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https://www.readbyqxmd.com/read/28211195/a-comparison-of-the-new-japanese-expedited-approval-legislation-for-regenerative-medicine-product-with-the-existing-systems-of-the-united-states-and-european-union
#1
Yoji Jokura, Kazuo Yano, Masayuki Yamato
Expedited approval pathways/programs for drugs, biologics, or medical devices have been enacted for rapid product commercialization of innovative products in the United States (US) and European Union (EU). However, less innovative products are increasingly using these expedited pathways and frequently obligations to collect and report post-marketing data on approved products are being bypassed. The Japanese government recently enacted a new conditional and time-limited approval pathway dedicated to regenerative medicine products...
February 17, 2017: Journal of Tissue Engineering and Regenerative Medicine
https://www.readbyqxmd.com/read/28169302/precision-medicine-needs-randomized-clinical-trials
#2
REVIEW
Everardo D Saad, Xavier Paoletti, Tomasz Burzykowski, Marc Buyse
The advent of precision medicine has prompted profound changes in clinical cancer research, and the rising numbers of new therapeutic agents pose challenges in terms of the most appropriate trial designs and effects on the drug-approval process. In the past 5 years, some remarkably efficacious drugs have been approved based on evidence from uncontrolled phase I trials. We challenge the view that the expected benefits from new drugs are generally sufficient to forgo a randomized trial with patients assigned to a control arm (a regimen other than the experimental treatment)...
February 7, 2017: Nature Reviews. Clinical Oncology
https://www.readbyqxmd.com/read/28165177/intrauterine-death-rate-in-gastroschisis-following-the-introduction-of-an-antenatal-surveillance-program-retrospective-observational-study
#3
Helen Perry, Costa Healy, Diana Wellesley, Nigel J Hall, Melanie Drewett, David M Burge, David T Howe
AIM: To investigate whether an antenatal surveillance protocol including ultrasound and cardiotocograph monitoring reduces intrauterine death (IUD) in cases of gastroschisis. Secondary outcomes included neonatal death rate, mode of delivery and rate of intervention before planned time of delivery. METHODS: This was a retrospective observational study of all women with antenatally diagnosed gastroschisis who were managed according to the surveillance program between 2002 and 2015 in a tertiary fetal medicine and pediatric surgical center covering the Wessex region of England...
February 6, 2017: Journal of Obstetrics and Gynaecology Research
https://www.readbyqxmd.com/read/28155078/the-promise-of-molecular-imaging-in-the-study-and-treatment-of-infectious-diseases
#4
Sanjay K Jain
Infectious diseases are a major threat to humanity, and it is imperative that we develop imaging tools that aid in their study, facilitate diagnosis, and guide treatment. The alarming rise of highly virulent and multi-drug-resistant pathogens, their rapid spread leading to frequent global pandemics, fears of bioterrorism, and continued life-threatening nosocomial infections in hospitals remain as major challenges to health care in the USA and worldwide. Early diagnosis and rapid monitoring are essential for appropriate management and control of infections...
February 2, 2017: Molecular Imaging and Biology: MIB: the Official Publication of the Academy of Molecular Imaging
https://www.readbyqxmd.com/read/28061634/personalized-medicine-approach-for-an-exceptional-response-to-multiple-recurrent-and-metastatic-her2-positive-oropharyngeal-squamous-cell-carcinoma
#5
Nolan B Seim, Stephen Y Kang, Milan Bhandari, Riley G Jones, Theodoros N Teknos
INTRODUCTION: Advanced stage squamous cell carcinoma of the head and neck carries an overall poor prognosis, and survivorship gains have remained relatively stagnant compared to other malignancies due to its complex tumor biology and lack of proven effective targeting agents. METHODS: We present a case of an exceptional responder to molecular-targeted therapy for metastatic oropharyngeal squamous cell carcinoma using a chemotherapeutic agent FDA approved for breast cancer and targeting the HER2/Neu receptor in order to discuss the larger clinical implications...
January 1, 2017: Annals of Otology, Rhinology, and Laryngology
https://www.readbyqxmd.com/read/28057368/genomic-translational-research-paving-the-way-to-individualized-cardiac-functional-analyses-and-personalized-cardiology
#6
REVIEW
Ares Pasipoularides
For most of Medicine's past, the best that physicians could do to cope with disease prevention and treatment was based on the expected response of an average patient. Currently, however, a more personalized/precise approach to cardiology and medicine in general is becoming possible, as the cost of sequencing a human genome has declined substantially. As a result, we are witnessing an era of precipitous advances in biomedicine and bourgeoning understanding of the genetic basis of cardiovascular and other diseases, reminiscent of the resurgence of innovations in physico-mathematical sciences and biology-anatomy-cardiology in the Renaissance, a parallel time of radical change and reformation of medical knowledge, education and practice...
March 1, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28056571/compounds-compositions-and-methods-of-agelastatin-alkaloids-patent-evaluation-of-wo2015042239-a1
#7
Takehiko Yoshimitsu, Han W Tun
Agelastatins are a family of tetracyclic alkaloids isolated from marine sponges. The patent examined in this publication covers the chemical synthesis of agelastatins A to F and eight analogues and their therapeutic use against hematologic malignancies. The claim on the chemical synthesis features a novel biomimetic cyclization of a tricyclic precursor, which streamlines scalable access to agelastatins and their analogues. This new synthetic approach can potentially expedite the research on these compounds for therapeutic use against cancers by making them more easily available...
January 5, 2017: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/28029082/probiotics-in-curing-allergic-and-inflammatory-conditions-research-progress-and-futuristic-vision
#8
Kuldeep Dhama, Shyma K Latheef, Ashok Kumar Munjal, Rekha Khandia, Hari Abdul Samad, Hafiz M N Iqbal, Sunil K Joshi
BACKGROUND: Probiotics constitute the viable and beneficial microbes, which offer a dietary means to sustain the balance of gastro-intestinal (GI) microflora. Owing to their multiple health benefits, these have recently gained wide attention among researchers for exploring their potential in safeguarding the health of humans and animals. Probiotics could also modulate host-immune responses, thereby help in counteracting the immunological dysfunctions. Probiotics can inhibit the systemic invasion of pathogens entering through the GI mucosa/ oral cavity and have been found to possess effective prophylactic and therapeutic utilities against various infectious pathogens as well as non-infectious diseases and disorders...
December 26, 2016: Recent Patents on Inflammation & Allergy Drug Discovery
https://www.readbyqxmd.com/read/27986708/blastic-plasmacytoid-dendritic-cell-neoplasm-is-dependent-on-bcl2-and-sensitive-to-venetoclax
#9
Joan Montero, Jason Stephansky, Tianyu Cai, Gabriel K Griffin, Lucia Cabal-Hierro, Katsuhiro Togami, Leah J Hogdal, Ilene Galinsky, Elizabeth A Morgan, Jon C Aster, Matthew S Davids, Nicole R LeBoeuf, Richard M Stone, Marina Konopleva, Naveen Pemmaraju, Anthony Letai, Andrew A Lane
: Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is an aggressive hematologic malignancy with dismal outcomes for which no standard therapy exists. We found that primary BPDCN cells were dependent on the antiapoptotic protein BCL2 and were uniformly sensitive to the BCL2 inhibitor venetoclax, as measured by direct cytotoxicity, apoptosis assays, and dynamic BH3 profiling. Animals bearing BPDCN patient-derived xenografts had disease responses and improved survival after venetoclax treatment in vivo Finally, we report on 2 patients with relapsed/refractory BPDCN who received venetoclax off-label and experienced significant disease responses...
February 2017: Cancer Discovery
https://www.readbyqxmd.com/read/27869877/-computerized-decision-support-systems-ebm-at-the-bedside
#10
Matteo Capobussi, Rita Banzi, Lorenzo Moja, Stefanos Bonovas, Marien González-Lorenzo, Elisa Giulia Liberati, Hernan Polo Friz, Oriana Nanni, Massimo Mangia, Francesca Ruggiero
INTRODUCTION: One of the aims of Evidence-Based Medicine is to improve quality and appropriateness of care by the expedition of the knowledge transfer process. Computerized Decision Support Systems (CDSSs) are computer programs that provide alerts to the prescribing doctor directly at the moment of medical examination. In fact, alerts are integrated within the single patient electronic health record. CDSS based on the best available and updated evidence and guidelines may be an efficient tool to facilitate the transfer of the latest results from clinical research directly at the bedside, thus supporting decision-making...
November 2016: Recenti Progressi in Medicina
https://www.readbyqxmd.com/read/27834522/principles-for-discharging-patients-from-acute-care-a-scoping-review-of-policy
#11
REVIEW
Liz Lees-Deutsch, Janelle Yorke, Ann-Louise Caress
BACKGROUND: Acute medicine units (AMUs) are part of acute hospital care, where length of patient stay is short and turnover is high. Expediting patient discharge safely is a major function of AMUs, which need up-to-date bespoke guidance. AIM: To carry out a scoping review of UK discharge policy to critically consider, compare and contrast the relevant discharge policies and guidance that underpin the assessment of acute patient discharge. OBJECTIVES: To inform the production of bespoke patient discharge guidance for AMUs...
November 10, 2016: British Journal of Nursing: BJN
https://www.readbyqxmd.com/read/27819246/21st-century-pharmacovigilance-efforts-roles-and-responsibilities
#12
REVIEW
Peter J Pitts, Hervé Le Louet, Yola Moride, Rena M Conti
In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27802559/faculty-development-directed-at-curricular-reforms-designed-to-improve-patient-outcomes
#13
Frank J Papa, Darrin D'Agostino
Three initiatives involving quality of patient outcomes that evolved in the late 1990s must be considered in the design of 21st century undergraduate medical curricula. They involve (1) the question of how to best teach and assess medical competencies, (2) growing concerns regarding the frequency and severity of error in medical care, and (3) the role physicians might play in weaving together the overlapping elements of population-, community-, and systems-based practice into a codified approach to medical care...
November 1, 2016: Journal of the American Osteopathic Association
https://www.readbyqxmd.com/read/27802026/magnetic-microbead-affinity-selection-screening-magmass-of-botanical-extracts-for-inhibitors-of-15-lipoxygenase
#14
Michael D Rush, Elisabeth M Walker, Tristesse Burton, Richard B van Breemen
To expedite the identification of active natural products in complex mixtures such as botanical extracts, a magnetic microbead affinity selection screening (MagMASS) procedure was developed. This technique utilizes target proteins immobilized on magnetic beads for rapid bioaffinity isolation of ligands from complex mixtures. A MagMASS method was developed and validated for 15-lipoxygenase. As a proof of concept, several North American prairie plants used medicinally by Native Americans were extracted with MeOH and screened...
November 23, 2016: Journal of Natural Products
https://www.readbyqxmd.com/read/27794541/military-officers-tropical-medicine-and-racial-thought-in-the-formation-of-the-west-india-regiments-1793-1802
#15
Michael Joseph
The article examines the establishment and growth between 1793 and 1802 of the West India Regiments, British army corps manned by slaves of African descent and commanded by European officers. Focusing on the medical history of British military operations in the West Indies, the article demonstrates that the rationale behind the regiments was medical, but that the impetus for them came from senior military commanders rather than from the medical practitioners whose writings are usually privileged in the historiography...
October 28, 2016: Journal of the History of Medicine and Allied Sciences
https://www.readbyqxmd.com/read/27769084/pulmonary-embolism-response-teams
#16
Alison S Witkin, Savanah Harshbarger, Christopher Kabrhel
Pulmonary embolism is a common and often life-threatening event. Treatment options include anticoagulation alone, catheter-directed therapies, and surgical thromboembolectomy. While guidelines exist, there is often controversy over which treatment is most appropriate, particularly for intermediate-risk patients. The traditional care model, in which the primary team is responsible for consulting the appropriate specialists, may be inadequate and inefficient for emergent situations, as ensuring coordination and communication between various consulting services can be a time consuming and confusing process...
November 2016: Seminars in Thrombosis and Hemostasis
https://www.readbyqxmd.com/read/27757206/efficacy-of-alum-for-treatment-of-recurrent-aphthous-stomatitis
#17
Nasrin Rafieian, Hamidreza Abdolsamadi, Aliakbar Moghadamnia, Mina Jazayeri, Mohammadali Seif-Rabiee, Mina Salmanzadeh, Shahrbanoo Radi
BACKGROUND: Recurrent aphthous stomatitis (RAS) is the most common painful ulcers of oral mucosal which can cause many sufferings. Treatment of RAS often includes administration of corticosteroids, analgesics and regulators of the immune system. However, considering the side effects of these medications, even their topical application must be done with caution. Alum is used in traditional medicine for treatment of oral ulcers without significant side effect. This study sought to assess the effect of topical application of alum on aphthous ulcers...
2016: Caspian Journal of Internal Medicine
https://www.readbyqxmd.com/read/27756354/use-of-point-of-care-testing-and-early-assessment-model-reduces-length-of-stay-for-ambulatory-patients-in-an-emergency-department
#18
Meri Kankaanpää, Maria Raitakari, Leila Muukkonen, Siv Gustafsson, Merja Heitto, Ari Palomäki, Kimmo Suojanen, Veli-Pekka Harjola
BACKGROUND: To assess whether the use of point-of-care testing (POCT) and early assessment team (EAT) model shortens emergency department (ED) length of stay (LOS). METHODS: This prospective, observational study with comparison between three study periods was performed in three phases in a metropolitan ED with 57,000 annual visits. Data were collected from adult ambulatory patients who were discharged home. Phase 1 served as a control (n = 1559 in one month)...
October 18, 2016: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
https://www.readbyqxmd.com/read/27749798/physician-adherence-to-centers-for-disease-control-and-prevention-guidelines-for-sexually-active-adolescents-in-the-pediatric-emergency-setting
#19
Michelle L Pickett, Marlene D Melzer-Lange, Melissa K Miller, Seema Menon, Alexis M Vistocky, Amy L Drendel
OBJECTIVES: There is limited literature about physicians' adherence to 2010 Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases Treatment Guidelines specific to specimen collection testing methods in adolescent females in the emergency setting is limited. The objectives are to (1) determine physician adherence to CDC guidelines for specimen collection/testing for chlamydia and gonorrhea, (2) determine physician characteristics associated with guideline adherence, and (3) describe physicians' knowledge of expedited partner therapy (EPT) laws...
October 4, 2016: Pediatric Emergency Care
https://www.readbyqxmd.com/read/27746703/extracting-pico-sentences-from-clinical-trial-reports-using-supervised-distant-supervision
#20
Byron C Wallace, Joël Kuiper, Aakash Sharma, Mingxi Brian Zhu, Iain J Marshall
Systematic reviews underpin Evidence Based Medicine (EBM) by addressing precise clinical questions via comprehensive synthesis of all relevant published evidence. Authors of systematic reviews typically define a Population/Problem, Intervention, Comparator, and Outcome (a PICO criteria) of interest, and then retrieve, appraise and synthesize results from all reports of clinical trials that meet these criteria. Identifying PICO elements in the full-texts of trial reports is thus a critical yet time-consuming step in the systematic review process...
2016: Journal of Machine Learning Research: JMLR
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