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Helsinky declaration

Ruchi Goel, Smriti Nagpal, Sushil Kumar, Ravi Meher, Saurabh Kamal, Sonam Garg
PURPOSE: To evaluate and compare the success rate of transcanalicular laser-assisted dacryocystorhinostomy with endonasal augmentation, with and without intubation, in patients suffering from primary acquired nasolacrimal duct obstruction, at 1 year of follow up. METHODS: A prospective, randomized interventional pilot study was conducted at a tertiary care center, in accordance with the guidelines of Declaration of Helsinki. Sixty eyes of 60 adult patients with primary acquired nasolacrimal duct obstruction were included...
October 20, 2016: Ophthalmic Plastic and Reconstructive Surgery
(no author information available yet)
No abstract text is available yet for this article.
October 2016: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
Pamela S Hinton, Peggy Nigh, John Thyfault
PURPOSE: We previously reported that 12months of resistance training (RT, 2×/wk, N=19) or jump training (JUMP, 3×/wk, N=19) increased whole body and lumbar spine BMD and increased serum bone formation markers relative to resorption in physically active (≥4h/wk) men (mean age: 44±2y; median: 44y) with osteopenia of the hip or spine. The purpose of this secondary analysis was to examine the effects of the RT or JUMP intervention on potential endocrine mediators of the exercise effects on bone, specifically IGF-I, PTH and sclerostin...
October 12, 2016: Bone
M Riishede, C B Laursen, L S Teglbjærg, A T Lassen, G Baatrup
INTRODUCTION: Patients with acute respiratory problems poses a diagnostic challenge because similar symptoms can be caused by various pathological conditions. Focused ultrasound examination (f-US) of the heart and lungs has proven to increase the diagnostic accuracy in these patients. In this protocol of a randomised multicentre trial, we study the effect of f-US of the heart and lungs in patients with respiratory problems performed by emergency physicians (EP) as soon as the patient arrives to the emergency department (ED)...
October 14, 2016: BMJ Open
Camille Yip, Nian-Lin Reena Han, Ban Leong Sng
Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research...
September 2016: Indian Journal of Anaesthesia
Fernando Hellmann, Marta Verdi, Bruno Schlemper Júnior, Volnei Garrafa
No abstract text is available yet for this article.
October 2016: Journal of the Royal Society of Medicine
Helen Grete Orth, Silke Schicktanz
Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low- (middle)-income countries - summarized as transnational biomedical research (TBR) - has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different...
October 4, 2016: Developing World Bioethics
Riaz Agha, Alexander J Fowler, Christopher Limb, Yasser Al Omran, Harkiran Sagoo, Kiron Koshy, Daniyal J Jafree, Mohammed Omer Anwar, Peter McCullogh, Dennis Paul Orgill
INTRODUCTION: The Declaration of Helsinki 2013 encourages the registration of all research studies involving human participants. However, emphasis has been placed on prospective clinical trials, and it is estimated that only 10% of observational studies are registered. In response, Research Registry(®) was launched in February 2015; a retrospectively curated registry that is free and easy to use. Research Registry(®) enables prospective or retrospective registration of studies, including those study types that cannot be registered on existing registries...
2016: Frontiers in Surgery
Soujanya Kaup, Siddharudha Shivalli, Divyalakshmi Ks, Cynthia Arunachalam, Rejitha Chinnu Varghese
INTRODUCTION: Corneal endothelial damage following phacoemulsification is still one of the major concerns of modern day cataract surgery. Although many techniques have been proposed, the risks of posterior capsular rupture and corneal endothelium damage persist. In theory, damage to the corneal endothelium is minimised by delivering the lowest phaco energy only in the direction necessary to emulsify the lens nucleus. Hence, it is believed that the bevel of the needle should be turned towards the nucleus or the nuclear fragment (ie, bevel-down...
2016: BMJ Open
Esther Peters, Ravindra L Mehta, Patrick T Murray, Jürgen Hummel, Michael Joannidis, John A Kellum, Jacques Arend, Peter Pickkers
INTRODUCTION: Acute kidney injury (AKI) occurs in 55-60% of critically ill patients, and sepsis is the most common underlying cause. No pharmacological treatment options are licensed to treat sepsis-associated AKI (SA-AKI); only supportive renal replacement therapy (RRT) is available. One of the limited number of candidate compounds in clinical development to treat SA-AKI is alkaline phosphatase (AP). The renal protective effect of purified bovine intestinal AP has been demonstrated in critically ill sepsis patients...
2016: BMJ Open
Seckin Ulusoy, Mehmet Emre Dinc, Abdullah Dalgic, Murat Topak, Denizhan Dizdar, Abdulhalim İs
INTRODUCTION: The olfactory system is affected by the nutritional balance and chemical state of the body, serving as an internal sensor. All bodily functions are affected by energy loss, including olfaction; hunger can alter odour perception. OBJECTIVE: In this study, we investigated the effect of fasting on olfactory perception in humans, and also assessed perceptual changes during satiation. METHODS: The "Sniffin' Sticks" olfactory test was applied after 16h of fasting, and again at least 1h after Ramadan supper during periods of satiation...
September 12, 2016: Brazilian Journal of Otorhinolaryngology
Karen Hansen Kallesøe, Andreas Schröder, Rikard K Wicksell, Per Fink, Eva Ørnbøl, Charlotte Ulrikka Rask
INTRODUCTION: Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS)...
September 15, 2016: BMJ Open
Vittoradolfo Tambone, Dario Sacchini, Antonio G Spagnolo, Rosa Menga, Giovanna Ricci, Roberto Valenti, Massimiliano Andrea Vitali, Massimo Ciccozzi
OBJECTIVE: The study proposes a possible roadmap for the ethical assessment of sham surgery clinical trials (CTs), focusing on methodological aspects, as a result of the lack of this type of practical tool in the literature/practice. BACKGROUND: Surgical procedures are frequently conducted without closely controlled studies. For this reason, these procedures are less rigorous than those for drug/device clinical trials. The aim of a sham (placebo) surgery CT is to carry out a surgical CT with a legitimate control group...
September 14, 2016: Annals of Surgery
Sorin Hostiuc, Irina Rentea, Eduard Drima, Ionut Negoi
Placebo is a form of simulated medical treatment intended to deceive the patient/subject who believes that he/she received an active therapy. In clinical medicine, the use of placebo is allowed in particular circumstances to assure a patient that he is taken care of and that he/she receives an active drug, even if this is not the case. In clinical research placebo is widely used, as it allows a baseline comparison for the active intervention. If the use of placebo is highly regulated in pharmacological trials, surgery studies have a series of particularities that make its use extremely problematic and regarded less favorably...
2016: BioMed Research International
(no author information available yet)
No abstract text is available yet for this article.
September 2016: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
Rajni Aggarwal, Prashant Babaji, S Senthil Nathan, George Attokaran, S M Santosh Kumar, Sharanpriya Sathnoorkar
AIM: The present study aims to compare the peri-implant bone status around immediately loaded dental implants treated with aminobisphosphonate solution and untreated control implants in terms of clinical and radiographical parameters. MATERIALS AND METHODS: A total of 24 patients were randomly divided equally into two groups. This study was conducted in accordance to the Helsinki's declaration of 1975, revised in 2000, and with the approval of the institutional ethical committee...
July 2016: Journal of International Society of Preventive & Community Dentistry
Leah A Schrubbe, Scott G Ravyts, Bernadette C Benas, Lisa C Campbell, Crystal W Cené, Cynthia J Coffman, Alexander H Gunn, Francis J Keefe, Caroline T Nagle, Eugene Z Oddone, Tamara J Somers, Catherine L Stanwyck, Shannon S Taylor, Kelli D Allen
BACKGROUND: African Americans bear a disproportionate burden of osteoarthritis (OA), with higher prevalence rates, more severe pain, and more functional limitations. One key barrier to addressing these disparities has been limited engagement of African Americans in the development and evaluation of behavioral interventions for management of OA. Pain Coping Skills Training (CST) is a cognitive-behavioral intervention with shown efficacy to improve OA-related pain and other outcomes. Emerging data indicate pain CST may be a promising intervention for reducing racial disparities in OA symptom severity...
2016: BMC Musculoskeletal Disorders
Marilyn J Hammer
The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies...
September 1, 2016: Oncology Nursing Forum
Eric S Ahn, Roger A Dailey, Bryce Radmall
PURPOSE: To describe success rates and long-term outcomes of conjunctivodacryocystorhinostomy (CDCR) with frosted Jones tubes (FJT) for epiphora with proximal outflow obstruction. METHODS: A retrospective chart review of all patients undergoing external and endoscopic CDCR with FJTs by one author (RAD) was performed between January 1, 2006 and November 1, 2014 at the Casey Eye Institute. Patient demographics, etiology of tearing, concurrent endonasal and eyelid procedures, and FJT size were recorded...
August 4, 2016: Ophthalmic Plastic and Reconstructive Surgery
José Tuñón, Ignacio González-Hernández, Lucía Llanos-Jiménez, Joaquín Alonso-Martín, Juan M Escudier-Villa, Nieves Tarín, Carmen Cristóbal, Petra Sanz, Ana M Pello, Álvaro Aceña, Rocío Carda, Miguel Orejas, Marta Tomás, Paula Beltrán, Marta Calero Rueda, Esther Marcos, José María Serrano-Antolín, Carlos Gutiérrez-Landaluce, Rosa Jiménez, Jorge Cabezudo, Alejandro Curcio, Germán Peces-Barba, Emilio González-Parra, Raquel Muñoz-Siscart, María Luisa González-Casaus, Antonio Lorenzo, Ana Huelmos, Javier Goicolea, Borja Ibáñez, Gonzalo Hernández, Luis M Alonso-Pulpón, Jerónimo Farré, Óscar Lorenzo, Ignacio Mahíllo-Fernández, Jesús Egido
INTRODUCTION: Decreased plasma vitamin D (VD) levels are linked to cardiovascular damage. However, clinical trials have not demonstrated a benefit of VD supplements on left ventricular (LV) remodelling. Anterior ST-elevation acute myocardial infarction (STEMI) is the best human model to study the effect of treatments on LV remodelling. We present a proof-of-concept study that aims to investigate whether VD improves LV remodelling in patients with anterior STEMI. METHODS AND ANALYSIS: The VITamin D in Acute Myocardial Infarction (VITDAMI) trial is a multicentre, randomised, double-blind, placebo-controlled trial...
2016: BMJ Open
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