The concept of General Consent in Switzerland and the implementation at the University Hospital Zurich, a cross-sectional study

BACKGROUND: General Consent (GC) allows the further use of health-related data/samples for multiple, unspecified research projects and/or for the collection in databases and biobanks in Switzerland. The application of General Consent in the context of human research is regulated within the scope of the Human Research Act. At the University Hospital Zurich patients are informed about General Consent to which they can agree (GC = yes) or disagree (GC = no) to the use of their routinely collected data/samples in research. In this paper, we investigated the association of demographic and medical factors on a patient’s General Consent choice. METHODS: In this cross-sectional study, we investigated the association of age, gender, number of visits and number of diagnoses on General Consent choice. The study population was stratified by General Consent status group (GC choice: Yes, No, Not issued) and examined by means of descriptive statistics, comparative statistics and a multinomial and logistic regression model. A p-value of 0.001 was determined as significant. RESULTS: The female gender was found to associate with decreased odds in positive General Consent choice (<0.001) whereas age (<0.001) and number of diagnoses (<0.001) were associated with increased odds in positive General Consent choice (reference “GC = no” group). The number of visits (<0.001) as well as the number of diagnoses associated (<0.001) with increased General Consent collection (increase in positive as well as negative General Consent status). CONCLUSION: General Consent is an innovative concept that simultaneously informs patients about human research in accordance with Swiss regulations and promotes research with routinely collected data and biological samples in an era with large information repositories. Our results show that medical and demographic factors may influence a patient’s choice. Therefore, approaching these populations and taking additional care to adequately inform and ensure ethical conformity and behaviour is essential. Flexible communication channels may help us reach this goal

O emprego do agulhamento seco no tratamento da dor miofascial mastigatória e cervical

BACKGROUND AND OBJECTIVES: Dry needling is an interventionist, minimally invasive technique, used in the treatment of myofascial pain. The objective of this study was to describe the use of dry needling and to perform a critical literature analysis about the technical aspects of its use by qualified health care professionals. CONTENTS: A search in the literature was carried out for books in English, review articles, randomized controlled or quasi-randomized clinical trials, blind or double-blind and published case studies series in Portuguese or in English. The following databases were used: Cochrane, LILACS, and Pubmed. Articles published from September 1996 to January 2017 were selected according to the following keywords: dry needling versus myofascial pain syndrome versus temporomandibular joint dysfunction syndrome) versus trigger points versus musculoskeletal manipulations versus trapezius muscle, superficial back muscles versus masseter muscle versus secular muscle versus pterygoid muscles versus digastric muscle, neck muscles. Reports of clinical cases, “open-label” studies, studies with animal models and articles not related to DN were excluded. After the matching descriptors and the implementation of inclusion and exclusion criteria, we selected six articles. CONCLUSION: The diagnosis of myofascial pain can be a difficult task since it can simulate different masticatory system pain, from a toothache to a trigeminal neuropathic pain. This can be minimized with proper history taking, clinical examination involving muscle palpation, as well as the own experience and professional training. The deactivation of myofascial trigger points should be a priority in myofascial pain therapy since there is a significant improvement of local and referred pain when we use this approach. Despite the favorable results of studies about the use of dry needling in myofascial pain treatment related to temporomandibular joint dysfunction and the cervical region, the literature still lacks studies with a high level of evidence proving the effectiveness and efficacy of this technique. This is a minimally invasive, low cost, and safe therapy that provides local, segmental, extra segmental and placebo effects. Therefore, its use should be recommended by different health professionals in cases of myofascial pain.JUSTIFICATIVA E OBJETIVOS: O agulhamento seco é uma técnica intervencionista, minimamente invasiva, utilizada no tratamento da dor miofascial. O objetivo deste estudo foi descrever o emprego do agulhamento seco e realizar a análise crítica da literatura sobre os aspectos técnicos de sua utilização por profissionais capacitados da área da saúde. CONTEÚDO: Foi realizada uma busca na literatura por livros em inglês, artigos de revisão, estudos clínicos controlados randomizados ou quase-randomizados, encobertos, ou duplamente encobertos e estudos de séries de casos publicados em português ou inglês. Foram utilizadas as seguintes bases de dados: Cochrane, LILACS e Pubmed. Foram selecionados artigos publicados no período de setembro de 1996 a janeiro de 2017, recrutados após a utilização dos seguintes descritores: agulhamento seco versus síndromes da dor miofascial versus síndrome da disfunção da articulação temporomandibular versus pontos-gatilho versus manipulações musculoesqueléticas versus músculo trapézio (superficial back muscles) versus músculo masseter versus músculo temporal versus músculo pterigoideo versus músculo digástrico. Foram excluídos relatos de casos clínicos, estudos abertos “open-label”, estudos em modelos animais e artigos não relacionados ao agulhamento seco. Após o cruzamento dos descritores e aplicação dos critérios de inclusão e exclusão, foram selecionados seis artigos. CONCLUSÃO: O diagnóstico da dor miofascial pode se apresentar como uma tarefa difícil, uma vez que ela pode simular diferentes algias do sistema mastigatório, desde uma odontalgia até uma dor neuropática trigeminal. Isso pode ser minimizado com uma adequada anamnese, exame clínico envolvendo palpação muscular, além da própria experiência e treinamento profissional. A desativação dos pontos-gatilho miofasciais deve ser prioridade na abordagem terapêutica da dor miofascial já que é observada melhora significativa da dor local e referida, quando essa é realizada. Apesar de resultados favoráveis em estudos sobre o agulhamento seco no tratamento da dor miofascial, relacionada à disfunção temporomandibular e a região cervical, ainda faltam na literatura pesquisas com elevado nível de evidência que comprovem a eficácia e a eficiência dessa técnica. Essa é uma terapia minimamente invasiva, de baixo custo, segura e apresenta efeitos locais, segmentares, extrassegmentares e placebo. Diante do exposto, pode-se recomendar seu emprego por diferentes profissionais da área da saúde nos casos da dor miofascial

How COVID-19 changed clinical research strategies: a global survey

Objective Clinical research has faced new challenges during the COVID-19 pandemic, leading to excessive operational demands affecting all stakeholders. We evaluated the impact of COVID-19 on clinical research strategies and compared different adaptations by regulatory bodies and academic research institutions in a global context, exploring what can be learned for possible future pandemics. Methods We conducted a cross-sectional online survey and identified and assessed different COVID-19-specific adaptation strategies used by academic research institutions and regulatory bodies. Results All 19 participating academic research institutions developed and followed similar strategies, including preventive measures, manpower recruitment, and prioritisation of COVID-19 projects. In contrast, measures for centralised management or coordination of COVID-19 projects, project preselection, and funding were handled differently amongst institutions. Regulatory bodies responded similarly to the pandemic by implementing fast-track authorisation procedures for COVID-19 projects and developing guidance documents. Quality and consistency of the information and advice provided was rated differently amongst institutions. Conclusion Both academic research institutions and regulatory bodies worldwide were able to cope with challenges during the COVID-19 pandemic by developing similar strategies. We identified some unique approaches to ensure fast and efficient responses to a pandemic. Ethical concerns should be addressed in any new decision-making process

Biodegradable films with high starch content made by blown extrusion: solubility and effective diffusion coefficients and water vapor permeability

O grande volume de plástico descartado atualmente tem causado problemas sanitários e ambientais. Investigações têm sido feitas sobre a produção de filmes plásticos a partir de polímeros de fontes renováveis, como o amido de mandioca, que é abundante e de baixo custo no Brasil. Este trabalho teve como objetivo a caracterização quanto às propriedades de sorção de água de filmes biodegradáveis com alto teor de amido de mandioca termoplástico e poli(butileno adipato co-tereftalato) (PBAT), produzidos por extrusão. Foram determinadas a permeabilidade ao vapor de água dos filmes, isotermas de sorção de água e os coeficientes de solubilidade (ß) e de difusão efetivo (Dw) de água. As propriedades de sorção de água de filmes de blendas de ATp/PBAT com alto teor de amido são afetadas pela umidade relativa do ar e pelo teor de amido dos filmesPostprint (published version

37628 EFFECTS OF NEUROMUSCULAR ELECTRICAL STIMULATION ON THE MASTICATORY MUSCLES AND PHYSIOLOGIC SLEEP VARIABLES IN ADULTS WITH CEREBRAL PALSY: A NOVEL THERAPY APPROACH- PILOT STUDY

Cerebral palsy (CP) is a term employed to define a group of non-progressive neuromotor disorders caused by damage to the immature or developing brain, with consequent limitations regarding movement and posture. CP may impair orapharygeal muscle tone, leading to a compromised chewing function and to sleep disorders (such as obstructive sleep apnea). Thirteen adults with CP underwent bilateral masseter and temporalis neuromuscular electrical stimulation (NMES) therapy. The effects on the masticatory muscles and sleep variables were evaluated using electromyography (EMG) and polysomnography (PSG), respectively, prior and after 2 months of NMES. EMG consisted of 3 tests in different positions: rest, mouth opening and maximum clenching effort (MCE). EMG values in the rest position were 100% higher than values recorded prior to therapy for all muscles analyzed (p < 0.05); mean mouth opening increased from 38.0 ± 8.0 to 44.0 ± 10.0 cm (p = 0.03). A significant difference in MCE was found only for the right masseter. PSG revealed an improved in the AHI from 7.2±7.0/h to 2.3±1.5/h (p < 0.05); total sleep time improved from 185 min to 250 min (p = 0.04) and minimun SaO2 improved from 83.6 ± 3.0 to 86.4 ± 4.0 (p = 0.04). NMES performed over a two-month period led to improvements in the electrical activity of the masticatory muscles at rest, mouth opening, isometric contraction and sleep variables, including the elimination of obstructive sleep apnea events in patients with CP. Trial registration: ReBEC RBR994XFS http://www.ensaiosclinicos.gov.br.Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES

Transurethral injection of autologous muscle precursor cells for treatment of female stress urinary incontinence: a prospective phase I clinical trial

INTRODUCTION AND HYPOTHESIS The purpose was to investigate the safety and feasibility of transurethral injections of autologous muscle precursor cells (MPCs) into the external urinary sphincter (EUS) to treat stress urinary incontinence (SUI) in female patients. METHODS Prospective and randomised phase I clinical trial. Standardised 1-h pad test, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), urodynamic study, and MRI of the pelvis were performed at baseline and 6 months after treatment. MPCs gained through open muscle biopsy were transported to a GMP facility for processing and cell expansion. The final product was injected into the EUS via a transurethral ultrasound-guided route. Primary outcomes were defined as any adverse events (AEs) during follow-up. Secondary outcomes were functional, questionnaire, and radiological results. RESULTS Ten female patients with SUI grades I-II were included in the study and 9 received treatment. Out of 8 AEs, 3 (37.5%) were potentially related to treatment and treated conservatively: 1 urinary tract infection healed with antibiotics treatment, 1 dysuria and 1 discomfort at biopsy site. Functional urethral length under stress was 25 mm at baseline compared with 30 mm at 6 months' follow-up (p=0.009). ICIQ-UI-SF scores improved from 7 points at baseline to 4 points at follow-up (p=0.035). MRI of the pelvis revealed no evidence of tumour or necrosis, whereas the diameter of the EUS muscle increased from 1.8 mm at baseline to 1.9 mm at follow-up (p=0.009). CONCLUSION Transurethral injections of autologous MPCs into the EUS for treatment of SUI in female patients can be regarded as safe and feasible. Only a minimal number of expected and easily treatable AEs were documented

Evolution to a Competency-Based Training Curriculum for Pharmaceutical Medicine Physicians in Switzerland

In Switzerland, Pharmaceutical Medicine has existed as one of 46 physician specialties accredited by the Federal Office of Public Health for more than 20 years. As a medical-scientific discipline, our goal is to enable best possible therapeutic coverage for the benefit of patients and society through a medical need-based development and optimal use of medicinal products. The role of the specialist in Pharmaceutical Medicine is to closely collaborate with various stakeholders of the healthcare system in the context of the discovery, research, development and approval of new medicinal products, as well as safe and effective use of new and established medicinal products in daily clinical practice. The post-graduate training consists of 2 years of patient-related clinical work, followed by 3 years of vocational training at certified training centers in Pharmaceutical Medicine. This also includes completion of an academic post-graduate diploma in Pharmaceutical Medicine (30 ECTS) according to the IFAPP/PharmaTrain syllabus and a 1 day board exam. As part of an ongoing revision of the training curriculum, we are developing a Swiss Catalog of Core Competencies in Pharmaceutical Medicine (SC3-PM), based on the IFAPP competency framework for drug development specialists in industry. In this article we discuss how we adapt the scope of the IFAPP competency framework to better reflect such roles in academic institutions or regulatory bodies in Switzerland

The effects of oat bran and soy flour on humoral immune response in rats fed hypercholesterolaemic diets

Previous studies have demonstrated the immunological and hypercholesterolaemic effects of soluble dietary fibre and soy protein in rats. In this study, we evaluated the effects of oat bran and soy flour on humoral immune response in Wistar rats fed hypercholesterolaemic diets. Animals (6 groups) fed with different diets for 6 wks were inoculated twice with antigen (IgY). Plasma samples were collected after each inoculation and anti-IgY antibody (IgM, IgG1 and IgG2a) levels were evaluated by ELISA. Animals receiving 1% cholesterol presented an increase in anti-IgY IgG1 and a reduction in anti-IgY IgM and IgG2a relative to control animals. These effects were abrogated in animals fed 1% cholesterol and oat bran or oat bran+soy protein, but not in animals fed 1% cholesterol and soy protein. Diets containing 1% cholesterol resulted in hepatic lesions and higher liver and spleen relative weights, but did not affect lipid profile, weight gain, food intake, or food conversion efficiency. In conclusion, a high-cholesterol diet influences classes of antibodies produced in response to an antigen in a way that can be reversed by oat bran

Cancer Biomarker Discovery: The Entropic Hallmark

Background: It is a commonly accepted belief that cancer cells modify their transcriptional state during the progression of the disease. We propose that the progression of cancer cells towards malignant phenotypes can be efficiently tracked using high-throughput technologies that follow the gradual changes observed in the gene expression profiles by employing Shannon's mathematical theory of communication. Methods based on Information Theory can then quantify the divergence of cancer cells' transcriptional profiles from those of normally appearing cells of the originating tissues. The relevance of the proposed methods can be evaluated using microarray datasets available in the public domain but the method is in principle applicable to other high-throughput methods. Methodology/Principal Findings: Using melanoma and prostate cancer datasets we illustrate how it is possible to employ Shannon Entropy and the Jensen-Shannon divergence to trace the transcriptional changes progression of the disease. We establish how the variations of these two measures correlate with established biomarkers of cancer progression. The Information Theory measures allow us to identify novel biomarkers for both progressive and relatively more sudden transcriptional changes leading to malignant phenotypes. At the same time, the methodology was able to validate a large number of genes and processes that seem to be implicated in the progression of melanoma and prostate cancer. Conclusions/Significance: We thus present a quantitative guiding rule, a new unifying hallmark of cancer: the cancer cell's transcriptome changes lead to measurable observed transitions of Normalized Shannon Entropy values (as measured by high-throughput technologies). At the same time, tumor cells increment their divergence from the normal tissue profile increasing their disorder via creation of states that we might not directly measure. This unifying hallmark allows, via the the Jensen-Shannon divergence, to identify the arrow of time of the processes from the gene expression profiles, and helps to map the phenotypical and molecular hallmarks of specific cancer subtypes. The deep mathematical basis of the approach allows us to suggest that this principle is, hopefully, of general applicability for other diseases

Measurement of the Splitting Function in &ITpp &ITand Pb-Pb Collisions at root&ITsNN&IT=5.02 TeV

Data from heavy ion collisions suggest that the evolution of a parton shower is modified by interactions with the color charges in the dense partonic medium created in these collisions, but it is not known where in the shower evolution the modifications occur. The momentum ratio of the two leading partons, resolved as subjets, provides information about the parton shower evolution. This substructure observable, known as the splitting function, reflects the process of a parton splitting into two other partons and has been measured for jets with transverse momentum between 140 and 500 GeV, in pp and PbPb collisions at a center-of-mass energy of 5.02 TeV per nucleon pair. In central PbPb collisions, the splitting function indicates a more unbalanced momentum ratio, compared to peripheral PbPb and pp collisions.. The measurements are compared to various predictions from event generators and analytical calculations.Peer reviewe