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

WASH Benefits Bangladesh trial: system for monitoring coverage and quality in an efficacy trial
Researchers typically report more on the impact of public health interventions and less on the degree to which interventions were followed implementation fidelity. We developed and measured fidelity indicators... (Source: Trials)
Source: Trials - July 6, 2018 Category: General Medicine Authors: Mahbubur Rahman, Sania Ashraf, Leanne Unicomb, A. K. M. Mainuddin, Sarker Masud Parvez, Farzana Begum, Kishor Kumar Das, Abu Mohd. Naser, Faruqe Hussain, Thomas Clasen, Stephen P. Luby, Elli Leontsini and Peter J. Winch Tags: Research Source Type: research

Comparison of cold and hot snaring polypectomy for small colorectal polyps: study protocol for a randomized controlled trial
Colorectal cancer remains a considerable challenge in healthcare nowadays. Most patients ’ disease develops via the adenoma–carcinoma sequence; colonoscopy with polypectomy effectively reduces both mortality an... (Source: Trials)
Source: Trials - July 6, 2018 Category: General Medicine Authors: Yen-Nien Chen, Li-Chun Chang, Chi-Yang Chang, Peng-Jen Chen, Chi-Yi Chen, Cheng-Hao Tseng and Han-Mo Chiu Tags: Study protocol Source Type: research

Achieving optimal technology and behavioral uptake of single and combined interventions of water, sanitation hygiene and nutrition, in an efficacy trial (WASH benefits) in rural Bangladesh
Uptake matters for evaluating the health impact of water, sanitation and hygiene (WASH) interventions. Many large-scale WASH interventions have been plagued by low uptake. For the WASH Benefits Bangladesh effi... (Source: Trials)
Source: Trials - July 6, 2018 Category: General Medicine Authors: Sarker Masud Parvez, Rashidul Azad, Mahbubur Rahman, Leanne Unicomb, Pavani K. Ram, Abu Mohd Naser, Christine P. Stewart, Kaniz Jannat, Musarrat Jabeen Rahman, Elli Leontsini, Peter J. Winch and Stephen P. Luby Tags: Research Source Type: research

WASH Benefits Bangladesh trial: management structure for achieving high coverage in an efficacy trial
Water, sanitation, and hygiene (WASH) efficacy trials deliver interventions to the target population under optimal conditions to estimate their effects on outcomes of interest, to inform subsequent selection f... (Source: Trials)
Source: Trials - July 6, 2018 Category: General Medicine Authors: Leanne Unicomb, Farzana Begum, Elli Leontsini, Mahbubur Rahman, Sania Ashraf, Abu Mohd Naser, Fosiul A. Nizame, Kaniz Jannat, Faruqe Hussain, Sarker Masud Parvez, Shaila Arman, Moshammot Mobashara, Stephen P. Luby and Peter J. Winch Tags: Research Source Type: research

Effects of hemodynamic monitoring using a single-use transesophageal echocardiography probe in critically ill patients – study protocol for a randomized controlled trial
Hemodynamic instability is one of the leading causes of intensive care unit (ICU) admission. Early stabilization of hemodynamics is associated with improved outcome. The monitoring used to guide hemodynamic su... (Source: Trials)
Source: Trials - July 6, 2018 Category: General Medicine Authors: Luca Cioccari, Bjoern Zante, Andreas Bloch, David Berger, Andreas Limacher, Stephan M. Jakob, Jukka Takala and Tobias M. Merz Tags: Study protocol Source Type: research

Effects of hemodynamic monitoring using a single-use transesophageal echocardiography probe in critically ill patients – study protocol for a randomized controlled trial
DiscussionThe effect of using echocardiography as a monitoring modality on relevant patient outcomes has not been established so far. The study at hand may be one of the first trials to provide detailed data on effectiveness and safety of echocardiography to guide treatment in patients with circulatory shock.Trial registrationClinicalTrials.gov, ID:NCT02048566. Registered on January 29, 2014.   (Source: Trials)
Source: Trials - July 6, 2018 Category: Research Source Type: clinical trials

Comparison of cold and hot snaring polypectomy for small colorectal polyps: study protocol for a randomized controlled trial
AbstractBackgroundColorectal cancer remains a considerable challenge in healthcare nowadays. Most patients ’ disease develops via the adenoma–carcinoma sequence; colonoscopy with polypectomy effectively reduces both mortality and incidence by removing precancerous adenomas. Previous studies showed that polypectomy without electrocautery (cold snaring polypectomy) is a safe and time-saving procedure t o manage polyps
Source: Trials - July 6, 2018 Category: Research Source Type: clinical trials

WASH Benefits Bangladesh trial: management structure for achieving high coverage in an efficacy trial
ConclusionsThe intensive intervention delivery system required for an efficacy trial differs in many respects from the system for a routine program. To implement a routine program at scale requires further research on how to optimize the supervisor-to-CHW-to-intervention household ratios, as well as other program costs without compromising program effectiveness.Trial registrationClinicalTrials.gov, ID:NCC01590095. Registered on 2 May 2012. (Source: Trials)
Source: Trials - July 6, 2018 Category: Research Source Type: clinical trials

Achieving optimal technology and behavioral uptake of single and combined interventions of water, sanitation hygiene and nutrition, in an efficacy trial (WASH benefits) in rural Bangladesh
ConclusionsRigorous implementation of interventions deployed at large scale in the context of an efficacy trial achieved high levels of technology and behavioral uptake in individual and combined WASH and nutrition intervention households. Further work should assess how to achieve similar uptake levels under programmatic conditions.Trial registrationWASH Benefits Bangladesh: ClinicalTrials.gov, identifier:NCT01590095. Registered on April 30, 2012. (Source: Trials)
Source: Trials - July 6, 2018 Category: Research Source Type: clinical trials

WASH Benefits Bangladesh trial: system for monitoring coverage and quality in an efficacy trial
ConclusionsAn intensive implementation fidelity monitoring and rapid response system proved beneficial for this efficacy trial. To implement a routine program at scale requires further research into an adaptation of fidelity monitoring that supports program effectiveness.Trial registrationWASH Benefits Bangladesh: ClinicalTrials.gov, ID:NCT01590095. Registered on 30 April 2012. (Source: Trials)
Source: Trials - July 6, 2018 Category: Research Source Type: clinical trials

Open-label randomized controlled trial to compare wound dressings for patients undergoing hip and knee arthroplasty: study protocol for a randomized controlled trial
DiscussionThe results of this study will be useful for clinical decision making by giving information on the contribution of the dressings studied to the outcome of the wound and may also show which dressing offers better results depending on the characteristics of patients.Trial registrationThis trial has been registered at ClinicalTrials.gov (NCT03190447). Retrospectively registered on 16 June 2017. (Source: Trials)
Source: Trials - July 5, 2018 Category: Research Source Type: clinical trials

Open-label randomized controlled trial to compare wound dressings for patients undergoing hip and knee arthroplasty: study protocol for a randomized controlled trial
Surgical wounds are covered to prevent bleeding, absorb the exudates, and provide a barrier against external contamination. Currently, in our hospital, after orthopedic surgery, traditional occlusive dressing ... (Source: Trials)
Source: Trials - July 5, 2018 Category: General Medicine Authors: Maria L ópez-Parra, Dolors Gil-Rey, Esmeralda López-González, Eva-Maria González-Rodríguez, Isabel Simó-Sánchez, Francisco Zamora-Carmona, Lidia Roqueta-Andreu, Marta Arizu-Puigvert, Dolors Abril-Sabater, Àngels Moreno-Álvarez, Àngels López-Bon Tags: Study protocol Source Type: research

Efficacy of Jia Wei Yang He formula as an adjunctive therapy for asthma: study protocol for a randomized, double blinded, controlled trial
In this study, a randomized clinical trial design is described. The results are based on several outcomes that estimate the efficacy of the JWYH formula and prospective links between the airway microbiome and asthma treatment.Trial registrationClinicalTrials.gov, ID:NCT03299322. Registered on 3 October 2017. (Source: Trials)
Source: Trials - July 4, 2018 Category: Research Source Type: clinical trials

Acupuncture as an early treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) patients with flat or high-frequency drop audiograms: study protocol for a randomized controlled trial
This study aims to explore the efficacy and long-term effects of acupuncture in patients with ISSNHL. This study will be a randomized controlled trial with strict methodology and few design deficits. If our study yields positive results, acupuncture could be recommended as a salvage therapy for patients with ISSNHL.Trial registrationChinese Clinical Trial Registry,ChiCTR-ICR-15006787. Registered on 12 July 2015. (Source: Trials)
Source: Trials - July 4, 2018 Category: Research Source Type: clinical trials

The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer ®) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial
Anemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery (including combined coronary artery bypass grafting).... (Source: Trials)
Source: Trials - July 4, 2018 Category: General Medicine Authors: Seung Hyun Lee, Jae-Kwang Shim, Sarah Soh, Jong Wook Song, Byung Chul Chang, Sak Lee and Young-Lan Kwak Tags: Study protocol Source Type: research

The caries-arresting effect of incorporating functionalized tricalcium phosphate into fluoride varnish applied following application of silver nitrate solution in preschool children: study protocol for a randomized, double-blind clinical trial
Dental caries in primary teeth is prevalent, affecting millions of children around the world. Functionalized tricalcium phosphate (fTCP) has been incorporated into sodium fluoride (NaF) varnish to enhance the ... (Source: Trials)
Source: Trials - July 4, 2018 Category: General Medicine Authors: Kitty Jieyi Chen, Sherry Shiqian Gao, Duangporn Duangthip, Edward Chin Man Lo and Chun Hung Chu Tags: Study protocol Source Type: research

Acupuncture as an early treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) patients with flat or high-frequency drop audiograms: study protocol for a randomized controlled trial
Idiopathic sudden sensorineural hearing loss (ISSNHL) is a common form of deafness. Acupuncture has been used as a salvage therapy for ISSNHL in China since 200 BCE. However, the efficacy of acupuncture has no... (Source: Trials)
Source: Trials - July 4, 2018 Category: General Medicine Authors: Kai Shang, Xin Ma, Hui-Lin Liu, Yuan-Yuan Jing, Lin Zeng, Nan Li, De-An Zhou, Jia Wei and Chen Zhang Tags: Study protocol Source Type: research

Safe Birth and Cultural Safety in southern Mexico: study protocol for a randomised controlled trial
Indigenous women in the southern Mexican state of Guerrero face poor maternal health outcomes. Living as they do at the very periphery of the Western health system, they often receive low-quality care from hea... (Source: Trials)
Source: Trials - July 4, 2018 Category: General Medicine Authors: Iv án Sarmiento, Sergio Paredes-Solís, Neil Andersson and Anne Cockcroft Tags: Study protocol Source Type: research

Towards a health-enabling working environment - developing and testing interventions to decrease HIV and TB stigma among healthcare workers in the Free State, South Africa: study protocol for a randomised controlled trial
Occupational exposure to tuberculosis (TB) constitutes a major health risk for healthcare workers (HCWs). The HIV epidemic equally affects the workforce because of the mutually reinforcing epidemiology of HIV ... (Source: Trials)
Source: Trials - July 4, 2018 Category: General Medicine Authors: Asta Rau, Edwin Wouters, Michelle Engelbrecht, Caroline Masquillier, Kerry Uebel, Gladys Kigozi, Nina Sommerland and Andr é Janse van Rensburg Tags: Study protocol Source Type: research

Healthy Campus Trial: a multiphase optimization strategy (MOST) fully factorial trial to optimize the smartphone cognitive behavioral therapy (CBT) app for mental health promotion among university students: study protocol for a randomized controlled trial
DiscussionThe highly efficient experimental design will allow identification of the most effective components and the most efficient combinations thereof among the five components of smartphone CBT for university students. Pragmatically, the findings will help make the most efficacious CBT package accessible to a large number of distressed university students at reduced cost; theoretically, they will shed light on the underlying mechanisms of CBT and help further advance CBT for depression.Trial registrationUMIN,CTR-000031307. Registered on February 14, 2018. (Source: Trials)
Source: Trials - July 4, 2018 Category: Research Source Type: clinical trials

Towards a health-enabling working environment - developing and testing interventions to decrease HIV and TB stigma among healthcare workers in the Free State, South Africa: study protocol for a randomised controlled trial
DiscussionThe study regards as HCWsall staff, working inall different types of jobs, atall levels in the hospitals. Thus, the research addresses HIV and TB stigma across the whole workforce and the entire workplace. In doing so it will (1) generate essential information on stigma among HCWs and (2) implement stigma-reduction interventions that are innovative yet replicable, and potentially beneficial in addressing a pernicious human-rights-based issue.Trial registrationSouth African National Clinical Trials Register, registration ID:DOH-27-1115-5204. Prospectively registered on 26 August 2015. (Source: Trials)
Source: Trials - July 4, 2018 Category: Research Source Type: clinical trials