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Clinical development

Claudia Schadow, Hanna Schmidt, Alexander Schorcht, Frank Meyer
MEDICAL HISTORY AND CLINICAL FINDINGS:  A 43-year old male patient was admitted because of diffuse abdominal discomfort for two days, which had started in the upper abdomen; medical history, no previous surgical interventions at the abdomen. INVESTIGATIONS:  Gastroscopy and abdominal ultrasound revealed only a mild gastritis. Laboratory parameters: showed only a slight leucocytosis (10 610/µL). On the 1st day of the hospital stay, the patient developed a worsening of the abdominal symptoms with distended abdomen, sounding bowel movements and recurrent vomiting, which were interpreted as acute abdomen by the surgeon on call leading to the indication of a surgical intervention...
March 2018: Deutsche Medizinische Wochenschrift
Christina Schumann, Michael Faust
BACKGROUND:  Diabetic ketoacidosis and the hyperosmolar hyperglycemic state are the most serious diabetic emergencies. Before the discovery of insulin in 1921 by Banting and Best the diagnosis of type 1 diabetes was fatal ending in diabetic ketoacidosis equivalent to a torturous death. Today, mortality from diabetic ketoacidosis is low at approximately 2 %. But each death from these two acute metabolic complications of diabetes is potentially avoidable by improved patient and healthcare professional education...
March 2018: Deutsche Medizinische Wochenschrift
Daniel Deimel
Clinical social work has established itself as a health-specific profession in Germany over the past 15 years. It refers to a bio-psycho-social health understanding and is particularly focused on hard-to-reach client groups. The concept of evidence-based practice is often criticized and rejected by parts of the profession and discipline of social work. The concepts of evidence-based medicine and clinical social work are associated with positive outcomes for clinical practice and professional development.
March 15, 2018: Das Gesundheitswesen
Evelina Cardoso, Thomas Mercier, Anna Dorothea Wagner, Krisztian Homicsko, Olivier Michielin, Kim Ellefsen-Lavoie, Laurène Cagnon, Manuel Diezi, Thierry Buclin, Nicolas Widmer, Chantal Csajka, Laurent Decosterd
A sensitive and selective method of high performance liquid chromatography (HPLC) coupled to tandem mass spectrometry (MS/MS) has been developed for the simultaneous quantification of six anticancer protein kinase inhibitors (PKIs), dabrafenib, trametinib, vemurafenib, cobimetinib, pazopanib, regorafenib, and two active metabolites (regorafenib-M2 and regorafenib-M5) in human plasma. Plasma protein precipitation with methanol enables the sample extraction of 100 μL aliquot of plasma. Analytes are detected by electrospray triple-stage quadrupole mass spectrometry and quantified using the calibration curves with stable isotope-labeled internal standards...
February 8, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Wei Tse Li, Hao Zheng, Vincent Nguyen, Jessica Wang-Rodriguez, Weg M Ongkeko
Though bladder urothelial carcinoma is the most common form of bladder cancer, advances in its diagnosis and treatment have been modest in the past few decades. To evaluate miRNAs as putative disease markers for bladder urothelial carcinoma, this study develops a process to identify dysregulated miRNAs in cancer patients and potentially stratify patients based on the association of their microRNAome phenotype to genomic alterations. Using RNA sequencing data for 409 patients from the Cancer Genome Atlas, we examined miRNA differential expression between cancer and normal tissues and associated differentially expressed miRNAs with patient survival and clinical variables...
March 12, 2018: Neoplasia: An International Journal for Oncology Research
Angus Fayia Tengbeh, Luisa Enria, Elizabeth Smout, Thomas Mooney, Mike Callaghan, David Ishola, Bailah Leigh, Deborah Watson-Jones, Brian Greenwood, Heidi Larson, Shelley Lees
The 2014-2016 Ebola epidemic presented a challenging setting in which to carry out clinical trials. This paper reports findings from social science research carried out in Kambia, Northern Sierra Leone during first year of an Ebola vaccine trial (August 2015-July 2016). The social science team collected data through ethnographic observation, 42 in depth interviews; 4 life narratives; 200 exit interviews; 31 key informant interviews; and 8 focus group discussions with trial participants and community members not enrolled in the trial...
March 5, 2018: Social Science & Medicine
Amanda N Seddon, Joshua Chaim, Oguz Akin, Esther Drill, Angela G Michael, Nelly Adel, Martin S Tallman
BACKGROUND: The current standard of care for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) is an anthracycline plus cytarabine. Both anthracyclines and cytarabine have been associated with the development of typhlitis, a serious adverse event characterized by inflammation of the bowel wall in patients with profound neutropenia, diagnosed by abdominal CT imaging and clinical symptoms. Given the paucity of available data, the aim of our study was to determine the incidence of typhlitis among AML patients receiving induction chemotherapy with idarubicin 12 mg/m2 (IDA), daunorubicin 60 mg/m2 (DNA60), or daunorubicin 90 mg/m2 (DNA90)...
March 8, 2018: Leukemia Research
Vesa M Olkkonen, Juha Sinisalo, Matti Jauhiainen
Remarkably good results have been achieved in the treatment of atherosclerotic cardiovascular diseases (CVD) by using statin, ezetimibe, antihypertensive, antithrombotic, and PCSK9 inhibitor therapies and their proper combinations. However, despite this success, the remaining CVD risk is still high. To target this residual risk and to treat patients who are statin-intolerant or have an exceptionally high CVD risk for instance due to familial hypercholesterolemia (FH), new therapies are intensively sought. One pathway of drug development is targeting the circulating triglyceride-rich lipoproteins (TRL) and their lipolytic remnants, which, according to the current view, confer a major CVD risk...
March 8, 2018: Atherosclerosis
Urmi Bajpai, Abhishek Kumar Mehta, Kandasamy Eniyan, Avni Sinha, Ankita Ray, Simran Virdi, Shazeb Ahmad, Aridni Shah, Deepanksha Arora, Devyani Marwaha, Gunjan Chauhan, Prarthna Saraswat, Punita Bathla, Ruchi Singh
Bacteriophages are being considered as a promising natural resource for the development of alternative strategies against mycobacterial diseases, especially in the context of the wide spread occurrence of drug-resistance amongst the clinical isolates of M. tuberculosis. However, there isn't much information documented on mycobacteriophages from India. Here, we report the isolation of 17 mycobacteriophages using M. smegmatis as the bacterial host where 9 phages also lyse M. tuberculosis H37Rv. We present detailed analysis of one of these mycobacteriophage (PDRPv)...
March 15, 2018: Canadian Journal of Microbiology
Brenda Si Elias, Ana Hanlon-Dearman, Betty Head, Geoffrey G Hicks
Translating to the Community (T2C) is a social bio-repository designed to advance new diagnostic tools and realign community-clinical processes, with the aim to mitigate the short-and-long term impacts of Fetal Alcohol Spectrum Disorder (FASD), prenatal alcohol exposure, and its co-morbidities and behaviors. In this paper, we describe the evolution of this repository as a new translational partnership to advance a precision medicine approach to FASD. Key to its evolution was a partnership between academic researchers, Indigenous communities, families and a regional diagnostic clinic...
March 15, 2018: Biochemistry and Cell Biology, Biochimie et Biologie Cellulaire
Emily A McCourt, Gui-Shuang Ying, Anne M Lynch, Alan G Palestine, Brandie D Wagner, Erica Wymore, Lauren A Tomlinson, Gil Binenbaum
Importance: The Colorado Retinopathy of Prematurity (CO-ROP) model uses birth weight, gestational age, and weight gain at the first month of life (WG-28) to predict risk of severe retinopathy of prematurity (ROP). In previous validation studies, the model performed very well, predicting virtually all cases of severe ROP and potentially reducing the number of infants who need ROP examinations, warranting validation in a larger, more diverse population. Objective: To validate the performance of the CO-ROP model in a large multicenter cohort...
March 15, 2018: JAMA Ophthalmology
Carmen Scheibenbogen, Madlen Loebel, Helma Freitag, Anne Krueger, Sandra Bauer, Michaela Antelmann, Wolfram Doehner, Nadja Scherbakov, Harald Heidecke, Petra Reinke, Hans-Dieter Volk, Patricia Grabowski
INTRODUCTION: Infection-triggered disease onset, chronic immune activation and autonomic dysregulation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) point to an autoimmune disease directed against neurotransmitter receptors. We had observed elevated autoantibodies against ß2 adrenergic receptors, and muscarinic 3 and 4 acetylcholine receptors in a subset of patients. Immunoadsorption (IA) was shown to be effective in removing autoantibodies and improve outcome in various autoimmune diseases...
2018: PloS One
Frank Niemeyer, Lutz Claes, Anita Ignatius, Nicholaus Meyers, Ulrich Simon
Distraction osteogenesis is an effective method for generating large amounts of bone in situ for treating pathologies such as large bone defects or skeletal malformations, for instance leg-length discrepancies. While an optimized distraction procedure might have the potential to reduce the rate of complications significantly, our knowledge of the underlying mechanobiological processes is still insufficient for systematic optimization of treatment parameters such as distraction rate or fixation stiffness. We present a novel numerical model of lateral distraction osteogenesis, based on a mechanically well-controlled in vivo experiment...
2018: PloS One
Wendy A Davis, David G Bruce, Milan Dragovic, Timothy M E Davis, Sergio E Starkstein
BACKGROUND: Previous research using latent class analysis (LCA) identified classes of people with type 2 diabetes and specific profiles of depression and anxiety. Since LCA-derived anxious depression strongly predicts cardiovascular outcomes and mortality but cannot be applied to individuals, we developed a validated combined depression-anxiety metric, the Diabetes Anxiety Depression Scale (DADS), for potential clinical application in people with type 2 diabetes. METHODS: 1,337 participants with type 2 diabetes from the observational community-based Fremantle Diabetes Study Phase II completed the Patient Health Questionnaire 9-item version (PHQ-9) to assess symptoms of depression, and the Generalised Anxiety Disorder Scale (GADS) to assess symptoms of anxiety...
2018: PloS One
Lisa Blom, Lucie Laflamme, Helle Mölsted Alvesson
BACKGROUND: Image-based teleconsultation between medical experts and healthcare staff at remote emergency centres can improve the diagnosis of conditions which are challenging to assess. One such condition is burns. Knowledge is scarce regarding how medical experts perceive the influence of such teleconsultation on their roles and relations to colleagues at point of care. METHODS: In this qualitative study, semi-structured interviews were conducted with 15 medical experts to explore their expectations of a newly developed App for burns diagnostics and care prior to its implementation...
2018: PloS One
I-Ting Kuo, Kuang-Yi Chang, De-Fong Juan, Steen J Hsu, Chia-Tai Chan, Mei-Yung Tsou
Pain relief always plays the essential part of perioperative care and an important role of medical quality improvement. Patient-controlled analgesia (PCA) is a method that allows a patient to self-administer small boluses of analgesic to relieve the subjective pain. PCA logs from the infusion pump consisted of a lot of text messages which record all events during the therapies. The dosage information can be extracted from PCA logs to provide easily understanding features. The analysis of dosage information with time has great help to figure out the variance of a patient's pain relief condition...
2018: PloS One
Vincent Plagnol, Samuel Woodhouse, Karen Howarth, Stefanie Lensing, Matt Smith, Michael Epstein, Mikidache Madi, Sarah Smalley, Catherine Leroy, Jonathan Hinton, Frank de Kievit, Esther Musgrave-Brown, Colin Herd, Katherine Baker-Neblett, Will Brennan, Peter Dimitrov, Nathan Campbell, Clive Morris, Nitzan Rosenfeld, James Clark, Davina Gale, Jamie Platt, John Calaway, Greg Jones, Tim Forshew
Circulating tumor DNA (ctDNA) analysis is being incorporated into cancer care; notably in profiling patients to guide treatment decisions. Responses to targeted therapies have been observed in patients with actionable mutations detected in plasma DNA at variant allele fractions (VAFs) below 0.5%. Highly sensitive methods are therefore required for optimal clinical use. To enable objective assessment of assay performance, detailed analytical validation is required. We developed the InVisionFirst™ assay, an assay based on enhanced tagged amplicon sequencing (eTAm-Seq™) technology to profile 36 genes commonly mutated in non-small cell lung cancer (NSCLC) and other cancer types for actionable genomic alterations in cell-free DNA...
2018: PloS One
Fernando Yepes-Calderon, Marvin D Nelson, J Gordon McComb
The picture archiving and communications system (PACS) is currently the standard platform to manage medical images but lacks analytical capabilities. Staying within PACS, the authors have developed an automatic method to retrieve the medical data and access it at a voxel level, decrypted and uncompressed that allows analytical capabilities while not perturbing the system's daily operation. Additionally, the strategy is secure and vendor independent. Cerebral ventricular volume is important for the diagnosis and treatment of many neurological disorders...
2018: PloS One
Vanesa Alende-Castro, Cristina Macía-Rodríguez, Ignacio Novo-Veleiro, Xana García-Fernández, Mercedes Treviño-Castellano, Sergio Rodríguez-Fernández, Arturo González-Quintela
BACKGROUND: Forms of presentation of Q fever vary widely across Spain, with differences between the north and south. In the absence of reported case series from Galicia (north-west Spain), this study sought to describe a Q-fever case series in this region for the first time, and conduct a systematic review to analyse all available data on the disease in Spain. METHODS: Patients with positive serum antibodies to Coxiella burnetii from a single institution over a 5-year period (January 2011-December 2015) were included...
March 15, 2018: PLoS Neglected Tropical Diseases
Andrea Cristine Koishi, Andréia Akemi Suzukawa, Camila Zanluca, Daria Elena Camacho, Guillermo Comach, Claudia Nunes Duarte Dos Santos
Zika virus (ZIKV) is an emerging arbovirus belonging to the genus flavivirus that comprises other important public health viruses, such as dengue (DENV) and yellow fever (YFV). In general, ZIKV infection is a self-limiting disease, however cases of Guillain-Barré syndrome and congenital brain abnormalities in newborn infants have been reported. Diagnosing ZIKV infection remains a challenge, as viral RNA detection is only applicable until a few days after the onset of symptoms. After that, serological tests must be applied, and, as expected, high cross-reactivity between ZIKV and other flavivirus serology is observed...
March 15, 2018: PLoS Neglected Tropical Diseases
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