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Sam Eldabe, Ashish Gulve, Simon Thomson, Ganesan Baranidharan, Rui Duarte, Susan Jowett, Harbinder Sandhu, Raymond Chadwick, Morag Brookes, Anisah Tariq, Jenny Earle, Jill Bell, Anu Kansal, Shelley Rhodes, Rod S Taylor
BACKGROUND: The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and cost-effectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device. METHODS/DESIGN: The TRIAL-STIM Study is a superiority, parallel-group, three-centre, randomised controlled trial in patients with chronic neuropathic pain with a nested qualitative study and economic evaluation. The study will take place in three UK centres: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital); Basildon and Thurrock University Hospitals NHS Foundation Trust; and Leeds Teaching Hospitals NHS Trust...
November 16, 2018: Trials
Dylan A Cutler, Alana K Shaw, Sheila M Pride, Mohamed A Bedaiwy, Anthony P Cheung
BACKGROUND: Polycystic ovary syndrome (PCOS) affects between 8 and 18% of women and is the leading cause of female anovulatory infertility. Unfortunately, common treatments for women trying to conceive can be ineffective as well as disruptive or harmful to patients' quality of life. Despite evidence that women with PCOS have expressed the need for alternative fertility treatments, lifestyle interventions incorporating a nutritional plan with supplementation, increased physical activity, and techniques for stress management have not been combined as a program and studied in this population...
November 16, 2018: Trials
Rui Zhu, Xianglong Xu, Yong Zhao, Manoj Sharma, Zumin Shi
BACKGROUND: The consumption of edible oils in China has increased rapidly in recent years, and the total amount of edible-oil intake in the country has ranked first in the world. The choice and intake of edible oils, as a source of fats, are important factors that affect people's health. Many chronic diseases are closely associated with high-calorie and saturated-fat intake. The influence of traditional concepts that promote the use of edible oils among women, particularly housewives, plays a key role in a household's diet and nutrition because the diet-related knowledge, attitude and behaviour of housewives are dominant factors in planning and preparing their family's meals...
November 16, 2018: Trials
Fatemeh Haidari, Abdollah Hojhabrimanesh, Bizhan Helli, Seyed Saeid Seyedian, Kambiz Ahmadi-Angali
BACKGROUND: Excessive hepatic fat is associated with increased metabolic risk factors, production of inflammatory factors, and oxidative stress. High protein intake might trigger an increased hepatic lipid oxidation through an increase in hepatic energy expenditure. Furthermore, the majority of randomized controlled trials (RCT) in humans have failed to show whether carotenoids can be used to prevent and treat non-alcoholic fatty liver disease (NAFLD). However, it is notable and contradictory that NAFLD is rapidly escalating in Iran and other countries with lower intakes of fruit and vegetables (as sources of β-cryptoxanthin [β-CX] and carbohydrates) and higher intake of carbohydrates (as an agent of NAFLD); and the effects of β-CX and a high protein diet (HPD) on NAFLD need to be investigated further...
November 16, 2018: Trials
Clare van Miert, Ricardo M Fernandes, Helen Eccleson, Emma Bedson, Steven Lane, Matthew Peak, Kent Thorburn, Vanessa Compton, Kerry Woolfall, David Lacy, Paula Williamson, Paul S McNamara
BACKGROUND: Bronchiolitis is an acute lower respiratory infection which predominantly affects young children. Treatment for bronchiolitis is limited to supportive therapy. Nasal oxygen therapy is part of routine care, and delivery now incorporates varying levels of non-invasive continuous positive airway pressure and/or high-flow nasal cannula oxygen therapy. Despite wide clinical use, there remains a lack of evidence on the comparative effectiveness and safety of these interventions...
November 14, 2018: Trials
Ofer Sadan, Owen Samuels, William H Asbury, John J Hanfelt, Kai Singbartl
BACKGROUND: Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening condition that results from a ruptured cerebral vessel. Cerebral edema and vasospasm are common complications and frequently require treatment with hypertonic solutions, in particular hypertonic sodium chloride (NaCl). We have previously shown that hyperchloremia in patients with aSAH given hypertonic NaCl is associated with the development of acute kidney injury (AKI), which leads to higher morbidity and mortality...
November 14, 2018: Trials
Simone P Haller, Joel Stoddard, Caroline MacGillivray, Kelsey Stiles, Gretchen Perhamus, Ian S Penton-Voak, Yair Bar-Haim, Marcus R Munafò, Melissa A Brotman
BACKGROUND: Severe, chronic, and impairing irritability is a common presenting clinical problem in youth. Indeed, it was recently operationalized as disruptive mood dysregulation disorder (DMDD) in the DSM-5. However, to date, there are no evidence-based treatments that were specifically developed for DMDD. The current randomized controlled trial assesses the efficacy of a computer-based cognitive training intervention (Interpretation Bias Training; IBT) in youth with DMDD. IBT aims to reduce irritability by altering judgments of ambiguous face-emotions through computerized feedback...
November 14, 2018: Trials
Deborah A Hall, Charity Moore, Cynthia Comella
INTRODUCTION: Recruitment of sufficient patients with Parkinson disease into clinical trials is a barrier to successful, timely study completion. Non-pharmacologic studies have shown to be even more challenging for recruitment, despite some studies focusing on de novo Parkinson disease populations. This paper describes successful recruitment techniques from a randomized exercise clinical trial in Parkinson disease. METHODS: Several recruitment strategies were used to enroll de novo patients with Parkinson disease into a year-long clinical trial...
November 14, 2018: Trials
Dirk P A Versteegden, Magaly J J Van Himbeeck, Simon W Nienhuijs
BACKGROUND: The expansion of digital devices and widespread access to the Internet has opened up opportunities to provide patients with more personal information. It can be hypothesized that eHealth in addition to standard care could enhance clinical outcomes such as increased weight loss, co-morbidity reduction, and commitment to the program. The beneficial value of incorporating eHealth applications as standard postoperative care is yet to be established. In this trial, the value of different levels of eHealth are assessed...
November 14, 2018: Trials
Christina Reinauer, Rabea Viermann, Katharina Förtsch, Hannah Linderskamp, Petra Warschburger, Reinhard W Holl, Doris Staab, Kirsten Minden, Rainer Muche, Matthias Domhardt, Harald Baumeister, Thomas Meissner
BACKGROUND: This cluster-randomised monocentric controlled trial focuses on improving the uptake symptoms of mental health care in adolescents with chronic medical conditions who have been identified by screening to have depression or anxiety. The study aims to determine the efficacy of motivational interviewing (MI) delivered by trained physicians to increase 12- to 20-year-old adolescents' utilisation of psychological health care for symptoms of anxiety or depression. METHODS/DESIGN: In this single-centre approach, n = 1,000 adolescents will be screened (using PHQ-9 and GAD-7), and adolescents with results indicative of anxiety or depressive symptoms (n = 162) will be advised to seek psychological health care in clusters from treating physicians in specialised outpatient departments...
November 14, 2018: Trials
David Lagier, François Fischer, William Fornier, Jean-Luc Fellahi, Pascal Colson, Bernard Cholley, Samir Jaber, Karine Baumstarck, Catherine Guidon
BACKGROUND: Postoperative pulmonary complications (PPCs) are frequent after on-pump cardiac surgery. Cardiac surgery results in a complex pulmonary insult leading to high susceptibility to perioperative pulmonary atelectasis. For technical reasons, ventilator settings interact with the surgical procedure and traditionally, low levels of positive end-expiratory pressure (PEEP) have been used. The objective is to compare a perioperative, multimodal and surgeon-controlled open-lung approach with conventional protective ventilation with low PEEP to prevent PPCs in patients undergoing cardiac surgery...
November 13, 2018: Trials
Haifeng Wang, Jiansheng Li, Xueqing Yu, Su-Yun Li
BACKGROUND: Community-acquired pneumonia, especially severe community-acquired pneumonia (SCAP), remains the leading cause of death in the world. Despite advances in antimicrobial therapy, the mortality rates due to SCAP have not decreased significantly since antibiotics became routinely available. Traditional Chinese medicine (TCM) has been used for treating pneumonia for thousands of years. It is popular and widely practiced in Asia. In recent decades, evidence from both clinicians and patients suggests that TCM has some beneficial effect on SCAP...
November 12, 2018: Trials
Marie Barais, Hélène Vaillant Roussel, David Costa, Jérémy Derriennic, Bruno Pereira, Sébastien Cadier
BACKGROUND: Premature ejaculation (PE) is the most common sexual dysfunction among men. According to patients, the general practitioner (GP) is the appropriate professional with whom to discuss this issue. However, few patients receive the medical help needed because GPs find it difficult to talk to their patients about sex. A previous qualitative study provided six strategies described by GPs who had tackled the topic during consultation. A pilot study showed that using one of these strategies after a training course led to an increase in the rate of consultations where the topic was raised: an increase from 6...
November 12, 2018: Trials
Victoria Borg Debono, Lawrence Mbuagbaw, James Paul, Norman Buckley, Lehana Thabane
BACKGROUND: Sharing interim result measures by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an important issue that can affect trial integrity. Currently, it is unclear if there are demographic factors associated with sharing such information. This study's objective is to primarily explore the demographic factors associated with the DSMB sharing certain interim result measures and secondarily, explore demographic factors associated with the perceived usefulness in sharing certain interim result measures, with non-DSMB members...
November 12, 2018: Trials
Andrew T Fox, Delwyn Catley, Kimber P Richter, Edward F Ellerbeck, Morgan G Brucks, Vlad B Papa, Laura E Martin
BACKGROUND: Most smokers struggle to overcome tobacco addiction. Neuroscientific models of addiction emphasize the importance of brain regions associated with cognitive control and reward to understand the cycle of addiction and relapse. During an attempt at abstinence, the cognitive control system appears to be underpowered to override the heightened reward system of the addicted brain. Thus, one neural target for treatment is to strengthen the cognitive control system. It may be possible to improve the functioning of the cognitive control system via deliberate practice...
November 12, 2018: Trials
Rathi Mahendran, Mihir Gandhi, Rajesh Babu Moorakonda, Jonathan Wong, Madhu Mathi Kanchi, Johnson Fam, Iris Rawtaer, Alan Prem Kumar, Lei Feng, Ee Heok Kua
BACKGROUND: Mild cognitive impairment (MCI) is a phase in cognitive decline when it is still possible to intervene to reverse the decline. Cognitive stimulation delivered through psychosocial interventions provides both psychological intervention and social stimulation to improve cognition. A pilot open-label parallel-arms randomized controlled trial was undertaken to examine the effects of art therapy (AT) and music reminiscence activity (MRA) compared to the control, on the primary outcome of neurocognitive domain assessments in elderly people with MCI...
November 9, 2018: Trials
Elisa Mäkäräinen-Uhlbäck, Heikki Wiik, Jyrki Kössi, Pasi Ohtonen, Tero Rautio
BACKGROUND: A temporary loop ileostomy, which is used to decrease the risk of symptomatic anastamotic leakage after anterior resection and total mesorectal excision (TME), is traditionally closed without any mesh. However, as 44% of incisional site hernias need further repair after stoma closure, attention has increasingly been paid to the use of mesh. Research on the prevention of these hernias is scarce, and no studies comparing different meshes exist. METHOD/DESIGN: The Preloop trial (Clinical Trials NCT03445936) is a prospective, randomized, controlled, multicenter trial to compare synthetic mesh (Parietene Macro™, Medtronic, Minneapolis, MN, USA) and biological implants (Permacol™, Medtronic) at a retromuscular sublay position for the prevention of incisional site hernias after loop-ileostomy closure...
November 9, 2018: Trials
Sean H Lim, Kim M Linton, Graham P Collins, Joke Dhondt, Joshua Caddy, Liz Rossiter, Karan Vadher, Keira Fines, Laura E Rogers, Diana Fernando, Louise Stanton, Andrew J Davies, Peter W M Johnson, Gareth Griffiths
BACKGROUND: Over 12,000 new cases of B-cell malignancies are diagnosed in the UK each year, with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) being the most common subtypes. Standard frontline therapy consists of immunochemotherapy with a CD20 monoclonal antibody (mAb), such as rituximab, delivered in combination with multi-agent chemotherapy. Despite being considered a treatable and potentially curable cancer, approximately 30% of DLBCL cases will relapse after frontline therapy...
November 9, 2018: Trials
Rebecca Forbes, Ased Ali, Alaa Abouhajar, Catherine Brennand, Heather Brown, Sonya Carnell, Thomas Chadwick, Ian Eardley, Jan Lecouturier, Helen Mossop, Ian Pearce, Robert Pickard, Nikesh Thiruchelvam, Katherine Walton, Jennifer Wilkinson, Chris Harding
BACKGROUND: At least half of all adult women will experience infective cystitis (urinary tract infection: UTI) at least once in their life and many suffer from repeated episodes. Recurrent urinary tract infection (rUTI) in adult women is usually treated with long-term, low-dose antibiotics and current national and international guidelines recommend this as the 'gold standard' preventative treatment. Although they are reasonably effective, long-term antibiotics can result in bacteria becoming resistant not only to the prescribed antibiotic but to other antimicrobial agents...
November 9, 2018: Trials
Santiago Hors-Fraile, Shwetambara Malwade, Dimitris Spachos, Luis Fernandez-Luque, Chien-Tien Su, Wei-Li Jeng, Shabbir Syed-Abdul, Panagiotis Bamidis, Yu-Chuan Jack Li
BACKGROUND: Smoking cessation is the most common preventative for an array of diseases, including lung cancer and chronic obstructive pulmonary disease. Although there are many efforts advocating for smoking cessation, smoking is still highly prevalent. For instance, in the USA in 2015, 50% of all smokers attempted to quit smoking, and only 5-7% of them succeeded - with slight deviation depending on external assistance. Previous studies show that computer-tailored messages which support smoking abstinence are effective...
November 9, 2018: Trials
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