Effects of small-dose remifentanil combined with index of consciousness monitoring on gastroscopic polypectomy: a prospective, randomized, single-blinded trial
AbstractBackgroundWith the development of painless diagnosis and treatment, remifentanil, a synthetic opioid agonist, is increasingly used in gastroscopy for its rapid, short-term, and potent analgesic effect. However, the dosage of remifentanil used in endoscopy is unclear. Index of consciousness (IOC) is a new anesthesia depth-monitoring indicator that can be divided into index of consciousness 1 (IOC1) and index of consciousness 2 (IOC2); IOC1 is used for estimating a patient ’s sedation state, whereas IOC2 reflects analgesic depth. We hypothesized that combining with IOC1 and IOC2 monitoring may be helpful to ide...
Source: Trials - July 18, 2018 Category: Research Source Type: clinical trials

Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial
DiscussionThe results of this study will provide evidence for the effect of preconceptional orlistat treatment on IVF outcome in overweight/obese women.Trial registrationChinese Clinical Trial Registry,ChiCTR-IPR-17011629. Registered on 11 June 2017. (Source: Trials)
Source: Trials - July 18, 2018 Category: Research Source Type: clinical trials

Effects of traditional Chinese herbal medicine in patients with diabetic kidney disease: study protocol for a randomized controlled trial
We report t... (Source: Trials)
Source: Trials - July 17, 2018 Category: General Medicine Authors: Mengdi Wang, Zhen Wang, Jingwei Zhou, Weiwei Sun, Ying Wang, Mei Han, Hanwen Yang, Wei Jing Liu and Yaoxian Wang Tags: Study protocol Source Type: research

Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial
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 s... (Source: Trials)
Source: Trials - July 17, 2018 Category: General Medicine Authors: James X. Chen, E. Paul Wileyto and Michael C. Soulen Tags: Study protocol Source Type: research

Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial
DiscussionThe RETNET trial is a prospective, multicenter randomized controlled trial designed to determine the optimal embolotherapy technique for NET liver metastases.Trial registrationClinicalTrials.gov,NCT02724540. Registered on March 31, 2016. (Source: Trials)
Source: Trials - July 17, 2018 Category: Research Source Type: clinical trials

Effects of traditional Chinese herbal medicine in patients with diabetic kidney disease: study protocol for a randomized controlled trial
This study will provide evidence of the effectiveness and safety of traditional Chinese herbal medicine in treating patients with DKD.Trial registrationChinese Clinical Trials Registry:ChiCTR-IOR-16010072. Registered on 2 December 2016. (Source: Trials)
Source: Trials - July 17, 2018 Category: Research Source Type: clinical trials

Whole brain radiation therapy alone versus radiosurgery for patients with 1 –10 brain metastases from small cell lung cancer (ENCEPHALON Trial): study protocol for a randomized controlled trial
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 lim... (Source: Trials)
Source: Trials - July 16, 2018 Category: General Medicine Authors: Denise Bernhardt, Adriane Hommertgen, Daniela Schmitt, Rami El Shafie, Angela Paul, Laila K önig, Johanna Mair-Walther, Johannes Krisam, Christina Klose, Thomas Welzel, Juliane Hörner-Rieber, Jutta Kappes, Michael Thomas, Claus Peter Heußel, Martin Ste Tags: Study protocol Source Type: research

Community-based provision of direct-acting antiviral therapy for hepatitis C: study protocol and challenges of a randomized controlled trial
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 healthc... (Source: Trials)
Source: Trials - July 16, 2018 Category: General Medicine Authors: 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 and M. E. Hellard Tags: Study protocol Source Type: research

Baduanjin exercise for patients with ischemic heart failure on phase-II cardiac rehabilitation (BEAR trial): study protocol for a prospective randomized controlled trial
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 indi... (Source: Trials)
Source: Trials - July 16, 2018 Category: General Medicine Authors: Meili Yu, Siming Li, Siwei Li, Jingen Li, Hao Xu and Keji Chen Tags: Study protocol Source Type: research

SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial
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 ... (Source: Trials)
Source: Trials - July 16, 2018 Category: General Medicine Authors: Philipp Houben, Elias Khajeh, Ulf Hinz, Phillip Knebel, Markus K. Diener and Arianeb Mehrabi Tags: Study protocol Source Type: research

Hypertension management for community-dwelling older people with diabetes in Nanchang, China: study protocol for a cluster randomized controlled trial
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... (Source: Trials)
Source: Trials - July 16, 2018 Category: General Medicine Authors: Qiang Tu, Lily Dongxia Xiao, Shahid Ullah, Jeffrey Fuller and Huiyun Du Tags: Study protocol Source Type: research

Prophylactic intravitreal 5-fluorouracil and heparin to prevent proliferative vitreoretinopathy in high-risk patients with retinal detachment: study protocol for a randomized controlled trial
DiscussionThe present trial uses intraoperative intravitreal 5-FU and LMWH as a prophylactic therapy in high-risk patients with primary RRD, aiming to reduce the incidence of PVR in the group that receives the trial drug. Using laser flare photometry to identify high-risk patients for PVR, this trial will test the effectiveness of a simple treatment to prevent PVR.Trial registrationEudraCT no.: 2015-004731-12, registered October 21, 2015; ClinicalTrials.gov Identifier:NCT02834559, registered July 12, 2016. Protocol version: Version 02. Date: September 18, 2016. (Source: Trials)
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

Use of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes mellitus and microalbuminuria (FLAVA trial): study protocol for a randomized controlled trial
DiscussionWe hypothesize that T2D patients with microalbuminuria have a medically determined requirement for MOF and that fulfilling this requirement will result in a decrease in AER and related endothelial biomarkers. If confirmed, this may lead to new insights in the dietary management of patients with T2D.Trial registrationNederlands Trial Register,NTR4669, registered on 7 July 2014. (Source: Trials)
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

Preventing false discovery of heterogeneous treatment effect subgroups in randomized trials
ConclusionsCovariate imbalances may be producing false positives in subgroup analyses. mCART could be a useful tool to help prevent the false discovery of HTE subgroups in secondary analyses of randomized trial data. (Source: Trials)
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

Effect of transcranial direct current stimulation associated with hypocaloric diet on weight loss and metabolic profile in overweight or obesity: study protocol for a double-blind, randomized controlled clinical trial
This study explores the potential role of tDCS as an adjunctive treatment with a hypocaloric diet for obesity management.Trial registrationClinicalTrials.gov,NCT02683902. Registered on 11 January 2016. (Source: Trials)
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

Concurrent exergaming and transcranial direct current stimulation to improve balance in people with Parkinson ’s disease: study protocol for a randomised controlled trial
DiscussionThis will be the first trial to target balance in people with PD with combined exergaming and a-tDCS. We hypothesise that improvements in balance, functional and neurophysiological outcome measures, and neurocognitive outcome measures will be greater and longer-lasting following concurrent exergaming and a-tDCS than in those receiving sham tDCS or usual care.Trial registrationAustralian New Zealand Clinical Trials Registry,ACTRN12616000594426). Registered on 9 May 2016. (Source: Trials)
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

Hypertension management for community-dwelling older people with diabetes in Nanchang, China: study protocol for a cluster randomized controlled trial
This study will therefore test the hypothesis that a hypertension management program built on collaboration between hospitals and community health service centers in China can improve blood pressure control in people aged 60 years and older with diabetes as compared to usual care.MethodsA cluster randomized controlled trial will randomly allocate 10 wards from four hospitals in Nanchang to either an intervention group (N = 5) or a usual care group (N = 5). At least 27 participants will be recruited from each ward and the estimated sample size will be 135 patients in each group. The intervention ...
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial
DiscussionTo our knowledge, this is the first prospective, randomized trial comparing two innovative technical methods of vessel sealing and dissection with standard techniques for recipient hepatectomy. This will be done to detect relevant reduction of intraoperative blood loss during liver transplant. The results of the trial are expected to improve patient outcome and safety after liver transplant and to increase the general safety of this procedure.Trial registrationClinicalTrials.gov,NCT 03323242. Registered on October 26, 2017. (Source: Trials)
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

Baduanjin exercise for patients with ischemic heart failure on phase-II cardiac rehabilitation (BEAR trial): study protocol for a prospective randomized controlled trial
DiscussionThis is the first trial to evaluate the effects of aBaduanjin exercise-based CR program on cardiopulmonary function and exercise tolerance in ischemic CHF patients. If successful, it will prove the value ofBaduanjin exercise in improving cardiopulmonary function and exercise tolerance in patients with ischemic heart failure on phase-II CR, and may further develop a ChineseQigong exercise-based CR framework.Trial registrationClinicalTrials.gov, ID:NCT03229681. Registered retrospectively on 23 July 2017. (Source: Trials)
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

Community-based provision of direct-acting antiviral therapy for hepatitis C: study protocol and challenges of a randomized controlled trial
DiscussionThe Prime Study is the first real-world, randomized, model of care study exploring the impact of community provision of DAA therapy on HCV-treatment uptake and cure. Although the study has faced challenges unique to this period of time characterized by changing treatment and service delivery, the data gained will be of critical importance in shaping health service policy that enables the elimination of HCV.Trial registrationClinicalTrials.gov, ID:NCT02555475. Registered on 15 September 2015. (Source: Trials)
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

Whole brain radiation therapy alone versus radiosurgery for patients with 1 –10 brain metastases from small cell lung cancer (ENCEPHALON Trial): study protocol for a randomized controlled trial
DiscussionRecent evidence suggests that SRS might be a promising treatment option for SCLC patients with brain metastases. The present trial is the first to prospectively investigate the treatment response, toxicity and neurocognition of WBRT and SRS in SCLC patients.Trial registrationClinicaltrials.govNCT03297788. Registered September 29, 2017. (Source: Trials)
Source: Trials - July 16, 2018 Category: Research Source Type: clinical trials

Hand-Assisted laparoscopic donor nephrectomy PERiumbilical versus Pfannenstiel incision and return to normal physical ACTivity (HAPERPACT): study protocol for a randomized controlled trial
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 investi... (Source: Trials)
Source: Trials - July 13, 2018 Category: General Medicine Authors: Yakup Kulu, Beat P. M üller-Stich, Omid Ghamarnejad, Elias Khajeh, Georgios Polychronidis, Mohammad Golriz, Felix Nickel, Laura Benner, Philipp Knebel, Markus Diener, Christian Morath, Martin Zeier, Markus W. Büchler and Arianeb Mehrabi Tags: Study protocol Source Type: research

The outcomes of Perthes ’ disease of the hip: a study protocol for the development of a core outcome set
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 studie... (Source: Trials)
Source: Trials - July 13, 2018 Category: General Medicine Authors: Donato Giuseppe Leo, Wei Yee Leong, Tina Gambling, Andrew Long, Rebecca Murphy, Helen Jones and Daniel Christopher Perry Tags: Study protocol Source Type: research

Safety and Optimal Neuroprotection of neu2000 in acute Ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial
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... (Source: Trials)
Source: Trials - July 13, 2018 Category: General Medicine Authors: Ji Man Hong, Mun Hee Choi, Sung-Il Sohn, Yang-Ha Hwang, Seong Hwan Ahn, Yeong-Bae Lee, Dong-Ick Shin, Ángel Chamorro and Dennis W. Choi Tags: Study protocol Source Type: research

Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial
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 es... (Source: Trials)
Source: Trials - July 13, 2018 Category: General Medicine Authors: Yu Tat Chan, Hong Wei Zhang, Yuan Qi Guo, Tony Ngai Ho Chan, Yiu-Keung Kwan, Chun-Kam Lee, Kit Ngan and Zhi-Xiu Lin Tags: Study protocol Source Type: research

The central mechanism of acupuncture treatment with a long-lasting effect for functional dyspepsia: study protocol for a randomized controlled trial
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 tri... (Source: Trials)
Source: Trials - July 13, 2018 Category: General Medicine Authors: 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 and Fang Zeng Tags: Study protocol Source Type: research

Learning from OCTET – exploring the acceptability of clinical trials management methods
ConclusionOrganisation, openness and positivity are crucial for executing a trial successfully, whilst clear and focussed processes and resources are essential in monitoring and controlling the trial progress. Although derived from a single study, these findings are likely to be applicable to the successful conduct of all trials. Trial managers should consider developing these elements when setting up a study.Trial registrationClinical Trial Registry, ID:ISRCTN73535163. Registered prospectively on 5 April 2011. (Source: Trials)
Source: Trials - July 13, 2018 Category: Research Source Type: clinical trials

Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial
This study is a pioneer randomized, doubl e-blinded, sham-controlled trial to assess the effectiveness and safety of acupuncture in the elderly population with overactive bladder in Hong Kong.Methods/designThis is a randomized, double-center, patient and outcome assessor blinded, sham-controlled trial. The study sample size is 100 patients. Eligible subjects aged between 60 to 90  years old will be recruited into this study. All subjects will be randomly allocated into the active acupuncture group or sham acupuncture group in a 1: 1 ratio. Participants who are allocated into the active acupuncture group will receive a...
Source: Trials - July 13, 2018 Category: Research Source Type: clinical trials

Safety and Optimal Neuroprotection of neu2000 in acute Ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial
DiscussionThe trial results may provide information on new therapeutic options as multi-target neuroprotection might mitigate reperfusion injury in patients with acute ischemic stroke before EVT.Trial registrationClinicalTrials.gov, ID:NCT02831088. Registered on 13 July 2016. (Source: Trials)
Source: Trials - July 13, 2018 Category: Research Source Type: clinical trials

Hand-Assisted laparoscopic donor nephrectomy PERiumbilical versus Pfannenstiel incision and return to normal physical ACTivity (HAPERPACT): study protocol for a randomized controlled trial
This study was initiated in November 2017 and is expected to last for 2 years. To be eligible for the study, donors must be more than 20  years of age and must not be receiving permanent pain therapy. Only donors with a single artery and vein in the graft are being enrolled in this trial. Donors with infections or scars in the periumbilical or hypogastric area, bleeding disorders, chronic use of immunosuppressive agents, or active i nfection will be excluded. Donors will be randomly allocated to either a control arm (periumbilical incision) or an intervention arm (Pfannenstiel incision). The sample size was calculated...
Source: Trials - July 13, 2018 Category: Research Source Type: clinical trials

The central mechanism of acupuncture treatment with a long-lasting effect for functional dyspepsia: study protocol for a randomized controlled trial
DiscussionThe results of this trial will allow us to compare the changes of acupuncture therapeutic effect at three time points (the baseline vs. the end of treatment vs. the end of follow-up), and investigate the potential central mechanism of the long-lasting effect influenced by acupuncture withdeqi. This trial aims to re-identify the long-lasting effect of acupuncture and investigate its central mechanism, and to further explore the central influence ofdeqi sensation on the long-lasting effect.Trial registrationChinese Clinical Trial Registry, IDF:ChiCTR-IOR-15006523. Registered on 5 June 2015. (Source: Trials)
Source: Trials - July 13, 2018 Category: Research Source Type: clinical trials

The outcomes of Perthes ’ disease of the hip: a study protocol for the development of a core outcome set
This study aims to summarise the outcomes used in clin ical 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.MethodsA systematic review of the current literature will be used to identify a list of outcomes reported in previous studies. Additional important outcomes will be sought by interviewing a group of children with Perthes ’ disease, adults who were treated with the disease in infancy and parents of children with the disease. This...
Source: Trials - July 13, 2018 Category: Research Source Type: clinical trials

Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial
DiscussionThis randomized clinical trial will use a  validated method to investigate the effect of a novel intervention for the treatment of venous ulcers.Trial registrationClinicalTrials.gov,NCT03229330. Registered on July 2017. (Source: Trials)
Source: Trials - July 12, 2018 Category: Research Source Type: clinical trials

Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial
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... (Source: Trials)
Source: Trials - July 12, 2018 Category: General Medicine Authors: Taline Bavaresco, Ananda Ughini Bertoldo Pires, V ítor Monteiro Moraes, Viviane Maria Osmarin, Denise Tolfo Silveira and Amália de Fátima Lucena Tags: Study protocol Source Type: research

Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial
In distal pancreatectomy (DP), it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the sp... (Source: Trials)
Source: Trials - July 11, 2018 Category: General Medicine Authors: Suguru Yamada, Tsutomu Fujii, Manabu Kawai, Toshio Shimokawa, Masafumi Nakamura, Yoshiaki Murakami, Sohei Satoi, Hidetoshi Eguchi, Yuichi Nagakawa, Yasuhiro Kodera and Hiroki Yamaue Tags: Study protocol Source Type: research

Efficacy and indication optimization of Chinese medicine (Tiao-Chang Ke-Min granules) for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial
Irritable bowel syndrome (IBS) is a chronic, recurring condition, prevalent in the general population. Current medication treatments usually leave patients undertreated. Nowadays, Chinese medicine (CM) is bein... (Source: Trials)
Source: Trials - July 11, 2018 Category: General Medicine Authors: Qian Li, Bei-ping Zhang, Shao-gang Huang, Wen-wei Ouyang, Jian-hui Xie, Ze-huai Wen and Xiao-bo Yang Tags: Study protocol Source Type: research

Planning a future randomized clinical trial based on a network of relevant past trials
The important role of network meta-analysis of randomized clinical trials in health technology assessment and guideline development is increasingly recognized. This approach has the potential to obtain conclus... (Source: Trials)
Source: Trials - July 11, 2018 Category: General Medicine Authors: Georgia Salanti, Adriani Nikolakopoulou, Alex J. Sutton, Stephan Reichenbach, Sven Trelle, Huseyin Naci and Matthias Egger Tags: Methodology Source Type: research

Personalised relaxation practice to improve sleep and functioning in patients with chronic fatigue syndrome and depression: study protocol for a randomised controlled trial
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 aetiolo... (Source: Trials)
Source: Trials - July 11, 2018 Category: General Medicine Authors: Claire L. Macnamara, Erin Cvejic, Gordon B. Parker, Andrew R. Lloyd, Gina Lee, Jessica E. Beilharz and Ute Vollmer-Conna Tags: Study protocol Source Type: research

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial
Whilst pathways relating to the early stages of stroke care have become well established, strategies for longer-term care are less developed and longer-term outcomes remain poor for many stroke survivors. New Sta... (Source: Trials)
Source: Trials - July 11, 2018 Category: General Medicine Authors: Natasha K. Hardicre, Thomas F Crocker, Alan Wright, Louisa-Jane Burton, Seline Ozer, Ross Atkinson, Allan House, Jenny Hewison, Christopher McKevitt, Anne Forster and Amanda J. Farrin Tags: Study protocol Source Type: research

Improving cardiovascular health and quality of life in people with severe mental illness: study protocol for a randomised controlled trial
This study constitutes the first large-scale trial, worldwide, using the Flinders Program with this population. By combining a standardised yet flexible motivational process with a targeted set of evidence-based interventions, the chief aim is to reduce CVD risk by 20%. If achieved, this will be a ground-breaking outcome, and the program will be subsequently translated nationwide and abroad. The trial will be of great interest to people with mental illness, family carers, mental health services, governments and primary care providers because the Flinders Program can be delivered in diverse settings by any clinical discipli...
Source: Trials - July 11, 2018 Category: Research Source Type: clinical trials

Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial
This study targets chronic periodontitis, an oral inflammatory disease of microbial etiology causing persistent inflammation in ESRD. Unlike the previously reported episodic periodontal interventions, we propose to control periodontal inflammation with a continuous maintenance and oral health behavior modifications. We hypothesize that this strategy will improve systemic inflammation and oxidative stress, oral health and quality of life within the 6-month observation period.MethodsThe rePAIR (novelPAradigm to improveInflammatory burden in ESRD) study is a pilot and feasibility, parallel-arm, and randomized controlled clini...
Source: Trials - July 11, 2018 Category: Research Source Type: clinical trials

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial
DiscussionThis process evaluation will identify factors that aid and impede implementation of the New Start intervention  and improve understanding of this novel approach to longer-term stroke care.Trial registrationISRCTN Registry,ISRCTN38920246. Registered on 22 June 2016. (Source: Trials)
Source: Trials - July 11, 2018 Category: Research Source Type: clinical trials

Personalised relaxation practice to improve sleep and functioning in patients with chronic fatigue syndrome and depression: study protocol for a randomised controlled trial
DiscussionThis is the first RCT examining the effects of a personalised relaxation intervention, pre-tested to maximise the autonomic relaxation response, in patients with unrefreshing sleep and fatigue attributed to CFS or MDD. Detailed monitoring of sleep quality and symptoms will enable sensitive detection of improvements in the core symptoms of these debilitating conditions. In addition, repeated monitoring of autonomic functioning can elucidate mechanisms underlying potential benefits. The findings have translational potential, informing novel, personalised symptom management techniques for these conditions, with the ...
Source: Trials - July 11, 2018 Category: Research Source Type: clinical trials

Planning a future randomized clinical trial based on a network of relevant past trials
ConclusionsWhen used judiciously, conditional trial design could significantly reduce the required resources for a new study and prevent experimentation with an unnecessarily large number of participants. (Source: Trials)
Source: Trials - July 11, 2018 Category: Research Source Type: clinical trials

Efficacy and indication optimization of Chinese medicine ( Tiao-Chang Ke-Min granules) for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial
DiscussionThis trial may provide high-quality evidence on the efficacy and safety of TCKM granules for IBS and a more accurate indication. Importantly, this trial will provide a new research method for improving the therapeutic effects of CM for clinicians and researchers. To address IBS relapse assessment, a series of special definitions of relapse incidents has been made for this trial.Trial registrationChinese Clinical Trial Registry, ID:ChiCTR-IOR-17010600. Registered on 9 February 2017. (Source: Trials)
Source: Trials - July 11, 2018 Category: Research Source Type: clinical trials

Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial
This study is designed as a multicentre prospective randomised phase III trial. Eligible patients will be centrally randomised to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas). This study aims to establish the non-inferiority of the safety of Arm B compared with that of Arm A; the primary endpoint is the incidence of PF (ISGPF grade B/C).DiscussionThe COSMOS-DP trial will establish the safety of this procedure, such that it can be recommended with more confidence. The use of this procedure will likely result in sign...
Source: Trials - July 11, 2018 Category: Research Source Type: clinical trials

Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial
Cardiovascular disease is the leading cause of morbidity and mortality in the world, including China. Cardiac rehabilitation (CR) has been demonstrated to be beneficial in reducing cardiovascular mortality, my... (Source: Trials)
Source: Trials - July 9, 2018 Category: General Medicine Authors: Richard Y. Cao, Hongchao Zheng, Qiongyao Mi, Qing Li, Wenchao Yuan, Yueyou Ding and Jian Yang Tags: Study protocol Source Type: research

The impact of an exercise training intervention on cortisol levels and post-traumatic stress disorder in juveniles from an Ugandan refugee settlement: study protocol for a randomized control trial
Latest research demonstrates a significant improvement in stress-related symptoms in psychological disorders as a result of exercise training (ET). Controlled clinical trials further validate the significance ... (Source: Trials)
Source: Trials - July 9, 2018 Category: General Medicine Authors: Henning Budde, Davin P. Akko, Herbert E. Ainamani, Eric Murillo-Rodr íguez and Roland Weierstall Tags: Study protocol Source Type: research

The impact of an exercise training intervention on cortisol levels and post-traumatic stress disorder in juveniles from an Ugandan refugee settlement: study protocol for a randomized control trial
DiscussionTo date, there is no controlled and reliable longitudinal study examining the effects of an ET program on symptom severity in individuals with PTSD that can be explained with a harmonization of cortisol secretion. The presented study design introduces an intervention that can be implemented with little expenditure. It aims to provide a promising low-threshold and cost-effective treatment approach for the application in resource-poor settings.Trial registrationGerman Trials Register, ID:DRKS00014280. Registered prospectively on 15 March 2018. (Source: Trials)
Source: Trials - July 9, 2018 Category: Research Source Type: clinical trials

Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial
This study is a single-center, pilot, randomized, controlled study that is currently being carried out at a regional hospital in Shanghai. Forty patients with CHD who underwent percutaneous coronary intervention will be randomly allocated into either the intervention group or control group. Participants in the intervention group will undergo 8  weeks of aerobic exercise with targeted intensity and participants in the control group will undergo 8 weeks of leisure exercise. The primary measurement is the feasibility of the trial; the secondary measurement is the capacity of aerobic metabolism and the exploratory me...
Source: Trials - July 9, 2018 Category: Research Source Type: clinical trials