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Good Clinical Practices

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https://www.readbyqxmd.com/read/28544662/tracheal-replacement-therapy-with-a-stem-cell-seeded-graft-lessons-from-compassionate-use-application-of-a-gmp-compliant-tissue-engineered-medicine
#1
Martin J Elliott, Colin R Butler, Aikaterini Varanou-Jenkins, Leanne Partington, Carla Carvalho, Edward Samuel, Claire Crowley, Peggy Lange, Nicholas J Hamilton, Robert E Hynds, Tahera Ansari, Paul Sibbons, Anja Fierens, Claire McLaren, Derek Roebuck, Colin Wallis, Nagarajan Muthialu, Richard Hewitt, David Crabbe, Sam M Janes, Paolo De Coppi, Mark W Lowdell, Martin A Birchall
Tracheal replacement for the treatment of end-stage airway disease remains an elusive goal. The use of tissue-engineered tracheae in compassionate use cases suggests that such an approach is a viable option. Here, a stem cell-seeded, decellularized tissue-engineered tracheal graft was used on a compassionate basis for a girl with critical tracheal stenosis after conventional reconstructive techniques failed. The graft represents the first cell-seeded tracheal graft manufactured to full good manufacturing practice (GMP) standards...
June 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28544366/enumeration-of-wt1-specific-cd8-t-cells-for-clinical-application-using-an-mhc-streptamer-based-no-wash-single-platform-flow-cytometric-assay
#2
Sarah Matko, Madeleine Teichert, Antje Tunger, Marc Schmitz, Martin Bornhauser, Torsten Tonn, Marcus Odendahl
The advent of novel strategies to generate leukemia-associated-antigen (LAA)-specific T cells for adoptive immunotherapies creates a demand for standardized good laboratory practice (GLP)-compliant enumeration assays to provide a secure clinical environment-whether it is to identify potential donors, define therapeutic doses for transplantation, or monitor clinical success. Here, we introduce a no-wash assay based on single-platform cell enumeration and Streptamer staining to determine the Wilms' tumor antigen 1 (WT1)-specific T cell immunity in clinical samples...
May 25, 2017: Cytometry. Part A: the Journal of the International Society for Analytical Cytology
https://www.readbyqxmd.com/read/28543408/validation-and-cross-cultural-adaptation-of-the-arabic-version-of-the-nasal-obstruction-symptom-evaluation-scale
#3
Mohamed A Amer, Ibrahim A Kabbash, Ahmed A Yonis, Saad Elzayat, Mohamed O Tomoum
OBJECTIVES/HYPOTHESIS: Validation and cross-cultural adaptation of the Nasal Obstruction Symptom Evaluation (NOSE) scale into the Arabic language with studying of its psychometric properties. STUDY DESIGN: Prospective instrument-validation study. METHODS: Guidelines for the cross-cultural adaptation process from the original English language scale into the Arabic language version were followed. We assessed the psychometric properties of the Arabic version of the NOSE scale (A-NOSE) (feasibility, reproducibility, internal consistency, reliability, discriminatory validity, responsiveness to change) in 101 consecutive patients who underwent septal surgery (preoperatively and 3 months postoperatively) and 102 asymptomatic controls...
May 23, 2017: Laryngoscope
https://www.readbyqxmd.com/read/28542627/predictive-features-of-chronic-kidney-disease-in-atypical-haemolytic-uremic-syndrome
#4
Matthieu Jamme, Quentin Raimbourg, Dominique Chauveau, Amélie Seguin, Claire Presne, Pierre Perez, Pierre Gobert, Alain Wynckel, François Provôt, Yahsou Delmas, Christiane Mousson, Aude Servais, Laurence Vrigneaud, Agnès Veyradier, Eric Rondeau, Paul Coppo
Chronic kidney disease (CKD) is a frequent and serious complication of atypical haemolytic uremic syndrome (aHUS). We aimed to develop a simple accurate model to predict the risk of renal dysfunction in aHUS based on clinical and biological features available at hospital admission. Renal function at 1-year follow-up, based on an estimated glomerular filtration rate < 60mL/min/1.73m2 as assessed by the Modification of Diet in Renal Disease equation, was used as an indicator of significant CKD. Prospectively collected data from a cohort of 156 aHUS patients who did not receive eculizumab were used to identify predictors of CKD...
2017: PloS One
https://www.readbyqxmd.com/read/28541857/a-multidisciplinary-child-protection-team-improves-the-care-of-nonaccidental-trauma-patients
#5
John M Draus
We initiated a multidisciplinary Child Protection Team (CPT) as a subgroup of our pediatric multidisciplinary trauma peer review committee. Meetings are held monthly. Nonaccidental trauma (NAT) patients from the preceding month are reviewed. The meeting has two parts. During the open part, detectives and child protective services (CPS) workers are invited to discuss specific cases. The closed part focuses on improvement of specific processes and future outcomes. Attendance is recorded and minutes are kept. We sought to review accomplishments of this group...
May 1, 2017: American Surgeon
https://www.readbyqxmd.com/read/28540855/interest-of-the-combined-measurement-of-selected-urinary-proteins-in-the-diagnosis-approach-in-nephrology
#6
Jean-Philippe Bastard, Soraya Fellahi, François-Xavier Lescure, Jacqueline Capeau, Pierre Ronco, Emmanuelle Plaisier
Determination of the protein composition of urine is a non-invasive method helping to diagnose renal lesions and evaluate therapeutic interventions. We present here five observations that highlight the performance and relevance of urine protein analysis combining selected glomerular and tubular protein measurements. Total urine protein level and measurements of urinary IgG, albumin, transferrin alpha-1 microglobulin and retinol binding protein were performed on a urine sample by immunonephelometry. The results were normalized for urine creatinine concentration and integrated in the MDI interpretation software that provides a "urine protein profile" (UPP)...
June 1, 2017: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/28540594/recent-progress-in-virtual-reality-exposure-therapy-for-phobias-a-systematic-review
#7
REVIEW
Cristina Botella, Javier Fernández-Álvarez, Verónica Guillén, Azucena García-Palacios, Rosa Baños
This review is designed to systematically examine the available evidence about virtual reality exposure therapy's (VRET) efficacy for phobias, critically describe some of the most important challenges in the field and discuss possible directions. Evidence reveals that virtual reality (VR) is an effective treatment for phobias and useful for studying specific issues, such as pharmacological compounds and behavioral manipulations, that can enhance treatment outcomes. In addition, some variables, such as sense of presence in virtual environments, have a significant influence on outcomes, but further research is needed to better understand their role in therapeutic outcomes...
July 2017: Current Psychiatry Reports
https://www.readbyqxmd.com/read/28540437/volatile-organic-compounds-and-good-laboratory-practices-in-the-in-vitro-fertilization-laboratory-the-important-parameters-for-successful-outcome-in-extended-culture
#8
Nupur Agarwal, Ratna Chattopadhyay, Sanghamitra Ghosh, Arpita Bhoumik, S K Goswami, Baidyanath Chakravarty
PURPOSE: This study aims to describe the role of implementing good laboratory practices to improve in vitro fertilization (IVF) outcomes which are of great interest for practitioners dealing with infertility. METHODS: Certain modifications were introduced in May 2015 in our IVF laboratory like high-efficiency particulate air CODA system, steel furniture instead of wooden, use of new disinfectants like oosafe, and restriction of personnel entry along with avoidance of cosmetics like perfume to improve pregnancy rates...
May 24, 2017: Journal of Assisted Reproduction and Genetics
https://www.readbyqxmd.com/read/28540222/penile-fracture-epidemiology-diagnosis-and-management-in-iran-a-narrative-review
#9
REVIEW
Majid Mirzazadeh, Morteza Fallahkarkan, Jalil Hosseini
Penile fracture (PF) is considered an emergency in urology. In the literature there are some case series reporting considerable incidence of PF in some parts of Iran. There are no accurate data about the incidence of PF all around Iran. Although it may be uncommon in other parts of the country and in the other countries, it can also be underreported. There are some challenges in diagnosis, management, and also reporting of these cases. In this review of Iranian medical literature, we searched for penile fracture and penile injury keywords in Medline, Scopus, SID, Google and Persian medical journals...
April 2017: Translational Andrology and Urology
https://www.readbyqxmd.com/read/28540102/awareness-and-knowledge-of-undergraduate-dental-students-about-sterilization-disinfection-methods-of-extracted-human-teeth
#10
S C Deogade, S S Mantri, S Saxena, K Sumathi
BACKGROUND: Dental undergraduate students work on extracted human teeth in preclinical practical's to learn technical skills before entering the clinics and delivering dental care to the patients. AIM: The aim of the present investigation was to assess the awareness and knowledge toward sterilization/disinfection methods of extracted human teeth in a selected group of Indian dental students. MATERIALS AND METHODS: In this descriptive cross-sectional study, the participants consisted of 2(nd)-, 3(rd)-, 4(th)-, and 5(th)-year dental students...
November 2016: Annals of Medical and Health Sciences Research
https://www.readbyqxmd.com/read/28537808/dose-intense-dose-dense-and-tailored-dose-adjuvant-chemotherapy-for-early-breast-cancer-an-evolution-of-concepts
#11
Alexios Matikas, Theodoros Foukakis, Jonas Bergh
BACKGROUND: The introduction of adjuvant chemotherapy following surgery for early breast cancer (BC) and its integration into routine clinical practice has consistently improved clinical outcomes. Since the addition of other agents to the contemporary standard of care containing an anthracycline, cyclophosphamide and a taxane has not lead to further prolongation of survival, subsequent efforts concentrated on escalating the administered doses and reducing the time interval between chemotherapy cycles...
May 24, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28537324/validation-of-the-photography-method-for-nutritional-intake-assessment-in-hospitalized-elderly-subjects
#12
F Monacelli, M Sartini, V Bassoli, D Becchetti, A L Biagini, A Nencioni, M Cea, R Borghi, F Torre, P Odetti
OBJECTIVE: The aim of the present study was to validate the photographic indirect method as an accurate and specific tool to assess nutritional intake in a cohort of elderly hospitalized patients. DESIGN: this is a prospective observational study. SETTING: hospital (geriatric acute ward and transitional care of IRCCSS AUO San Martino Hospital, Genoa, Italy). PARTICIPANTS: 255 consecutive elderly hospitalized patients...
2017: Journal of Nutrition, Health & Aging
https://www.readbyqxmd.com/read/28537222/the-revision-of-the-ich-good-clinical-practice-guidelines-a-missed-opportunity
#13
Raffaella Ravinetto
The Guideline for Good Clinical Practice (GCP) of the International Conference of Harmonisation (ICH) is an international standard for the ethical and scientific quality of the designing, conducting, recording and reporting of trials that involve the participation of human subjects. Today, most regulators and funding agencies follow the ICH guidelines. These were drawn up by a small number of regulatory agencies and drug companies from high-income countries and do not pay sufficient heed to the problematic aspects of clinical trials in the low- and middle-income countries...
May 23, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28536731/a-novel-actinic-keratosis-field-assessment-scale-for-grading-actinic-keratosis-disease-severity
#14
Brigitte Dréno, Rino Cerio, Thomas Dirschka, Ignasi Figueras Nart, John T Lear, Ketty Peris, Andrés Ruiz de Casas, Kaleci Shaniko, Giovanni Pellacani
Actinic keratosis (AK) lesions are surrounded by field cancerization (areas of subclinical, non-visible sun damage). Existing AK grading tools rely on AK counts, which are not reproducible. An Actinic Keratosis Field Assessment Scale (AK-FAS) for grading the severity of AK/field was developed. Standardized photographs of patients representing the full range of AK severity were collected. Six investigators independently rated each photograph according to 3 criteria: AK area (total skin area affected by AK lesions), hyperkeratosis and sun damage...
May 24, 2017: Acta Dermato-venereologica
https://www.readbyqxmd.com/read/28536104/development-and-validation-of-qrisk3-risk-prediction-algorithms-to-estimate-future-risk-of-cardiovascular-disease-prospective-cohort-study
#15
Julia Hippisley-Cox, Carol Coupland, Peter Brindle
Objectives To develop and validate updated QRISK3 prediction algorithms to estimate the 10 year risk of cardiovascular disease in women and men accounting for potential new risk factors.Design Prospective open cohort study.Setting General practices in England providing data for the QResearch database.Participants 1309 QResearch general practices in England: 981 practices were used to develop the scores and a separate set of 328 practices were used to validate the scores. 7.89 million patients aged 25-84 years were in the derivation cohort and 2...
May 23, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28534606/standardized-reporting-of-functioning-information-on-icf-based-common-metrics
#16
Birgit Prodinger, Alan Tennant, Gerold Stucki
BACKGROUND: In clinical practice and research a variety of clinical data collection tools are used to collect information on people's functioning for clinical practise and research and National Health Information Systems. Reporting on ICF-based common metrics enables standardized documentation of functioning information in national health information systems. OBJECTIVE: The objective of this methodological note on applying the ICF in rehabilitation is to demonstrate how to report functioning information collected with a data collection tool on ICF-based common metrics...
May 23, 2017: European Journal of Physical and Rehabilitation Medicine
https://www.readbyqxmd.com/read/28534335/-consistency-analysis-between-preoperative-ct-enterography-and-intraoperative-findings-in-patients-undergoing-surgery-for-crohn-s-disease
#17
Jianbo Yang, Jianfeng Gong, Yi Li, Lili Gu, Weiming Zhu, Jieshou Li
OBJECTIVE: To evaluate the diagnostic value of preoperative CT enterography (CTE) on obstruction, fistula and abscess formation compared to intraoperative findings in patients undergoing surgery for Crohn's disease(CD), aiming to provide reference to clinical practice. METHODS: Preoperative CTE data of 176 CD patients confirmed by clinic, endoscopy, imaging, operation and pathology at the Department of General Surgery in Nanjing Jinling Hospital from January 2013 to December 2015 were enrolled in retrospective cohort study...
May 25, 2017: Zhonghua Wei Chang Wai Ke za Zhi, Chinese Journal of Gastrointestinal Surgery
https://www.readbyqxmd.com/read/28534248/immune-checkpoint-inhibitor-therapy-what-line-of-therapy-and-how-to-choose
#18
REVIEW
Chethan Ramamurthy, James L Godwin, Hossein Borghaei
Immunotherapy is now an established part of the treatment paradigm for advanced non-small cell lung cancer (NSCLC), but the line of therapy and the sequence of agents are still in flux. In this time when much is to be learned, the optimal therapy for most patients in both the first-line and previously treated settings is in the context of a clinical trial. For standard therapy, however, there are good data to support the practice of programmed death-ligand 1 (PD-L1) testing in the front-line advanced setting and to use pembrolizumab as first-line therapy for those with ≥50% PD-L1 expression...
June 2017: Current Treatment Options in Oncology
https://www.readbyqxmd.com/read/28533935/a-review-of-the-emerging-potential-therapy-for-neurological-disorders-human-embryonic-stem-cell-therapy
#19
REVIEW
Geeta Shroff, Jyoti Dhanda Titus, Rhea Shroff
The first human embryonic stem cell (hESC) line was developed in the late nineties. hESCs are capable of proliferating indefinitely and differentiate into all the three embryonic germ layers. Further, the differentiation of hESC lines into neural precursor cells and neurons, astrocytes and oligodendrocytes showed their potential in treating several incurable neurological disorders such as spinal cord injury (SCI), cerebral palsy (CP), Parkinson's disease (PD). In this review, we will discuss the global scenario of research and therapeutic use of hESCs in the treatment of neurological disorders...
2017: American Journal of Stem Cells
https://www.readbyqxmd.com/read/28532985/upper-limb-and-hand-patterns-in-cerebral-palsy-reliability-of-two-new-classifications
#20
E Chaleat-Valayer, R Bard-Pondarre, J C Bernard, F Roumenoff, A Lucet, A Denis, P Occelli, S Touzet
AIM: To evaluate the inter- and intra-rater reliability of two previously developed classifications of upper limb and hand patterns. METHOD: Two hundred and twelve films of patients with CP (118 of UL postures and 94 of hand tasks; median age 14, 3-46 years) were viewed by 18 examiners from 2 different rehabilitation centers, and one expert who had participated in the design of the classifications. They classed upper limb (3 patterns with sub-types) and hand patterns (2 patterns with subtypes) twice, at 2 months' interval...
May 10, 2017: European Journal of Paediatric Neurology: EJPN
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