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James X Chen, E Paul Wileyto, Michael C Soulen
BACKGROUND: Neuroendocrine tumors (NETs) are the second most common gastrointestinal malignancy after colon cancer. Up to 90% of patients with NETs develop liver metastases, which are a major determinant of symptoms and survival. Current guidelines recommend embolotherapy for progressive or symptomatic NET liver metastases, but the optimal technique among bland embolization, lipiodol chemoembolization, and drug-eluting bead chemoembolization remains unknown and controversial. METHODS/DESIGN: A prospective, open-label, multicenter randomized controlled trial will be conducted in patients with progressive or symptomatic unresectable NET liver metastases...
July 17, 2018: Trials
Mengdi Wang, Zhen Wang, Jingwei Zhou, Weiwei Sun, Ying Wang, Mei Han, Hanwen Yang, Wei Jing Liu, Yaoxian Wang
BACKGROUND: Diabetic kidney disease (DKD) is a major microvascular complication of diabetes mellitus and the primary cause of end-stage renal disease. Existing therapies for DKD are not sufficiently effective. We report the protocol of a pragmatic randomized controlled trial of the use of traditional Chinese herbal medicine to treat patients with DKD. METHODS/DESIGN: This will be a multicenter randomized controlled trial. A total of 266 patients with DKD (106 with early stage, 80 with middle-stage, and 80 with advanced-stage disease) with an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1...
July 17, 2018: Trials
Meili Yu, Siming Li, Siwei Li, Jingen Li, Hao Xu, Keji Chen
BACKGROUND: Preliminary evidence based on clinical observations suggests that meditative exercise may offer potential benefits for patients with chronic heart failure (CHF). Cardiac rehabilitation (CR), as a class-IA indication in clinical practice guidelines, has been established as an effective strategy to improve quality of life and prognosis of CHF patients. Baduanjin exercise is an important component of traditional Chinese Qigong exercises. However, its benefits for CHF have not been rigorously tested...
July 16, 2018: Trials
A J Wade, J S Doyle, E Gane, C Stedman, B Draper, D Iser, S K Roberts, W Kemp, D Petrie, N Scott, P Higgs, P A Agius, J Roney, L Stothers, A J Thompson, M E Hellard
BACKGROUND: To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to treatment. Direct-acting antiviral (DAA) treatment can be provided in primary healthcare services (PHCS), improving accessibility, and, potentially, retention in care. Here, we describe our protocol for assessing the effectiveness of providing DAAs in PHCS, and the impact on the HCV care cascade. In addition, we reflect on the challenges of conducting a model of care study during a period of unprecedented change in HCV care and treatment...
July 16, 2018: Trials
Denise Bernhardt, Adriane Hommertgen, Daniela Schmitt, Rami El Shafie, Angela Paul, Laila König, Johanna Mair-Walther, Johannes Krisam, Christina Klose, Thomas Welzel, Juliane Hörner-Rieber, Jutta Kappes, Michael Thomas, Claus Peter Heußel, Martin Steins, Meinhard Kieser, Jürgen Debus, Stefan Rieken
BACKGROUND: Conventional whole brain radiotherapy (WBRT) has been established as the treatment standard in patients with cerebral metastases from small-cell lung cancer (SCLC), however, it has only modest efficacy and limited prospective data is available for WBRT as well as local treatments such as stereotactic radiosurgery (SRS). METHODS/DESIGN: The present single-center prospective randomized study, conducted at Heidelberg University Hospital, compares neurocognitive function, as objectively measured by significant deterioration in Hopkins Verbal Learning Test - Revised total recall at 3 months...
July 16, 2018: Trials
Qiang Tu, Lily Dongxia Xiao, Shahid Ullah, Jeffrey Fuller, Huiyun Du
BACKGROUND: Although China has a large number of older people living with diabetes and hypertension, the primary care system is underdeveloped and so management of these conditions in community care settings is suboptimal. Studies have shown that the collaborative care model across care settings that address both pharmacology and nonpharmacology interventions can achieve hypertension control for older people with diabetes. Barriers to implementing and evaluating this model of care are widely recognized in low and middle-income countries including China...
July 16, 2018: Trials
Friederike Schaub, Robert Hoerster, Petra Schiller, Moritz Felsch, Daria Kraus, Marouan Zarrouk, Bernd Kirchhof, Sascha Fauser
BACKGROUND: Proliferative vitreoretinopathy (PVR) is the major cause for postoperative failure after vitreo-retinal surgery for primary rhegmatogenous retinal detachment (RRD). Adjunct pharmaceutical therapy was found to be ineffective once PVR is established. Preliminary data suggest that prevention of PVR yields better functional outcome. So far, there is no standard therapy to prevent PVR. METHODS/DESIGN: This is a randomized, double-blind, controlled, multicenter, interventional trial with one interim analysis...
July 16, 2018: Trials
Mardin Rashid, Adrie J M Verhoeven, Monique T Mulder, Reinier Timman, Yvonne van Beek-Nieuwland, Athumani A Athumani, Adrienne A M Zandbergen, Hans E van der Wiel, Eric J G Sijbrands, Kirsten A Berk
BACKGROUND: Patients with type 2 diabetes mellitus (T2D) are prone to micro- and macro-vascular complications. Monomeric and oligomeric flavanols (MOF) isolated from grape seeds (Vitis vinifera) have been linked to improved endothelial function and vascular health. The aim of this study is to determine the effect of a daily supplementation of 200 mg MOF on renal endothelial function of patients with T2D and microalbuminuria. METHODS/DESIGN: For this double-blind, placebo-controlled, randomized, multicenter trial 96 individuals (ages 40-85 years) with T2D and microalbuminuria will be recruited...
July 16, 2018: Trials
Joseph Rigdon, Michael Baiocchi, Sanjay Basu
BACKGROUND: Heterogeneous treatment effects (HTEs), or systematic differences in treatment effectiveness among participants with different observable features, may be important when applying trial results to clinical practice. Current methods suffer from a potential for false detection of HTEs due to imbalances in covariates between candidate subgroups. METHODS: We introduce a new method, matching plus classification and regression trees (mCART), that yields balance in covariates in identified HTE subgroups...
July 16, 2018: Trials
Carina de Araujo, Raquel Crespo Fitz, Daniela Albugeri Nogara, Pedro Schestatsky, Fernando Gerchman
BACKGROUND: Dietary interventions have limited success in promoting sustainable weight loss; new treatments allowing better compliance with hypocaloric diets should be developed. The aim of this trial is to describe the effects of a protocol combining repetitive active transcranial direct current stimulation (tDCS) with a hypocaloric diet on weight loss and food consumption in overweight or obese adults. METHODS/DESIGN: Overweight or obese adults between 20 and 50 years of age with stable weight over the last 4 months will be selected for a 4-week randomized clinical trial of fixed-dose tDCS (20 sessions; 5 consecutive weekdays/wk, 2 mA, 20 minutes) over the right dorsolateral prefrontal cortex associated with a weight loss diet...
July 16, 2018: Trials
Philipp Houben, Elias Khajeh, Ulf Hinz, Phillip Knebel, Markus K Diener, Arianeb Mehrabi
BACKGROUND: The surgical technique used in liver transplantation has undergone constant evolution in an effort to develop a safe, highly standardized procedure. Despite this, the initial step of recipient hepatectomy has not been the focus of clinical research thus far. Due to advanced coagulopathy in liver transplant recipients, this part of the operation still carries the risk of severe hemorrhage. This trial is designed to compare an electrothermal bipolar vessel sealing device (LigaSure™) and an ultrasound dissector (HARMONIC ACE®+7) with standard surgical techniques during the recipients' hepatectomy in liver transplantation...
July 16, 2018: Trials
Dale M Harris, Timo Rantalainen, Makii Muthalib, Liam Johnson, Rachel L Duckham, Stuart T Smith, Robin M Daly, Wei-Peng Teo
BACKGROUND: People with Parkinson's disease (PD) commonly experience postural instability, resulting in poor balance and an increased risk of falls. Exercise-based video gaming (exergaming) is a form of physical training that is delivered through virtual reality technology to facilitate motor learning and is efficacious in improving balance in aged populations. In addition, studies have shown that anodal transcranial direct current stimulation (a-tDCS), when applied to the primary motor cortex, can augment motor learning when combined with physical training...
July 16, 2018: Trials
Yu Tat Chan, Hong Wei Zhang, Yuan Qi Guo, Tony Ngai Ho Chan, Yiu-Keung Kwan, Chun-Kam Lee, Kit Ngan, Zhi-Xiu Lin
BACKGROUND: Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia". Acupuncture is one of the most popular alternative treatment methods for OAB. Little established evidence is available to support the effectiveness of acupuncture for OAB. This study is a pioneer randomized, double-blinded, sham-controlled trial to assess the effectiveness and safety of acupuncture in the elderly population with overactive bladder in Hong Kong...
July 13, 2018: Trials
Donato Giuseppe Leo, Wei Yee Leong, Tina Gambling, Andrew Long, Rebecca Murphy, Helen Jones, Daniel Christopher Perry
BACKGROUND: Perthes' disease is an idiopathic osteonecrosis of a developmental hip that is most frequent in Northern Europe. Currently, the absence of a common set of standardised outcomes makes comparisons between studies of different interventions challenging. This study aims to summarise the outcomes used in clinical research of interventions for Perthes' disease and define a set of core outcomes (COS) to ensure that the variables of primary importance are measured and reported in future research studies investigating Perthes' disease...
July 13, 2018: Trials
Catherine Arundel, Judith Gellatly
BACKGROUND: Conducting research can be time consuming, difficult and challenging. Guidance and pragmatic advice focussing on randomised controlled trial conduct are available but do not necessarily constitute comprehensive guidance. A successful trial is one that recruits to time and target and collects high-quality data within the originally agreed budget. Standardised trial management tools have outlined key project management elements for a successful trial as a method of ensuring good practice in research trials: initiation, planning, execution, monitoring and closure...
July 13, 2018: Trials
Ji Man Hong, Mun Hee Choi, Sung-Il Sohn, Yang-Ha Hwang, Seong Hwan Ahn, Yeong-Bae Lee, Dong-Ick Shin, Ángel Chamorro, Dennis W Choi
BACKGROUND: The potential of neuroprotective agents should be revisited in the era of endovascular thrombectomy (EVT) for acute large-artery occlusion because their preclinical effects have been optimized for ischemia and reperfusion injury. Neu2000, a derivative of sulfasalazine, is a multi-target neuroprotectant. It selectively blocks N-methyl-D-aspartate receptors and scavenges for free radicals. This trial aimed to determine whether neuroprotectant administration before EVT is safe and leads to a more favorable outcome...
July 13, 2018: Trials
Yakup Kulu, Beat P Müller-Stich, Omid Ghamarnejad, Elias Khajeh, Georgios Polychronidis, Mohammad Golriz, Felix Nickel, Laura Benner, Philipp Knebel, Markus Diener, Christian Morath, Martin Zeier, Markus W Büchler, Arianeb Mehrabi
BACKGROUND: Hand-assisted laparoscopic living donor nephrectomy (HALDN) using a periumbilical or Pfannenstiel incision was developed to improve donor outcome after a kidney transplant. The aim of this study was to investigate two methods of hand assistance and kidney removal during HALDN and their effect on the time it takes for the donor to return to normal physical activity. METHODS/DESIGN: This study was initiated in November 2017 and is expected to last for 2 years...
July 13, 2018: Trials
Ruirui Sun, Xiaojuan Hong, Jing Guo, Shuai Yin, Peiming Feng, Lei Lan, Du Lei, Xiaoyan Liu, Xueling Suo, Tao Yin, Tingting Zhang, Liuyang Huang, Feifei Gao, Qiyong Gong, Fanrong Liang, Fang Zeng
BACKGROUND: The mechanism of the long-lasting effect and the relationship between the long-lasting effect and the deqi sensation, which is the key of achieving the acupuncture effect, has not been well investigated. This trial focuses on investigating the possible central mechanism of the long-lasting effect influenced by the deqi sensation. METHODS: A randomized controlled functional brain imaging trial is currently being conducted in Sichuan, China. In total 105 functional dyspepsia (FD) patients will be allocated into three groups: an acupuncture with deqi group, an acupuncture without deqi group, and a wait-list group...
July 13, 2018: Trials
Taline Bavaresco, Ananda Ughini Bertoldo Pires, Vítor Monteiro Moraes, Viviane Maria Osmarin, Denise Tolfo Silveira, Amália de Fátima Lucena
BACKGROUND: Different methods are available for the treatment of venous ulcers. Most current approaches focus on a combination of topical and compressive therapy. Adjuvant low-level laser therapy may be helpful in lesions with a protracted healing course, but evidence for its use is still limited. This paper describes the protocol of a randomized controlled trial designed to compare the effect of adjuvant low-level laser therapy versus conventional venous ulcer tissue repair, evaluated by a nurse using clinical indicators from the Nursing Outcomes Classification (NOC)...
July 12, 2018: Trials
Claire L Macnamara, Erin Cvejic, Gordon B Parker, Andrew R Lloyd, Gina Lee, Jessica E Beilharz, Ute Vollmer-Conna
BACKGROUND: Chronic fatigue syndrome (CFS) and major depressive disorder (MDD) are both debilitating but heterogeneous conditions sharing core features of fatigue, unrefreshing sleep, and impaired functioning. The aetiology of these conditions is not fully understood, and 'best-practice' treatments are only moderately effective in relieving symptoms. Unrecognised individual differences in the response to such treatments are likely to underlie poor treatment outcomes. METHODS/DESIGN: We are undertaking a two-group, parallel, randomised controlled trial (RCT) comparing the effects of a personalised relaxation intervention on sleep quality, daytime symptoms, and functioning in patients with CFS (n = 64) and MDD (n = 64)...
July 11, 2018: Trials
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