Multimorbidity risk assessment in adolescents and adults with cerebral palsy: a protocol for establishing a core outcome set for clinical research and practice
DiscussionThis COS will guide clinicians and researchers in assessing multimorbidity risk in adolescents and adults with CP. The inclusion of experts and individuals with CP from international locations for establishing the COS lends strong support to its generalizability. Evidence of its feasibility and approval from all stakeholders will enable implementation in clinical practice, and guide future research using the COS in individuals with CP. (Source: Trials)
Source: Trials - March 19, 2019 Category: Research Source Type: clinical trials

Effects of Lysulin ™ supplementation on pre-diabetes: study protocol for a randomized controlled trial
Diabetes mellitus is rapidly becoming one of the leading causes of morbidity and mortality worldwide. Preventive measures have become important, especially in the South Asian region and other parts of the worl... (Source: Trials)
Source: Trials - March 18, 2019 Category: General Medicine Authors: Priyanga Ranasinghe, Ranil Jayawardena, Lal Chandrasena, Vivianne Noetzel and John Burd Tags: Study protocol Source Type: research

Combined test versus logrank/Cox test in 50 randomised trials
The logrank test and the Cox proportional hazards model are routinely applied in the design and analysis of randomised controlled trials (RCTs) with time-to-event outcomes. Usually, sample size and power calcu... (Source: Trials)
Source: Trials - March 18, 2019 Category: General Medicine Authors: Patrick Royston, Babak Choodari-Oskooei, Mahesh K. B. Parmar and Jennifer K. Rogers Tags: Methodology Source Type: research

Comparing efficacy and safety between Naldebain ® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial
A long-acting prodrug of nalbuphine, nalbuphine sebacate, has been developed for meeting the unmet medical need of long-acting analgesics. Naldebain ® (nalbuphine sebacate) has been developed as a new premedicatio... (Source: Trials)
Source: Trials - March 18, 2019 Category: General Medicine Authors: Hsiang-Lin Tsai, Tsung-Kun Chang, Wei-Chih Su, Yung-Sung Yeh, Ching-Wen Huang, Cheng-Jen Ma and Jaw-Yuan Wang Tags: Study protocol Source Type: research

Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
Generalised anxiety disorder (GAD) is a frequent and severe anxiety disorder among older adults. GAD increases the risk of developing other disorders such as depression and coronary heart disease. Older adults... (Source: Trials)
Source: Trials - March 18, 2019 Category: General Medicine Authors: Silje Haukenes Stavestrand, Kristine Sirev åg, Inger Hilde Nordhus, Trond Sjøbø, Trygve Bruun Endal, Hans M. Nordahl, Karsten Specht, Åsa Hammar, Anne Halmøy, Egil W. Martinsen, Eva Andersson, Helene Hjelmervik, Jan Mohlman, Julian F. Thayer and Ande Tags: Study protocol Source Type: research

Correction to: Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial
After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled. (Source: Trials)
Source: Trials - March 18, 2019 Category: General Medicine Authors: Angelos G. Kolias, Ellie Edlmann, Eric P. Thelin, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z. Al-Tamimi, Daniel Gatt, Simon Thomson, Ian A. Anderson, Oliver Richards, Peter Whitfield, Monica Gherle, Karen Caldwell, Caro Tags: Correction Source Type: research

Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
This study aims to develop better treatment for GAD in older adults. Enhancing treatment response will be valuable from both individual and societal perspectives, especially taking the aging of the general population into account.Trial registrationClinicalTrials.gov,NCT02690441. Registered on 24 February 2016. (Source: Trials)
Source: Trials - March 18, 2019 Category: Research Source Type: clinical trials

Effects of Lysulin ™ supplementation on pre-diabetes: study protocol for a randomized controlled trial
This study will provide the necessary groundwork for future large-scale multicentered clinical trials. The result, positive or negative, should provide a step change in the evidence guiding current and future policies regarding manag ement of pre-diabetes.Trial registrationSri Lanka Clinical Trials Registry,SLCTR/2018/022. Registered on 13 July 2018. Study protocol version 2.0 (23 March 2018). (Source: Trials)
Source: Trials - March 18, 2019 Category: Research Source Type: clinical trials

Comparing efficacy and safety between Naldebain ® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial
This study will demonstrate whether a single use of Naldebain® is not less efficacious than PCA with fentanyl for pain management as a non-inferior trial.Trial registrationNCT03296488. (Source: Trials)
Source: Trials - March 18, 2019 Category: Research Source Type: clinical trials

Correction to: Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial
After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled. (Source: Trials)
Source: Trials - March 18, 2019 Category: Research Source Type: clinical trials

Combined test versus logrank/Cox test in 50 randomised trials
ConclusionsThe evidence for non-PH is checked (and, hence, identified) in only a small minority of RCTs, but non-PH may be present in a substantial fraction of such trials. In our reanalysis of the reconstructed data from 50 trials, the combined test outperformed the Cox test overall. The combined test is a promising approach to making trial design and analysis more robust. (Source: Trials)
Source: Trials - March 18, 2019 Category: Research Source Type: clinical trials

Flexible video endoscope versus Macintosh laryngoscope for orotracheal tracheal intubation in the lateral position: a study protocol for a randomized controlled trial
Tracheal intubation with the patient in the lateral position is difficult because the laryngeal view is compromised during direct laryngoscopy. Flexible video endoscopes may facilitate intubation even when lar... (Source: Trials)
Source: Trials - March 15, 2019 Category: General Medicine Authors: Youguang Gao, Bo Lin, Jinghao Huang, Xianzhong Lin and Caizhu Lin Tags: Study protocol Source Type: research

The effect of repeated remote ischemic postconditioning on infarct size in patients with an ischemic stroke (REPOST): study protocol for a randomized clinical trial
Remote ischemic postconditioning (rIPostC) refers to the observation that repeated, short periods of ischemia protect remote areas against tissue damage during and after prolonged ischemia. Based on previous o... (Source: Trials)
Source: Trials - March 15, 2019 Category: General Medicine Authors: Thijs Landman, Yvonne Schoon, Michiel Warl é, Frank-Erik De Leeuw and Dick Thijssen Tags: Study protocol Source Type: research

Upper limb strength training in subacute stroke patients: study protocol of a randomised controlled trial
Stroke patients are often affected by arm paresis, have functional impairments and receive help from professional or informal caregivers. Progressive resistance training is a common intervention for functional... (Source: Trials)
Source: Trials - March 15, 2019 Category: General Medicine Authors: Susan H ögg, Manfred Holzgraefe, Insa Wingendorf, Jan Mehrholz, Christoph Herrmann and Mark Obermann Tags: Study protocol Source Type: research

Evaluation of repositories for sharing individual-participant data from clinical studies
Data repositories have the potential to play an important role in the effective and safe sharing of individual-participant data (IPD) from clinical studies. We analysed the current landscape of data repositori... (Source: Trials)
Source: Trials - March 15, 2019 Category: General Medicine Authors: Rita Banzi, Steve Canham, Wolfgang Kuchinke, Karmela Krleza-Jeric, Jacques Demotes-Mainard and Christian Ohmann Tags: Review Source Type: research

Application via mechanical dropper alleviates sufentanil-induced cough: a prospective, randomized, single-blinded trial
It was reported that prolonging the injection time or diluting administration can reduce the incidence of opioid-induced cough. However, the incidence of sufentanil-induced cough (SIC) via a standardized infus... (Source: Trials)
Source: Trials - March 15, 2019 Category: General Medicine Authors: Minqiang Liu, Zhichao Li, Song Wang, Yong Liu, Xiangpeng Zhong, Renliang He and Fengxian Li Tags: Research Source Type: research

Effects of transcranial direct current stimulation on the rehabilitation of painful shoulder following a stroke: protocol for a randomized, controlled, double-blind, clinical trial
Shoulder pain is reported to be one of the major challenges faced in the functional recovery of patients in rehabilitation following a stroke. In such cases, transcranial direct current stimulation (tDCS) has ... (Source: Trials)
Source: Trials - March 15, 2019 Category: General Medicine Authors: Janaina Andressa de Souza, Jo ão Carlos Ferrari Corrêa, Letizzia Dall’ Agnol, Filipe Ribeiro dos Santos, Márcia Rafaella Pereira Gomes and Fernanda Ishida Corrêa Tags: Study protocol Source Type: research

Effects of transcranial direct current stimulation on the rehabilitation of painful shoulder following a stroke: protocol for a randomized, controlled, double-blind, clinical trial
AbstractBackgroundShoulder pain is reported to be one of the major challenges faced in the functional recovery of patients in rehabilitation following a stroke. In such cases, transcranial direct current stimulation (tDCS) has been used as an additional therapeutic tool for improvements in central and peripheral pain. The aim of the proposed study is to evaluate the effect of tDCS when combined with upper limb physical therapy on pain intensity and functional improvement in stroke survivors with shoulder pain in the hemiplegic limb.MethodsA randomized, placebo-controlled, double-blind, clinical trial is proposed. The volun...
Source: Trials - March 15, 2019 Category: Research Source Type: clinical trials

Upper limb strength training in subacute stroke patients: study protocol of a randomised controlled trial
This study attempts to close the evidence gap for effects of arm strength training in subacute stroke patients. The results of this trial will provide robust evidence for effects and safety of high-intensity arm training for people with stroke.Trial registrationGerman Clinical Trials Register,DRKS00012484. Registered on 26 May 2017. (Source: Trials)
Source: Trials - March 15, 2019 Category: Research Source Type: clinical trials

Evaluation of repositories for sharing individual-participant data from clinical studies
ConclusionsOur evaluation, though often hampered by the lack of sufficient information, can help researchers to find a suitable repository for their datasets. Some repositories are more mature because of their support for clinical dataset preparation, contractual agreements, metadata and identifiers, different modalities of access, and long-term preservation of data. Further work is now required to achieve a more robust and accurate system for evaluation, which in turn may encourage the sharing of clinical study data.Trial registrationStudy protocol available athttps://zenodo.org/record/1438261#.W64kW9Egrcs. (Source: Trials)
Source: Trials - March 15, 2019 Category: Research Source Type: clinical trials

The effect of repeated remote ischemic postconditioning on infarct size in patients with an ischemic stroke (REPOST): study protocol for a randomized clinical trial
DiscussionPrevious studies in animals and humans, using a single bout of remote ischemic conditioning, report a potential effect of rIPostC in attenuating neural damage. Although repeated rIPostC has been investigated for cardiovascular disease patients and preclinical stroke models, no previous study has explored the potential physiological and clinical effects of repeatedly applying rIPostC during the hospitalization phase after a stroke.Trial registrationNetherlands Trial Register,NTR6880. Registered on 8 December 2017. (Source: Trials)
Source: Trials - March 15, 2019 Category: Research Source Type: clinical trials

Flexible video endoscope versus Macintosh laryngoscope for orotracheal tracheal intubation in the lateral position: a study protocol for a randomized controlled trial
DiscussionThe trial will clarify the efficacy of intubation with a Macintosh laryngoscope and a flexible video endoscope in the lateral position, and whether the two devices could be used in combination to secure the airway in cases where endotracheal intubation in the lateral position has failed with one device.Trial registrationChinese Clinical Trial Register,ChiCTR- IOR-15007175. Registered on 6 October 2015. (Source: Trials)
Source: Trials - March 15, 2019 Category: Research Source Type: clinical trials

Application via mechanical dropper alleviates sufentanil-induced cough: a prospective, randomized, single-blinded trial
ConclusionSufentanil application via mechanical dropper can significantly alleviate the occurrence of SIC during the induction phase of total intravenous general anesthesia. This method is simple, safe, and reliable, and has wide prospective application for clinical use.Trial registrationChinese Clinical Trial Register,ChiCTR-IOR-17011561. Registered on 3 June 2017. (Source: Trials)
Source: Trials - March 15, 2019 Category: Research Source Type: clinical trials

Role of cerebral hypoperfusion in multiple sclerosis (ROCHIMS): study protocol for a proof-of-concept randomized controlled trial with bosentan
Axonal degeneration is related to long-term disability in patients with multiple sclerosis (MS). The underlying mechanism remains ill understood but appears to involve axonal energetic dysfunction. A globally ... (Source: Trials)
Source: Trials - March 14, 2019 Category: General Medicine Authors: St éphanie Hostenbach, Ayla Pauwels, Veronique Michiels, Hubert Raeymaekers, Anne-Marie Van Binst, Annick Van Merhaeghen-Wieleman, Peter Van Schuerbeek, Jacques De Keyser and Miguel D’Haeseleer Tags: Study protocol Source Type: research

Role of cerebral hypoperfusion in multiple sclerosis (ROCHIMS): study protocol for a proof-of-concept randomized controlled trial with bosentan
DiscussionWe hypothesize that restoring cerebral hypoperfusion in MS patients improves axonal metabolism.Early positive effects on fatigue and cognitive dysfunction related to MS might additionally be detected. There is a medical need for drugs that can slow down the progressive axonal degeneration in MS, making this an important topic of interest.Trial registrationClinical Trials Register, EudraCT2017-001253-13. Registered on 15 February 2018. (Source: Trials)
Source: Trials - March 14, 2019 Category: Research Source Type: clinical trials

The effect of manual therapy and exercise on age-related lung function: study protocol for a randomised controlled trial
Ageing is associated with a range of anatomical and physiological changes. Establishing whether a change is part of ‘normal’ ageing or the early signs of disease will affect management strategies. Progressive ... (Source: Trials)
Source: Trials - March 13, 2019 Category: General Medicine Authors: Roger Engel, Sandra Grace and Suzanne Broadbent Tags: Study protocol Source Type: research

The effect of manual therapy and exercise on age-related lung function: study protocol for a randomised controlled trial
DiscussionThis randomised controlled trial is designed to investigate whether manual therapy can mitigate the effects of age-related changes in lung function and whether there is a difference in effect between different forms of manual therapy. This is the first fully powered trial designed to test this hypothesis on healthy males and females in this age range.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR),12616001317482. Registered on 20 September 2016. (Source: Trials)
Source: Trials - March 13, 2019 Category: Research Source Type: clinical trials

Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial
Primary percutaneous coronary intervention (PCI) for patients presenting with acute myocardial infarction (AMI) caused by left main coronary artery occlusion is associated with significantly higher mortality a... (Source: Trials)
Source: Trials - March 8, 2019 Category: General Medicine Authors: Yang Gao, Feng Zhang, Chenguang Li, Yuxiang Dai, Ji ’e Yang, Ya’nan Qu, Juying Qian and Junbo Ge Tags: Study protocol Source Type: research

Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial
DiscussionThe OPTIMAL study is designed to compare the clinical performance of deferred stenting with that of immediate stenting for AMI caused by left main coronary artery occlusion.Trial registrationClinicalTrials.gov Identifier:NCT03282773. Registered on 10 September 2017. (Source: Trials)
Source: Trials - March 8, 2019 Category: Research Source Type: clinical trials

Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT)
Inadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impac... (Source: Trials)
Source: Trials - March 6, 2019 Category: General Medicine Authors: Nancy J. Butcher, Andrea Monsour, Emma J. Mew, Peter Szatmari, Agostino Pierro, Lauren E. Kelly, Mufiza Farid-Kapadia, Alyssandra Chee-a-tow, Leena Saeed, Suneeta Monga, Wendy Ungar, Caroline B. Terwee, Sunita Vohra, Dean Fergusson, Lisa M. Askie, Paula R Tags: Study protocol Source Type: research

Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT)
DiscussionInsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes. (Source: Trials)
Source: Trials - March 6, 2019 Category: Research Source Type: clinical trials

The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study
Assisted vaginal birth is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for assi... (Source: Trials)
Source: Trials - March 5, 2019 Category: General Medicine Authors: Stephen O ’Brien, Emily J. Hotton, Erik Lenguerrand, Julia Wade, Cathy Winter, Tim J. Draycott and Joanna F. Crofts Tags: Study protocol Source Type: research

Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial)
Chronic treatment of hypertension or heart failure very often includes an angiotensin-converting enzyme inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs) as renin-angiotensin system inhibitors (RASi)... (Source: Trials)
Source: Trials - March 5, 2019 Category: General Medicine Authors: Matthieu Legrand, Emmanuel Futier, Marc Leone, Benjamin Deniau, Alexandre Mebazaa, Beno ît Plaud, Pierre Coriat, Patrick Rossignol, Eric Vicaut and Etienne Gayat Tags: Study protocol Source Type: research

Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial)
DiscussionThe results of the trial should provide robust evidence to anesthesiologists and surgeons regarding management of RASi before major non-cardiac surgery.Trial registrationClinicalTrials.gov,NCT03374449. Registered on 11 December 2017. (Source: Trials)
Source: Trials - March 5, 2019 Category: Research Source Type: clinical trials

The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study
DiscussionA future randomised controlled trial of the BD Odon Device versus the current standard instrument (the Kiwi ventouse) is planned. The findings of the ASSIST Study will inform the randomised controlled trial design.Trial registrationISRCTN,ISRCTN10203171. Prospectively registered on 27 July 2018. (Source: Trials)
Source: Trials - March 5, 2019 Category: Research Source Type: clinical trials

Effects of vitamin D supplementation on liver fibrogenic factors in non-alcoholic fatty liver patients with steatohepatitis: study protocol for a randomized clinical trial
It has been suggested that vitamin D and its receptors involve in suppressing fibrogenic signaling in non-alcoholic fatty liver disease (NAFLD). However, the effect of vitamin D supplementation on fibrogenic f... (Source: Trials)
Source: Trials - March 4, 2019 Category: General Medicine Authors: Soraiya Ebrahimpour-Koujan, Amir Ali Sohrabpour, Farshad Foroughi, Ehsan Alvandi and Ahmad Esmaillzadeh Tags: Study protocol Source Type: research

The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial
Stillbirth rates in the United Kingdom (UK) are amongst the highest of all developed nations. The association between small-for-gestational-age (SGA) foetuses and stillbirth is well established, and observatio... (Source: Trials)
Source: Trials - March 4, 2019 Category: General Medicine Authors: Matias C. Vieira, Sophie Relph, Andrew Copas, Andrew Healey, Kirstie Coxon, Alessandro Alagna, Annette Briley, Mark Johnson, Deborah A. Lawlor, Christoph Lees, Neil Marlow, Lesley McCowan, Louise Page, Donald Peebles, Andrew Shennan, Baskaran Thilaganatha Tags: Study protocol Source Type: research

Jin ’s three-needle acupuncture technique for chronic fatigue syndrome: a study protocol for a multicentre, randomized, controlled trial
With an unclear pathomechanism, no confirmed treatment regimen has been established for chronic fatigue syndrome (CFS). Acupuncture is applied as an alternative therapy for CFS. As a kind of acupuncture therap... (Source: Trials)
Source: Trials - March 4, 2019 Category: General Medicine Authors: Wenjia Lin, Xin-lin Chen, Qi Chen, Junmao Wen and Xinghua Chen Tags: Study protocol Source Type: research

Personalized medicine with IgGAM compared with standard of care for treatment of peritonitis after infectious source control (the PEPPER trial): study protocol for a randomized controlled trial
Peritonitis is responsible for thousands of deaths annually in Germany alone. Even source control (SC) and antibiotic treatment often fail to prevent severe sepsis or septic shock, and this situation has hardl... (Source: Trials)
Source: Trials - March 4, 2019 Category: General Medicine Authors: Christina Kalvelage, Kai Zacharowski, Artur Bauhofer, Ulrich Gockel, Michael Adamzik, Axel Nierhaus, Peter Kujath, Christian Eckmann, Mathias W. Pletz, Hendrik Bracht, Tim-Philipp Simon, Michael Winkler, Detlef Kindgen-Milles, Markus Albertsmeier, Markus Tags: Study protocol Source Type: research

Using discrete choice experiments to inform the design of complex interventions
Complex health interventions must incorporate user preferences to maximize their potential effectiveness. Discrete choice experiments (DCEs) quantify the strength of user preferences and identify preference he... (Source: Trials)
Source: Trials - March 4, 2019 Category: General Medicine Authors: Fern Terris-Prestholt, Nyasule Neke, Jonathan M. Grund, Marya Plotkin, Evodius Kuringe, Haika Osaki, Jason J. Ong, Joseph D. Tucker, Gerry Mshana, Hally Mahler, Helen A. Weiss and Mwita Wambura Tags: Methodology Source Type: research

Mental Health Prevention in Preschool Children: study protocol for a feasibility and acceptability randomised controlled trial of a culturally adapted version of the I Can Problem Solve (ICPS) Programme in Chile
DiscussionNo previous studies in Spanish-speaking Latin American countries have been conducted to explore the acceptability and feasibility of ICPS to provide information to evaluate the effectiveness of this intervention on a larger scale.Trial registrationClinicalTrials.gov, ID:NCT03383172. Registered on 26 December 2017. (Source: Trials)
Source: Trials - March 4, 2019 Category: Research Source Type: clinical trials

Using discrete choice experiments to inform the design of complex interventions
We present the process of using a DCE to supplement conventional qualitative formative research in the design of a demand creation intervention for voluntary medical male circumcision (VMMC) to prevent HIV in Tanzania.MethodsThe VMMC intervention was designed within a 3-month formative phase. In-depth interviews (n = 30) and participatory group discussions (n = 20) sought to identify broad setting-specific barriers to and facilitators of VMMC among adult men. Qualitative results informed the DCE development, identifying the role of female partners, service providers’ attitudes and social s...
Source: Trials - March 4, 2019 Category: Research Source Type: clinical trials

The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial
This study will be the first randomised controlled trial examining the clinical efficacy, health economics and implementation of the GAP programme in the antenatal detection of SGA.Methods/designIn this randomised controlled trial, clusters comprising a maternity unit (or National Health Service Trust) were randomised to either implementation of the GAP programme, or standard care. The primary outcome is the rate of antenatal ultrasound detection of SGA in infants found to be SGA at birth by both population and customised standards, as this is recognised as being the group with highest risk for perinatal morbidity and mort...
Source: Trials - March 4, 2019 Category: Research Source Type: clinical trials

Personalized medicine with IgGAM compared with standard of care for treatment of peritonitis after infectious source control (the PEPPER trial): study protocol for a randomized controlled trial
This study aims to combine an assessment of the efficacy of treatment with a pr eparation of human immunoglobulins G, A, and M (IgGAM) with individual status of various biomarkers (immunoglobulin level, procalcitonin, interleukin 6, antigen D-related human leucocyte antigen (HLA-DR), transcription factor NF-κB1, adrenomedullin, and pathogen spectrum).Methods/designA total of 200 patients with sepsis or septic shock will receive standard-of-care treatment  (SoC). Of these, 133 patients (selected by 1:2 randomization) will in addition receive infusions of IgGAM for 5 days. All patients will be followed for ...
Source: Trials - March 4, 2019 Category: Research Source Type: clinical trials

Jin ’s three-needle acupuncture technique for chronic fatigue syndrome: a study protocol for a multicentre, randomized, controlled trial
This study is a multicentre, single-blind, randomised controlled trial. Patients who meet the inclusion criteria will be recruited and randomly assigned to either the JTN treatment group or the basic acupuncture group. Both interventions will be conducted for five consecutive days per week and last for 2  weeks. The primary outcome is the effective rate based on the 14-item Fatigue Scale (FS-14) score. Other outcome measures include the Fatigue Assessment Scale (FAI), the Depression Status Inventory (DSI), and the Self-rating Anxiety Scale (SAS). Plasma adrenocorticotropic hormone (ACTH), plasma c ortisol, and serum...
Source: Trials - March 4, 2019 Category: Research Source Type: clinical trials

Effects of vitamin D supplementation on liver fibrogenic factors in non-alcoholic fatty liver patients with steatohepatitis: study protocol for a randomized clinical trial
This study was designed to examine the effects on vitamin D supplementation on serum levels of vitamin D receptor (VDR), fibrogenic factors, and fibrogenic microRNAs (MiR) in NAFLD patients.MethodsForty-six NAFLD patients will be recruited in this study. After block matching for sex and BMI, they will be randomly assigned to receive 4000  IU/day vitamin D or placebo for 12 weeks. Weight, height, and waist circumference will be measured. Determination of serum fibrogenic MiRs, laminin, collagen type IV, hyaluronic acid, vitamin D, VDR, calcium, blood glucose, serum insulin, lipid profile, liver markers (ALT, A...
Source: Trials - March 4, 2019 Category: Research Source Type: clinical trials

Conditional cash transfers to retain rural Kenyan women in the continuum of care during pregnancy, birth and the postnatal period: protocol for a cluster randomized controlled trial
This study aims to assess the impact, cost-effectiveness and scalability of conditional cash transfers to promote increased contact between pregnant women or women who have recently given birth and the formal healthcare system in Kenya.MethodsThe intervention tested is a conditional cash transfer to women for ANC health visits, a facility birth and PNC visits until their newborn baby reaches 1  year of age. The study is a cluster randomized controlled trial in Siaya County, Kenya. The trial clusters are 48 randomly selected public primary health facilities, 24 of which are in the intervention arm of the study and 24...
Source: Trials - March 1, 2019 Category: Research Source Type: clinical trials

Statistical design and analysis in trials of proportionate interventions: a systematic review
In proportionate or adaptive interventions, the dose or intensity can be adjusted based on individual need at predefined decision stages during the delivery of the intervention. The development of such interve... (Source: Trials)
Source: Trials - February 28, 2019 Category: General Medicine Authors: Jane Candlish, M. Dawn Teare, Judith Cohen and Tracey Bywater Tags: Review Source Type: research

Statistical design and analysis in trials of proportionate interventions: a systematic review
ConclusionsTrials of proportionate staged interventions are being used predominantly within the mental health field. However, few studies consider the different stages of the interventions, either at the design or the analysis phase, and how they may interact with one another. There is a need for further guidance on the design, analyses and reporting across trials of proportionate interventions.Trial registrationProspero, CRD42016033781. Registered on 2 February 2016. (Source: Trials)
Source: Trials - February 28, 2019 Category: Research Source Type: clinical trials

The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam
The overall goal of the Supporting Adolescent Adherence in Vietnam (SAAV) study is to improve understanding of an adherence feedback mHealth intervention designed to help adolescents living with HIV (ALHIV) ma... (Source: Trials)
Source: Trials - February 28, 2019 Category: General Medicine Authors: Mary DeSilva, Cong Nguyen Vu, Rachael Bonawitz, Le Thanh Hai, Nguyen Van Lam, Le Thi Yen, Allen L. Gifford, Jessica Haberer, Dang Thuy Linh and Lora Sabin Tags: Study protocol Source Type: research