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Treating prolonged grief disorder with prolonged grief-specific cognitive behavioral therapy: study protocol for a randomized controlled trial
DiscussionThe trial is designed to avoid bias as much as possible (stratified randomization performed independently, blinded outcome assessment, intention-to-treat-analysis, balanced treatment dose, continuous supervision, control for allegiance effects) thereby enhancing internal validity. At the same time, some aspects of the trial will ensure clinical relevance (recruiting at outpatient clinics that are part of routine health care and keeping exclusion criteria to a minimum). Since the trial is powered adequately for the primary outcome, all secondary analyses including moderator analyses are exploratory by nature. The ...
Source: Trials - April 20, 2018 Category: Research Source Type: clinical trials

Does sensorimotor upper limb therapy post stroke alter behavior and brain connectivity differently compared to motor therapy? Protocol of a phase II randomized controlled trial
DiscussionThe integration of sensory and motor rehabilitation into one therapy model might provide the added value of this therapy to improve sensorimotor performance post stroke. Insight in the behavioral and brain connectivity changes post therapy will lead to a better understanding of working mechanisms of therapy and will provide new knowledge for patient-tailored therapy approaches.Trial registrationClinicalTrials.gov,NCT03236376. Registered on 8 August 2017. (Source: Trials)
Source: Trials - April 20, 2018 Category: Research Source Type: clinical trials

Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial
Deep dermal burns require tangential excision of non-viable tissue and skin grafting to improve wound healing and burn-scar quality. Tangential excision is conventionally performed with a knife, but during the... (Source: Trials)
Source: Trials - April 19, 2018 Category: General Medicine Authors: Catherine M. Legemate, Harold Goei, Esther Middelkoop, Irma M. M. H. Oen, Tim H. J. Nijhuis, Kelly A. A. Kwa, Paul P. M. van Zuijlen, Gerard I. J. M. Beerthuizen, Marianne K. Nieuwenhuis, Margriet E. van Baar and Cornelis H. van der Vlies Tags: Study protocol Source Type: research

Stages of behavioural change after direct-to-consumer disease risk profiling: study protocol of two integrated controlled pragmatic trials
The incidence and prevalence of chronic diseases have reached epidemic proportions during the last decades and are not expected to diminish. Chronic diseases increasingly affect younger individuals too, with o... (Source: Trials)
Source: Trials - April 19, 2018 Category: General Medicine Authors: Kelly F. J. Stewart, Anke Wesselius, Annemie M. W. J. Schols and Maurice P. Zeegers Tags: Study protocol Source Type: research

Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services
We have previously proposed that trials of social interventions can be done within a “realist” research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our... (Source: Trials)
Source: Trials - April 19, 2018 Category: General Medicine Authors: Chris Bonell, Graham Moore, Emily Warren and Laurence Moore Tags: Methodology Source Type: research

Mobile Link – a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial
In Cambodia, HIV prevalence is concentrated in key populations including among female entertainment workers (FEWs) who may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive heal... (Source: Trials)
Source: Trials - April 19, 2018 Category: General Medicine Authors: Carinne Brody, Sovannary Tuot, Pheak Chhoun, Dallas Swendenman, Kathryn C. Kaplan and Siyan Yi Tags: Study protocol Source Type: research

Parenting Resilient Kids (PaRK), an online parenting program to prevent anxiety and depression problems in primary school-aged children: Study protocol for a randomised controlled trial
Preventive efforts targeting childhood anxiety and depression symptoms have the potential to alter the developmental trajectory of depression and anxiety disorders across the lifespan. Substantial previous res... (Source: Trials)
Source: Trials - April 19, 2018 Category: General Medicine Authors: Luwishennadige Madhawee N. Fernando, Wan Hua Sim, Anthony F. Jorm, Ron Rapee, Katherine A. Lawrence and Marie B. H. Yap Tags: Study protocol Source Type: research

Erythropoietin as an add-on treatment for cognitive side effects of electroconvulsive therapy: a study protocol for a randomized controlled trial
DiscussionIf EPO is found to reduce the cognitive side effects of ECT, this could have important implications for future treatment strategies for depression and for the scientific understanding of the neurobiological etiology of cognitive dysfunction in patients treated with ECT.Trial registrationClinicalTrials.gov,NCT03339596. Registered on 10 November 2017. (Source: Trials)
Source: Trials - April 19, 2018 Category: Research Source Type: clinical trials

Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial
DiscussionAlthough recent trials of TB treatment-shortening in adults with sputum-positivity have not been successful, the question has never been addressed in children, who have mainly paucibacillary, non-severe smear-negative disease. SHINE should inform whether treatment-shortening of drug-susceptible TB in children, regardless of HIV status, is efficacious and safe. The trial will also fill existing gaps in knowledge on dosing and acceptability of new anti-tuberculosis formulations and commonly used HIV drugs in settings with a high burden of TB. A positive result from this trial could simplify and shorten treatment, i...
Source: Trials - April 19, 2018 Category: Research Source Type: clinical trials

Parenting Resilient Kids (PaRK), an online parenting program to prevent anxiety and depression problems in primary school-aged children: Study protocol for a randomised controlled trial
DiscussionThis randomised controlled trial will examine the efficacy of the Parenting Resilient Kids program as a preventive intervention for anxiety and depression symptoms in primary school-aged children, as well as changes in child and parent health-related quality of life. Findings from this study will examine design features that render web-based prevention programs effective and the extent to which parents can be engaged and motivated to change through a minimally guided parenting program.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): Trial IDACTRN12616000621415 Registered on 13 May 2016....
Source: Trials - April 19, 2018 Category: Research Source Type: clinical trials

Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services
ConclusionWe conclude that the most appropriate paradigm for RCTs of social interventions is realism not positivism. (Source: Trials)
Source: Trials - April 19, 2018 Category: Research Source Type: clinical trials

Stages of behavioural change after direct-to-consumer disease risk profiling: study protocol of two integrated controlled pragmatic trials
DiscussionThis research can provide valuable insights into the effectiveness of and possible ways forward in the field of personalised prevention making use of lifestyle interventions enriched with modern genetic advancements.Trial registrationNederlands Trial Register,NTR6289 andNTR6288. Registered on 24 February 2017. (Source: Trials)
Source: Trials - April 19, 2018 Category: Research Source Type: clinical trials

Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial
This study will contribute to the optimal surgical treatment of patients with deep dermal burn wounds.Trial registrationDutch Trial Register,NTR6232. Registered on 23 January 2017. (Source: Trials)
Source: Trials - April 19, 2018 Category: Research Source Type: clinical trials

Mobile Link – a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial
This article describes study design and implementation of a randomized controlled trial (RCT) of a mobile health intervention (theMobile Link) aiming to improve SRH and related outcomes among FEWs in Cambodia.MethodsA two-arm RCT will be used to determine the effectiveness of a mobile-phone-based text/voice messaging intervention. The intervention will be developed through a participatory process. Focus group discussions and in-depth interviews have been conducted to inform and tailor behavior change theory-based text and voice messages. During the implementation phase, 600 FEWs will be recruited and randomly assigned into...
Source: Trials - April 19, 2018 Category: Research Source Type: clinical trials

CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial
Mesothelioma is an incurable, apoptosis-resistant cancer caused in most cases by previous exposure to asbestos and is increasing in incidence. It represents a growing health burden but remains under-researched... (Source: Trials)
Source: Trials - April 18, 2018 Category: General Medicine Authors: Dean A. Fennell, Emma Kirkpatrick, Kelly Cozens, Mavis Nye, Jason Lester, Gerard Hanna, Nicola Steele, Peter Szlosarek, Sarah Danson, Joanne Lord, Christian Ottensmeier, Daniel Barnes, Stephanie Hill, Mihalis Kalevras, Tom Maishman and Gareth Griffiths Tags: Study protocol Source Type: research

CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial
DiscussionThe outcome of this trial will provide evidence of the potential benefit of the use of nivolumab in the treatment of relapsed mesothelioma. If found to be clinically effective, safe and cost-effective it is likely to become the new standard of care in the UK.Trial registrationEudraCT Number: 2016 –003111-35 (entered on 21 July 2016); ClinicalTrials.gov, ID:NCT03063450. Registered on 24 February 2017. (Source: Trials)
Source: Trials - April 18, 2018 Category: Research Source Type: clinical trials

Implementation of telemedicine for knee osteoarthritis: study protocol for a randomized controlled trial
Osteoarthritis (OA) is the most prevalent chronic joint disease, characterized by joint structural deterioration, pain and loss of function among the elders. It is also associated with several extra-articular ... (Source: Trials)
Source: Trials - April 17, 2018 Category: General Medicine Authors: Zhengping Huang, Xia Pan, Weiming Deng, Zhixiang Huang, Yukai Huang, Xuechan Huang, Zhaohua Zhu, Weiyu Han, Shaoling Zheng, Xin Guo, Changhai Ding and Tianwang Li Tags: Study protocol Source Type: research

Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial
Renal transplantation represents the treatment of choice of end-stage kidney disease. Delayed graft function (DGF) remains the most frequent complication after this procedure, reaching more than 30%. Its preve... (Source: Trials)
Source: Trials - April 17, 2018 Category: General Medicine Authors: Jean-Christophe Orban, Eric Fontaine, Elisabeth Cassuto, Karine Baumstarck, Marc Leone, Jean-Michel Constantin and Carole Ichai Tags: Study protocol Source Type: research

A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial
DiscussionREACT represents the first large-scale, pragmatic, community-based trial in the UK to target the non-disabled but high-risk segment of the older population with an intervention to reduce mobility-related disability. A programme that can successfully engage this population in sufficient activity to improve strength, aerobic capacity, coordination and balance would have a major impact on sustaining health and independence.REACT is also the first study of its kind to conduct a full economic and comprehensive process evaluation alongside the RCT. If effective and cost-effective, the REACT intervention has strong pote...
Source: Trials - April 17, 2018 Category: Research Source Type: clinical trials

Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial
DiscussionIf the addition of calcitriol to RAAS inhibition with ACEI or ARB safely results in a significant reduction in albuminuria, the study adds to the body of evidence supporting a role for vitamin D in reno-protection, will inform clinical practice and could result in significant reduction of healthcare costs associated with DKD.Trial registrationISRCTN,ISRCTN86739609. Registered on 7 June 2017. ClinicalTrials.gov,NCT03216564. Registered on 13 July 2017. (Source: Trials)
Source: Trials - April 17, 2018 Category: Research Source Type: clinical trials

Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial
DiscussionDelayed graft function is a major issue after renal transplantation, impeding long-term prognosis. Cyclosporine A pretreatment in deceased donors could improve the outcome of patients after renal transplantation.Trial registrationClinicalTrials.gov, ID:NCT02907554 Registered on 20 September 2016.   (Source: Trials)
Source: Trials - April 17, 2018 Category: Research Source Type: clinical trials

SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial
This study is a single-blinded pilot randomized controlled trial (RCT) with two treatment arms. The participants will be randomly assigned either to sensory re-learning in combination with task-specific training (sensory group) or to task-specific training only (control group). The training will consist of 2.5  h of group training per session, 2 times per week for 5 weeks. The primary outcome measures to assess sensory function are as follows: Semmes-Weinstein monofilament, Shape/Texture Identification (STI™) test, Fugl-Meyer Assessment—upper extremity (FMA-UE; sensory section), and tactile object i d...
Source: Trials - April 17, 2018 Category: Research Source Type: clinical trials

Implementation of telemedicine for knee osteoarthritis: study protocol for a randomized controlled trial
DiscussionThis trial is intended to test the application of GOHT in the chronic management in knee OA. The hypothesis is that OA patients may receive disease management via this network platform conveniently and effectively, especially those in the remote areas of our country. GOHT telemedicine would be an attractive alternative to traditional methods for disease management in knee OA. The results could provide preliminary experiences and guidance for an upcoming full-scale randomized controlled trial (RCT) in disease management via telemedicine.Trial registrationChiCTR:ChiCTR1800014465. Registered on 16 January 2018. (Source: Trials)
Source: Trials - April 17, 2018 Category: Research Source Type: clinical trials

SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial
Many stroke survivors suffer from sensory impairments of their affected upper limb (UL). Although such impairments can affect the ability to use the UL in everyday activities, very little attention is paid to ... (Source: Trials)
Source: Trials - April 17, 2018 Category: General Medicine Authors: H åkan Carlsson, Birgitta Rosén, Hélène Pessah-Rasmussen, Anders Björkman and Christina Brogårdh Tags: Study protocol Source Type: research

Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial
The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. T2DM is associated with serious macro- and microvascular complications. In particular, diabetic kidney disease (DKD), which begins wit... (Source: Trials)
Source: Trials - April 17, 2018 Category: General Medicine Authors: Shahrad Taheri, Muhammad Asim, Hassan al Malki, Omar Fituri, Manikkam Suthanthiran and Phyllis August Tags: Study protocol Source Type: research

A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial
The REtirement in ACTion (REACT) study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial (RCT) with an internal pilot phase. It aims to test the effectiveness and cost-effective... (Source: Trials)
Source: Trials - April 17, 2018 Category: General Medicine Authors: Afroditi Stathi, Janet Withall, Colin J. Greaves, Janice L. Thompson, Gordon Taylor, Antonieta Medina-Lara, Colin Green, James Bilzon, Selena Gray, Heidi Johansen-Berg, Claire E. Sexton, Max J. Western, Jolanthe L. de Koning, Jessica C. Bollen, Sarah J. M Tags: Study protocol Source Type: research

Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomized controlled equivalence trial of 125 mm versus 150 mm Exeter V40 stems in total hip arthroplasty
The use of shorter length femoral stems during total hip arthroplasty has been suggested to accommodate wider patient femoral geometry and offer maximal bone preservation. However, cemented short-stem designs ... (Source: Trials)
Source: Trials - April 16, 2018 Category: General Medicine Authors: David F. Hamilton, Nicholas E. Ohly and Paul Gaston Tags: Study protocol Source Type: research

ENdometrial cancer SURvivors ’ follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial
It has often been hypothesized that the frequency of follow-up visits for patients with early-stage endometrial cancer could be decreased. However, studies evaluating effects of a reduced follow-up schedule am... (Source: Trials)
Source: Trials - April 16, 2018 Category: General Medicine Authors: Nicole P. M. Ezendam, Belle H. de Rooij, Roy F. P. M. Kruitwagen, Carien L. Creutzberg, Ingrid van Loon, Dorry Boll, M. Caroline Vos and Lonneke V. van de Poll-Franse Tags: Study protocol Source Type: research

ENdometrial cancer SURvivors ’ follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial
DiscussionWe anticipate that patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower healthcare use and costs than patients in the control arm. No differences are expected in quality-adjusted life-years and satisfaction, but the reduced schedule is expected to be cost-saving when implemented in the Netherlands.Trial registrationClinicalTrials.gov,NCT02413606. Registered on 10 April 2015. (Source: Trials)
Source: Trials - April 16, 2018 Category: Research Source Type: clinical trials

Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomized controlled equivalence trial of 125  mm versus 150 mm Exeter V40 stems in total hip arthroplasty
DiscussionStem length may be associated with outcome; however, we can find no randomised trial in which researchers investigated the effect of stem length on patient outcome following cemented total hip arthroplasty. The aim of this trial is to determine if the use of short cemented stems offers equivalent patient outcomes to those achieved following surgery with standard length stems.Trial registrationInternational Standard Randomised Controlled Trial Number,ISRCTN13154542, Registered on 30 June 2017. (Source: Trials)
Source: Trials - April 16, 2018 Category: Research Source Type: clinical trials

Mecasin treatment in patients with amyotrophic lateral sclerosis: study protocol for a randomized controlled trial
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that causes paralysis of limb, swallowing, and breathing muscles. Riluzole, the Food and Drug Administration-approved drug for ALS, prov... (Source: Trials)
Source: Trials - April 13, 2018 Category: General Medicine Authors: Sungha Kim, Jae Kyoun Kim, Mi Ju Son, Dongwoung Kim, Bongkeun Song, Ilhong Son, Hyung Won Kang, Jongdeok Lee and Sungchul Kim Tags: Study protocol Source Type: research

Effectiveness of school dental screening on dental visits and untreated caries among primary schoolchildren: study protocol for a cluster randomised controlled trial
Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. School-based dental screening could be a potential intervention that impact... (Source: Trials)
Source: Trials - April 13, 2018 Category: General Medicine Authors: Haya Alayadi, Wael Sabbah and Eduardo Bernab é Tags: Study protocol Source Type: research

Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial
People with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant... (Source: Trials)
Source: Trials - April 13, 2018 Category: General Medicine Authors: Lahiru Russell, Anna Ugalde, Donna Milne, Meinir Krishnasamy, Eric O (Seung Chul), David W Austin, Richard Chambers, Liliana Orellana and Patricia M Livingston Tags: Study protocol Source Type: research

Mecasin treatment in patients with amyotrophic lateral sclerosis: study protocol for a randomized controlled trial
DiscussionThis trial will aim to identify the optimal dosage of Mecasin. Additionally, it will test the efficacy and safety of Mecasin in conjunction with standard treatment, riluzole, for alleviating the functional decline in patients with ALS.Trial registrationKorean National Clinical Trial Registry CRIS;KCT0001984. Registered on 28 July 2016. (Source: Trials)
Source: Trials - April 13, 2018 Category: Research Source Type: clinical trials

Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial
This study aims to (1) examine whether individuals with a melanoma diagnosis are willing to participate and adhere to a 6-week online mindfulness-based intervention and (2) explore potential benefits of the program on fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness to inform the design of a clinical trial.Methods/designThis is a single-site randomised controlled trial of a feasibility study. Seventy-five participants with stage 2c or 3 melanoma will be recruited from a melanoma outpatient clinic and randomised (2:1) either to an online mindfulness-based program (intervention) or to us...
Source: Trials - April 13, 2018 Category: Research Source Type: clinical trials

Effectiveness of school dental screening on dental visits and untreated caries among primary schoolchildren: study protocol for a cluster randomised controlled trial
DiscussionThis project should provide high level of evidence on the clinical benefits of school dental screening. The findings should potentially inform policies related to the continuation/implementation of school-based dental screening in Saudi Arabia.Trial registrationClinicalTrials.gov, ID:NCT03345680. Registered on 17 November 2017. (Source: Trials)
Source: Trials - April 13, 2018 Category: Research Source Type: clinical trials

Open-label, randomized multicentre phase II study to assess the efficacy and tolerability of sunitinib by dose administration regimen (dose modification or dose interruptions) in patients with advanced or metastatic renal cell carcinoma: study protocol of the SURF trial
Sunitinib is a tyrosine kinase inhibitor approved in the first-line metastatic renal cell carcinoma (MRCC) setting at the dose of 50 mg daily for 4 weeks followed by a pause of 2 weeks. Due to toxicity, this s... (Source: Trials)
Source: Trials - April 12, 2018 Category: General Medicine Authors: Guillaume Mouillet, Marie-Justine Paillard, Tristan Maurina, Dewi Vernerey, Thierry Nguyen Tan Hon, Hamadi Almotlak, Ulrich Stein, Fabien Calcagno, Diane Berthod, Elise Robert, Aurelia Meurisse and Antoine Thiery-Vuillemin Tags: Study protocol Source Type: research

COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial
Proximal femur fractures are a common injury after low energy trauma in the elderly. Most rehabilitation programs are based on restoring mobility and early resumption of weight-bearing. However, therapy compli... (Source: Trials)
Source: Trials - April 12, 2018 Category: General Medicine Authors: Marco Raaben, Syaiful Redzwan, Robin Augustine and Taco Johan Blokhuis Tags: Study protocol Source Type: research

Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage
The purpose of this study is to evaluate whether wrapping of the pedicled falciform ligamentum flap around the gastroduodenal artery (GDA) stump/hepatic artery can significantly decrease the incidence of erosi... (Source: Trials)
Source: Trials - April 12, 2018 Category: General Medicine Authors: Benjamin M üssle, Leonie Zühlke, Ann Wierick, Dorothée Sturm, Xina Grählert, Marius Distler, Nuh N. Rahbari, Jürgen Weitz and Thilo Welsch Tags: Study protocol Source Type: research

Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage
DiscussionOnly few retrospective studies investigated the effectiveness of a falciform ligament wrap around the GDA for prevention of erosion hemorrhage. Erosion hemorrhage occurs in up to 6 –9% of cases after PD and is most frequently evoked by a POPF. Erosion hemorrhage is associated with a remarkable mortality of over 30%. The rate of hemorrhage after performing the wrap is reported to be low. However, there exist no prospectively controlled data to support its general use. Therefo re, the presented randomized controlled trial will provide clinically relevant evidence of the effectiveness of the wrap with statisti...
Source: Trials - April 12, 2018 Category: Research Source Type: clinical trials

COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial
DiscussionThe first aim of this multicenter trial is to investigate the normal gait patterns after proximal femur fractures in the elderly. The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; therefore, the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly. This could lead to improved outcome. In addition, analysis of the population may indicate characteristics of subgroups that benefit from feedback, making a differentiated approach in rehabilitation strategy possible.Trial registrationT...
Source: Trials - April 12, 2018 Category: Research Source Type: clinical trials

Open-label, randomized multicentre phase II study to assess the efficacy and tolerability of sunitinib by dose administration regimen (dose modification or dose interruptions) in patients with advanced or metastatic renal cell carcinoma: study protocol of the SURF trial
This article displays the key elements of the study protocol.Methods/designSURF [NCT02689167] is a prospective, randomized, open-label phase IIb study. Patients are included at sunitinib initiation while receiving standard schedule 4/2 (50  mg daily) according to the marketing authorization indication. When a dose adjustment of sunitinib is required, patients are randomized between standard schedule 4/2 (37.5 mg daily) and experimental schedule 2/1 (50 mg daily). Key eligibility criteria are the following: patients with locally adv anced inoperable or MRCC who are starting first-line treatment with sunitinib...
Source: Trials - April 12, 2018 Category: Research Source Type: clinical trials

Is treatment outcome improved if patients match themselves to treatment options? Study protocol for a randomized controlled trial
Research on matching patients to treatment has shown that matching grounded in expert views is little better than allocating patients by chance. Furthermore, there is growing emphasis on involving patients in ... (Source: Trials)
Source: Trials - April 6, 2018 Category: General Medicine Authors: Morten Ellegaard Hell, William R. Miller, Bent Nielsen and Anette S øgaard Nielsen Tags: Study protocol Source Type: research

Is treatment outcome improved if patients match themselves to treatment options? Study protocol for a randomized controlled trial
This study will cast light on this issue by focusing on patients ’ choice and thereby clarifying if patients’ perceived autonomy yields better outcomes.Trial registrationClinicalTrials.gov,NCT03278821. Registered on 12 September 2017. (Source: Trials)
Source: Trials - April 6, 2018 Category: Research Source Type: clinical trials

A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial
Latino men who have sex with men (MSM) experienced a 13% increase in HIV diagnoses from 2010 to 2014, more than any other racial/ethnic subgroup of MSM in the United States. If current HIV diagnoses rates pers... (Source: Trials)
Source: Trials - April 5, 2018 Category: General Medicine Authors: Omar Martinez, M. Isabel Fernandez, Elwin Wu, Alex Carballo-Di éguez, Guillermo Prado, Adam Davey, Ethan Levine, Brian Mattera, Nikki Lopez, Omar Valentin, Ashley Murray and Madeline Sutton Tags: Study protocol Source Type: research

A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial
DiscussionThis paper describes an innovative RCT that incorporates multiple HIV prevention techniques for Latino MSM in couples, regardless of serostatus. The ongoing involvement of community stakeholders, members of the target population, and a community advisory board is emphasized, and plans for widespread dissemination and application of findings into practice are discussed.Trial registrationTrial registration:NCT03048838. Registered on 3 February 2017. (Source: Trials)
Source: Trials - April 5, 2018 Category: Research Source Type: clinical trials

Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial
Ventilator-associated respiratory infection (VARI) comprises ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT). Although their diagnostic criteria vary, together these are... (Source: Trials)
Source: Trials - April 4, 2018 Category: General Medicine Authors: Vu Quoc Dat, Ronald B. Geskus, Marcel Wolbers, Huynh Thi Loan, Lam Minh Yen, Nguyen Thien Binh, Le Thanh Chien, Nguyen Thi Hoang Mai, Nguyen Hoan Phu, Nguyen Phu Huong Lan, Nguyen Van Hao, Hoang Bao Long, Tran Phuong Thuy, Nguyen Van Kinh, Nguyen Vu Trung Tags: Study protocol Source Type: research

Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial
This study will provide high-quality evidence concerning the use of continuous endotracheal cuff pressure control as a method to reduce VARI, antibiotic use and hospitalisation costs and to shorten stay.Trial registrationClinicalTrials.gov,NCT02966392. Registered on November 9, 2016. Protocol version: 2.0; issue date March 3, 2017. (Source: Trials)
Source: Trials - April 4, 2018 Category: Research Source Type: clinical trials

A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial
The clinical benefit of early colonoscopy within 24 h of arrival in patients with severe acute lower gastrointestinal bleeding (ALGIB) remains controversial. This trial will compare early colonoscopy (performe... (Source: Trials)
Source: Trials - April 3, 2018 Category: General Medicine Authors: Ryota Niikura, Naoyoshi Nagata, Atsuo Yamada, Hisashi Doyama, Yasutoshi Shiratori, Tsutomu Nishida, Shu Kiyotoki, Tomoyuki Yada, Tomoki Fujita, Tetsuya Sumiyoshi, Kenkei Hasatani, Tatsuya Mikami, Tetsuro Honda, Katsuhiro Mabe, Kazuo Hara, Katsumi Yamamoto Tags: Study protocol Source Type: research

Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial
Anxiety and depression are prevalent among cardiac rehabilitation patients but pharmacological and psychological treatments have limited effectiveness in this group. Furthermore, psychological interventions ha... (Source: Trials)
Source: Trials - April 3, 2018 Category: General Medicine Authors: Adrian Wells, Kirsten McNicol, David Reeves, Peter Salmon, Linda Davies, Anthony Heagerty, Patrick Doherty, Rebecca McPhillips, Rebecca Anderson, Cintia Faija, Lora Capobianco, Helen Morley, Hannah Gaffney, Gemma Shields and Peter Fisher Tags: Study protocol Source Type: research