, Victor H Gonzalez, Brian D Sippy, Gabriela Burian
BACKGROUND AND OBJECTIVE: This phase 1 study evaluated the safety and tolerability of single intravitreous injections (IVIs) of ICON-1 (Iconic Therapeutics, South San Francisco, CA) in patients with neovascular age-related macular degeneration (nAMD). ICON-1 is a modified factor VIIa protein linked with the Fc portion of a human immunoglobulin G1. The molecule binds tissue factor overexpressed on choroidal neovascularization (CNV) in AMD. PATIENTS AND METHODS: Open-label, interventional, dose-escalation trial in 18 patients with CNV due to AMD, with six patients per dose cohort...
May 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/29771201/attachment-and-jealousy-understanding-the-dynamic-experience-of-jealousy-using-the-response-escalation-paradigm
#12
Chloe O Huelsnitz, Allison K Farrell, Jeffry A Simpson, Vladas Griskevicius, Ohad Szepsenwol
Jealousy is a complex, dynamic experience that unfolds over time in relationship-threatening situations. Prior research has used retrospective reports that cannot disentangle initial levels and change in jealousy in response to escalating threat. In three studies, we examined responses to the Response Escalation Paradigm (REP)-a 5-stage hypothetical scenario in which individuals are exposed to increasing levels of relationship threat-as a function of attachment orientations. Highly anxious individuals exhibited hypervigilant, slow escalation response patterns, interfered earlier in the REP, felt more jealousy, sadness, and worry when they interfered, and wanted to engage in more vigilant, destructive, and passive behaviors aimed at their partner...
April 1, 2018: Personality & Social Psychology Bulletin
https://www.readbyqxmd.com/read/29769386/global-acceptance-of-biosimilars-importance-of-regulatory-consistency-education-and-trust
#13
REVIEW
Eduardo Cazap, Ira Jacobs, Ali McBride, Robert Popovian, Karol Sikora
Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics...
May 16, 2018: Oncologist
https://www.readbyqxmd.com/read/29769209/time-to-event-bayesian-optimal-interval-design-to-accelerate-phase-i-trials
#14
Ying Yuan, Ruitao Lin, Daniel Li, Lei Nie, Katherine E Warren
Late-onset toxicity is common for novel molecularly targeted agents and immunotherapy. It causes major logistic difficulty for existing adaptive phase I trial designs, which require the observance of toxicity early enough to apply dose escalation rules for new patients. The same logistic difficulty arises when the accrual is rapid. We propose the time-to-event Bayesian optimal interval (TITE-BOIN) design to accelerate phase I trials by allowing for real-time dose assignment decisions for new patients while some enrolled patients' toxicity data are still pending...
May 16, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29769074/delay-in-reviewing-test-results-prolongs-hospital-length-of-stay-a-retrospective-cohort-study
#15
Mei-Sing Ong, Farah Magrabi, Enrico Coiera
BACKGROUND: Failure in the timely follow-up of test results has been widely documented, contributing to delayed medical care. Yet, the impact of delay in reviewing test results on hospital length of stay (LOS) has not been studied. We examine the relationship between laboratory tests review time and hospital LOS. METHODS: A retrospective cohort study of inpatients admitted to a metropolitan teaching hospital in Sydney, Australia, between 2011 and 2012 (n = 5804)...
May 16, 2018: BMC Health Services Research
https://www.readbyqxmd.com/read/29769060/biopro-rcmi-1505-trial-multicenter-study-evaluating-the-use-of-a-biodegradable-balloon-for-the-treatment-of-intermediate-risk-prostate-cancer-by-intensity-modulated-radiotherapy-study-protocol
#16
David Pasquier, Emilie Bogart, François Bonodeau, Thomas Lacornerie, Eric Lartigau, Igor Latorzeff
BACKGROUND: Prospective trials have demonstrated the advantage of dose-escalated radiotherapy for the biochemical and clinical control of intermediate risk prostate cancer. Dose escalation improves outcomes but increases risks of urinary and bowel toxicity. Recently the contribution of "spacers" positioned in the septum between the rectum and the prostate could improve the functional results of intensity modulated radiation therapy (IMRT). To date most of the evaluated devices were polyethylen glycol (PEG) and hyaluronic acid (HA)...
May 16, 2018: BMC Cancer
https://www.readbyqxmd.com/read/29768940/risk-based-monitoring-rbm-implementation-challenges-and-potential-solutions
#17
Nimita Limaye, Veena Jaguste
Risk-based monitoring (RBM) has disrupted the clinical trial industry, challenging conventional monitoring norms, business processes, and organizational structures. Endorsed by regulators and leading industry forums, and further driven by escalating drug development costs and enabling technology shifts making data available real time, the industry is moving from a mode of recalcitrance to acceptance. The effective implementation of RBM requires delicately interweaving changes in technology, processes, people, and perspectives...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29768280/phase-i-ii-trial-of-chemotherapy-with-docetaxel-cisplatin-and-s-1-for-unresectable-advanced-squamous-cell-carcinoma-of-the-esophagus
#18
Toshiyasu Ojima, Masaki Nakamura, Mikihito Nakamori, Masahiro Katsuda, Keiji Hayata, Shimpei Maruoka, Toshio Shimokawa, Hiroki Yamaue
Our previous trial with a docetaxel, cisplatin, and 5-fluorouracil (DCF) regimen showed high response rates in metastatic squamous cell carcinoma of the esophagus (SCCE). The observed increased toxicity of the DCF regimen, however, was clinically harmful. S-1, an oral anticancer drug, has been approved as a combination therapy for SCCE, and alternate-day regimen with S-1 has shown lower levels of toxicity. This prospective single-center phase I/II trial examines the efficacy and toxicity of a combination of docetaxel, cisplatin, and an alternate-day regimen of S-1 (modified DCS) for patients with metastatic SCCE...
May 16, 2018: Oncology
https://www.readbyqxmd.com/read/29766337/a-phase-i-trial-to-determine-safety-and-pharmacokinetics-of-aslan002-an-oral-met-superfamily-kinase-inhibitor-in-patients-with-advanced-or-metastatic-solid-cancers
#19
Aflah Roohullah, Adam Cooper, Anna J Lomax, Jennifer Aung, Alan Barge, Lilian Chow, Mark McHale, Jayesh Desai, James R Whittle, Ben Tran, Paul de Souza, Lisa G Horvath
Background The MET tyrosine kinase and its ligand, hepatocyte growth factor (HGF) also known as scatter factor, are associated with tumourigenesis and metastasis by promotion of scattering, proliferation, angiogenesis, motility and invasion. ASLAN-002 is a potent inhibitor of MET as well as related kinases. A phase I dose escalation study was conducted to determine the safety and pharmacokinetics of ASLAN-002 in patients with advanced cancer. Methods Patients with advanced or metastatic solid tumours, who had progressed on standard therapy or for whom standard therapy was not known, were administered ASLAN-002 orally...
May 16, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29765870/low-starting-dosage-of-infliximab-with-possible-escalating-dosage-in-psoriatic-arthritis-gives-the-same-treatment-results-as-standard-dosage-of-adalimumab-or-etanercept-results-from-the-nationwide-icelandic-icebio-registry
#20
Bjorn Gudbjornsson, Arni Jon Geirsson, Niels Steen Krogh
Objective: To explore differences in response to a low dosage regimen of infliximab with an escalating dosage in comparison to a standard dosage of etanercept and adalimumab in patients with psoriatic arthritis (PsA). Methods: Biologically naïve PsA patients who were beginning anti-TNF-α therapy were selected from the ICEBIO registry. Demographics and clinical differences were compared in four treatment groups: infliximab <4 mg/kg; infliximab >4 mg/kg; etanercept or adalimumab at baseline and on follow-up (6 and 12 months, last visit)...
2018: Psoriasis: targets and therapy
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