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ethics committee

Adewumi Adediran, Modu Baba Kagu, Tamunomieibi Wakama, Aliyu Ahmadu Babadoko, Dapus Obadiah Damulak, Sunday Ocheni, Marcus Inyama Asuquo
Background. Sickle cell anaemia (SCA) is an inherited condition whose clinical manifestations arise from the tendency of haemoglobin to polymerize and deform red blood cells into characteristic sickle shape. Allogeneic bone marrow transplantation offers a cure. The aim of this study was to determine the level of awareness, knowledge, and acceptance of this beneficial procedure in Nigeria. Materials and Methods. This multicentre cross-sectional study was conducted in 7 tertiary hospitals in Nigeria in 2015. Approval was obtained from each institution's research and ethics committee...
2016: Bone Marrow Research
Jie Meng, Lijing Zhu, Li Zhu, Huanhuan Wang, Song Liu, Jing Yan, Baorui Liu, Yue Guan, Yun Ge, Jian He, Zhengyang Zhou, Xiaofeng Yang
BACKGROUND: To explore the role of apparent diffusion coefficient (ADC) histogram shape related parameters in early assessment of treatment response during the concurrent chemo-radiotherapy (CCRT) course of advanced cervical cancers. METHODS: This prospective study was approved by the local ethics committee and informed consent was obtained from all patients. Thirty-two patients with advanced cervical squamous cell carcinomas underwent diffusion weighted magnetic resonance imaging (b values, 0 and 800 s/mm(2)) before CCRT, at the end of 2nd and 4th week during CCRT and immediately after CCRT completion...
October 22, 2016: Radiation Oncology
Laura Prieto-Borja, Graciela Rodriguez-Sevilla, Alvaro Auñon, Concepción Pérez-Jorge, Enrique Sandoval, Joaquín Garcia-Cañete, Ignacio Gadea, Ricardo Fernandez-Roblas, Antonio Blanco, Jaime Esteban
BACKGROUND: The development of sonication protocols over the last few years has improved the sensitivity of conventional cultures for the diagnosis of prosthetic-joint infection (PJI). However, the development of a new, specifically designed kit for the molecular diagnosis of PJI could provide a major improvement in this field. METHODS: Prostheses retrieved from patients who underwent implant removal from May 2014 to May 2015 were sent for culture, and processed according to a previously defined protocol that included sonication...
October 18, 2016: Enfermedades Infecciosas y Microbiología Clínica
Fabrice Kwiatkowski, Pascal Dessenne, Claire Laquet, Jean-Pierre Daures, Mathilde Gay-Bellile, Yves-Jean Bignon
BACKGROUND: Young women exposed to a high hereditary breast and ovarian cancer (HBOC) risk are particularly vulnerable. They are ignored by health prevention measures but exposed to a stream of contradictory information (medicine, media, Internet). They may feel concerned about surgical prevention issues at a key moment of their identity construction (self, relationship, sexuality). We designed a special psychoeducational intervention to help these women cope better with these difficulties...
October 21, 2016: Trials
David J Pulford, Philipp Harter, Anne Floquet, Catherine Barrett, Dong Hoon Suh, Michael Friedlander, José Angel Arranz, Kosei Hasegawa, Hiroomi Tada, Peter Vuylsteke, Mansoor R Mirza, Nicoletta Donadello, Giovanni Scambia, Toby Johnson, Charles Cox, John K Chan, Martin Imhof, Thomas J Herzog, Paula Calvert, Pauline Wimberger, Dominique Berton-Rigaud, Myong Cheol Lim, Gabriele Elser, Chun-Fang Xu, Andreas du Bois
BACKGROUND: The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. METHODS: An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis...
October 21, 2016: BMC Medical Ethics
Signe Mezinska, Péter Kakuk, Goran Mijaljica, Marcin Waligóra, Dónal P O'Mathúna
BACKGROUND: Conducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method (CCM)...
October 21, 2016: BMC Medical Ethics
Qian Lu, Jihong Wang, Junshu Jiang, Shengnan Wang, Qilan Jia, Yue Wang, Weiping Li, Qin Zhou, Li Lv, Qingwei Li
BACKGROUND: The RGD-toxin protein Lj-RGD3 is a naturally occurring 118 amino acid peptide that can be obtained from the salivary gland of the Lampetra japonica fish. This unique peptide contains 3 RGD (Arg-Gly-Asp) motifs in its primary structure. Lj-RGD3 is available in recombinant form (rLj-RGD3) and can be produced in large quantities using DNA recombination techniques. The pharmacology of the three RGD motif-containing peptides has not been studied. This study investigated the protective effects of rLj-RGD3, a novel polypeptide, against ischemia/reperfusion-induced damage to the brain caused by middle cerebral artery occlusion (MCAO) in a rat stroke model...
2016: PloS One
Kei Itagaki, Minoru Takebayashi, Chiyo Shibasaki, Naoto Kajitani, Hiromi Abe, Mami Okada-Tsuchioka, Shigeto Yamawaki
BACKGROUND: While electroconvulsive therapy (ECT) treatment for depression is highly effective, the high rate of relapse is a critical problem. The current study investigated factors associated with the risk of relapse in mood disorders in patients in which ECT was initially effective. METHOD: The records of 100 patients with mood disorders (61 unipolar depression, 39 bipolar depression) who received and responded to an acute ECT course were retrospectively reviewed...
October 11, 2016: Journal of Affective Disorders
Paul L Schneider, Zhaoping Li
OBJECTIVE: To provide a thorough analysis of the range of ethical concerns that may present in relation to the care of the morbidly obese inpatient over the course of several years of care. METHODS: A narrative of the patient's complex medical care is given, with particular attention to the recommendations of three separate ethics committee consultations that were sought by his health care providers. An ethical analysis of the relevant issues is given within the Principles of Biomedical Ethics framework, highlighting the principles of autonomy, beneficence, non-maleficence, and justice...
2016: Narrative Inquiry in Bioethics
Canna Ghia, Shashank Akerkar, Shailaja Sabnis, Urk Rao, Gautam Rambhad
BACKGROUND / OBJECTIVES: Biologic anti-TNFs in India have improved the patient management. Significant proportions of patients lose response over time or do not respond. Possible explanations are suboptimal trough anti-TNFa concentrations or antibodies to anti-TNFs. The aim of this project was to set up and standardize an independent laboratory to test immunogenicity of anti-TNF biologics (infliximab and etanercept). METHODS: Three rheumatologists piloted this project approved by independent ethics committee and carried out in compliance with ICH/GCP guidelines...
September 2016: Journal of the Association of Physicians of India
Heng Xue, Hui-Yu Ge, Li-Ying Miao, Shu-Min Wang, Bo Zhao, Jin-Rui Wang, Li-Gang Cui
OBJECTIVES: To evaluate the diagnostic performance of contrast-enhanced ultrasound (CEUS) in differential diagnosis of gastric cancer and gastritis, with histological results as reference standard. METHODS: From September 2011 to August 2014, 82 patients (50 males and 32 females; mean age ± SD, 59.5 ± 15.0 years; range 19-91 years) with gastric cancer or gastritis were included in this Ethics Committee-approved prospective study. Conventional ultrasonography (US) and CEUS were applied to distinguish the two lesions, and both qualitative and quantitative features were evaluated...
October 19, 2016: Abdominal Radiology
Mohammad Haghighi, Abbas Sedighinejad, Bahram Naderi Nabi, Cyrus Emiralavi, Gelareh Biazar, Kaveh Mirmozaffari, Cyrus Zahedan, Mehdi Jafari
BACKGROUND: Electroconvulsive therapy (ECT) is a safe and effective mode of therapy for a wide variety of psychiatric disorders. However, it is associated with some disturbing side effects, such as nausea and vomiting, dental and tongue injury, confusion, dizziness, headache, and myalgia. OBJECTIVES: The present study focused on the evaluation of myalgia and headache and their predictors after ECT. PATIENTS AND METHODS: A prospective analytical descriptive study was conducted from October 2014 to January 2015, in an academic hospital in northern Iran...
June 2016: Anesthesiology and Pain Medicine
Nevzat Dabak, Hasan Göçer, Alper Çıraklı
BACKGROUND: Giant Cell Tumor is considered a benign, local and aggressive tumor. Although considered a benign bone tumor, it is still the subject of discussion and research because of the associated local bone destruction, as well as high rates of recurrence and distant metastases. Options are being developed for both surgical techniques and adjuvant therapies. AIMS: The present study evaluated the administration of cryotherapy via a pressurized-spray technique in giant cell tumors of the bone...
September 2016: Balkan Medical Journal
Madhuri S Kurdi, Sindhu Priya Muthukalai
BACKGROUND AND AIMS: Melatonin (MT), a naturally occurring pituitary hormone has a sleep promoting effect. There are very few studies on pre-operative oral MT (0.2-0.5 mg/kg) in children. We planned a study to assess the efficacy of oral MT in two doses and compare it with oral midazolam and placebo for pre-operative anxiolysis, sedation, maintenance of cognition and psychomotor skills, parental separation behaviour and venepuncture compliance. METHODS: This prospective double-blind randomised study was conducted after ethical committee approval on 100 children aged 5-15 years, American Society of Anaesthesiologists physical status I and II undergoing elective surgery at our hospital from January 1, 2014, to December 31, 2014...
October 2016: Indian Journal of Anaesthesia
Q L Huang, D Gao, F G Yue, C G Jiang, T Zhang, L Lei
Objective: To evaluate the efficacy of Bailemian capsule combined with self-help cognitive behavioral therapy (CBTI-SH) in treatment of chronic insomnia. Methods: Approved by the Ethics Committee of the hospital, 60 patients with chronic insomnia were randomly divided into two groups, the test group (Bailemian capsule combined with CBTI-SH) and the control group (CBTI-SH alone). Each group contained 30 cases. After 4 weeks for therapy, the sleep quality, mood and adverse reactions of treatment in patients were evaluated by sleep diary, sleep severity index scale (ISI), self-rating anxiety scale (SAS), self-rating depression scale (SDS) and treatment emergent symptom scale (TESS) respectively...
September 27, 2016: Zhonghua Yi Xue za Zhi [Chinese medical journal]
Yuan Qu, Rui Huang, Lin Li
OBJECTIVES: To compare the ablation results, therapeutic responses and adverse reactions between a low dose (1.1 GBq) or high dose (3.7 GBq) of (131)I in low-/intermediate-risk differentiated thyroid cancer (DTC) patients. The factors influencing the ablation result and therapeutic response were also analyzed. METHODS: The researchers used a random number table to randomly assign the enrolled patients to the low-dose group or high-dose group at a 1:1 ratio, and assessment of ablation result, therapeutic response, and adverse reactions evaluated 6 ± 3 months after therapy...
October 18, 2016: Annals of Nuclear Medicine
T Thomsen, M Aadahl, N Beyer, M L Hetland, K Løppenthin, J Midtgaard, R Christensen, B A Esbensen
BACKGROUND: Patients with rheumatoid arthritis (RA) spend a high proportion of their waking time in sedentary behaviour (SB) and have an increased risk of cardiovascular disease. Reduction of SB and increase in light intensity physical activity has been suggested as a means of improvement of health in patients with mobility problems. Short-term intervention studies have demonstrated that SB can be reduced by behavioural interventions in sedentary populations. To evaluate descriptively the feasibility of recruitment, randomisation, outcome assessments, retention and the acceptability of an individually tailored, theory-based behavioural intervention targeting reduction in daily sitting time in patients with RA...
October 18, 2016: BMC Musculoskeletal Disorders
Adélaïde Doussau, Christine Grady
Ethical concerns about randomising persons to a no-treatment arm in the context of Ebola epidemic led to consideration of alternative designs. The stepped wedge (SW) design, in which participants or clusters are randomised to receive an intervention at different time points, gained popularity. Common arguments in favour of using this design are (1) when an intervention is likely to do more good than harm, (2) all participants should receive the experimental intervention at some time point during the study and (3) the design might be preferable for practical reasons...
October 17, 2016: Journal of Medical Ethics
Vildan Kaya, Aynur Aytekin
AIMS AND OBJECTIVES: To determine the effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants. BACKGROUND: Feeding problems in preterm infants cause delays in hospital discharge, extend mother-infant reunification, and increase medical cost. Nutritive sucking skills of preterm infants may develop by improving non-nutritive sucking skills and increasing sucking experiences. DESIGN: A prospective, randomised controlled trial conducted in the Eastern Turkey...
October 18, 2016: Journal of Clinical Nursing
Jack Drescher, Alan Schwartz, Flávio Casoy, Christopher A McIntosh, Brian Hurley, Kenneth Ashley, Mary Barber, David Goldenberg, Sarah E Herbert, Lorraine E Lothwell, Marlin R Mattson, Scot G McAfee, Jack Pula, Vernon Rosario, D Andrew Tompkins
Conversion therapies are any treatments, including individual talk therapy, behavioral (e.g. aversive stimuli), group therapy or milieu (e.g. "retreats or inpatient treatments" relying on all of the above methods) treatments, which attempt to change an individual's sexual orientation from homosexual to heterosexual. However these practices have been repudiated by major mental health organizations because of increasing evidence that they are ineffective and may cause harm to patients and their families who fail to change...
2016: J Med Regul
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