Guanxinjing capsule in the treatment of chronic stable angina: study protocol for a randomized controlled trial
This study will investigate whether GXJ can alleviate clinical symptoms, increase the angina-free walking time, and improve quality of life in patients with chronic stable angina (Qi deficiency and blood stasis syndrome). The results of this study will provide clinical evidence for the application of GXJ to the treatment of stable angina.Trial registrationChinese Clinical Trial Registry,ChiCTR1800014258. Registered on 2 January 2018. (Source: Trials)
Source: Trials - October 20, 2018 Category: Research Source Type: clinical trials

Movement through Active Personalised engagement (MAP) — a self-management programme designed to promote physical activity in people with multimorbidity: study protocol for a randomised controlled trial
This study is a single-centre randomised controlled trial, with follow-up at 6 and 12  months. The primary outcome is change in objectively assessed average daily physical activity at 12 months. Secondary outcomes include medication adherence, lifestyle behaviours, quality of life, chronic disease self-efficacy and self-efficacy for exercise. Anthropometric and clinical measurement s include blood pressure, muscle strength, lipid profile, kidney function and glycated haemoglobin (HbA1c). Participants are recruited from primary care. Those between 40 and 85 years of age with multimorbidity, with a good unders...
Source: Trials - October 20, 2018 Category: Research Source Type: clinical trials

Dexamethasone therapy versus surgery for chronic subdural haematoma (DECSA trial): study protocol for a randomised controlled trial
This study is a prospective, multicentre, randomised controlled trial (RCT). Consecutive patients with a CSDH with a Markwalder Grading Scale (MGS) grade 1 to 3 will be randomised to treatment with DXM or BHC. The DXM treatment scheme will be 16  mg DXM per day (8 mg twice daily, days 1 to 4) which is then halved every 3 days until a dosage of 0.5 mg a day on day 19 and stopped on day 20. If the treatment response is insufficient (i.e. persistent or progressive symptomatology due to insufficient haematoma resolution), additional surgery c an be performed. The primary outcomes are the functional outcome by means o...
Source: Trials - October 20, 2018 Category: Research Source Type: clinical trials

Correction to: Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial
Following publication of the original article [1], the authors reported that one of the authors ’ names is spelled incorrectly. In this Correction the incorrect and correct author name are shown. The original p... (Source: Trials)
Source: Trials - October 19, 2018 Category: General Medicine Authors: Mads Gustaf J ørgensen, Navid Mohamadpour Toyserkani, Nana Hyldig, Annette Hougaard Chakera, Lisbet Rosenkrantz Hölmich, Jørn Bo Thomsen and Jens Ahm Sørensen Tags: Correction Source Type: research

A protocol for the process evaluation of a multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission
Attempts to design services to support the delivery of healthcare closer to home have taken various forms as countries respond to an increase in hospital admission rates for older people, who are at risk of ho... (Source: Trials)
Source: Trials - October 19, 2018 Category: General Medicine Authors: Petra M äkelä, Mary Godfrey, Andrea Cradduck-Bamford, Graham Ellis and Sasha Shepperd Tags: Study protocol Source Type: research

The therapeutic potential of attentional bias modification training for insomnia: study protocol for a randomised controlled trial
The efficacy of attentional bias modification (ABM) as a treatment for anxiety and depression has been extensively studied with promising results. Despite some evidence of sleep-related attentional biases in i... (Source: Trials)
Source: Trials - October 19, 2018 Category: General Medicine Authors: Umair Akram, Bronwyn Milkins, Antonia Ypsilanti, John Reidy, Lambros Lazuras, Jodie Stevenson, Lies Notebaert and Nicola L. Barclay Tags: Study protocol Source Type: research

Effectiveness-implementation of COPD case finding and self-management action plans in low- and middle-income countries: global excellence in COPD outcomes (GECo) study protocol
Chronic obstructive pulmonary disease (COPD) is the end result of a susceptible individual being exposed to sufficiently deleterious environmental stimuli. More than 90% of COPD-related deaths occur in low- an... (Source: Trials)
Source: Trials - October 19, 2018 Category: General Medicine Authors: Trishul Siddharthan, Suzanne L Pollard, Shumonta A Quaderi, Andrew J Mirelman, Maria Kathia C árdenas, Bruce Kirenga, Natalie A Rykiel, J Jaime Miranda, Laxman Shrestha, Ram K Chandyo, Adithya Cattamanchi, Susan Michie, Julie Barber, William Checkley and Tags: Study protocol Source Type: research

Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial
Amnestic mild cognitive impairment (aMCI) is considered a risk state for the development of dementia due to Alzheimer ’s disease. It is also a period in which interventions may be most effective in slowing prog... (Source: Trials)
Source: Trials - October 19, 2018 Category: General Medicine Authors: Liselotte De Wit, Deirdre O ’Shea, Melanie Chandler, Tripti Bhaskar, Jared Tanner, Prashanthi Vemuri, Julia Crook, Miranda Morris and Glenn Smith Tags: Study protocol Source Type: research

Video clinics versus standard face-to-face appointments for liver transplant patients in routine hospital outpatient care: study protocol for a pragmatic randomised evaluation of myVideoClinic
This study will evaluate whether a video clinic implemented at the University Hospitals Birmingham (UHB) NHS Foundation Trust improves patient satisfaction compared to standard face-to-face appointments for liver transplant patients.MethodsThis will be a parallel, two-arm, statistician-blinded, randomised evaluation. Clinically stable liver patients at 1 to 5  years post-transplant (n = 180) will be randomised in equal numbers to video clinic appointments (intervention) or standard face-to-face appointments (control). The intervention group will have outpatient appointments from home via a secure video lin...
Source: Trials - October 19, 2018 Category: Research Source Type: clinical trials

Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight)
DiscussionThe study aims to discuss and evaluate BLT as an additive method supporting standardized clinical procedures dealing with severe to moderate depressive symptoms in youth.Trial registrationGerman Clinical Trials Register,DRKS00013188. Registered on November 30, 2017. (Source: Trials)
Source: Trials - October 19, 2018 Category: Research Source Type: clinical trials

Considerations for adaptive design in pediatric clinical trials: study protocol for a systematic review, mixed-methods study, and integrated knowledge translation plan
This study will identify, evaluate, and synthesize the various regulatory, ethical, logistical, and statistical considerations and emerging issues of AD in CTs that could be used to evaluate the use of drugs in children.Methods/designFollowing the development of a peer-reviewed search strategy, a systematic review on AD in CTs will be conducted. Data on regulatory, ethical, logistic, and statistical considerations as well as population and trial design characteristics will be synthesized. A mixed-methods study including surveys and focus groups with regulators, research ethics board members, biostatisticians, clinicians, a...
Source: Trials - October 19, 2018 Category: Research Source Type: clinical trials

Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial
The objective of the current pilot study is to explore the feasibility of a trial investigating the impact of computerized cognitive training, yoga, and an active control intervention (wellness education) in individuals with aMCI by conducting a group-randomized, multisite, parallel, three-arm pilot study. We will establish preliminary effect sizes regarding the association of each intervention with neuroimaging and cognitive and participant-reported measures. We also aim to estimate the strength of association between the various outcomes. The current trial aims to recruit 75 people with aMCI and their 75 cognitively heal...
Source: Trials - October 19, 2018 Category: Research Source Type: clinical trials

Effectiveness-implementation of COPD case finding and self-management action plans in low- and middle-income countries: global excellence in COPD outcomes (GECo) study protocol
This study will be carried out in Nepal, Peru and Uganda, three distinct LMIC settings.Methods/designWe aim to assess the diagnostic accuracy of a simple questionnaire with and without PEF to case-find COPD (GECo1), and examine the effectiveness, cost-effectiveness and implementation of a community-health-worker-supported self-management Action Plan strategy for managing exacerbations of COPD (GECo2). To achieve the first aim, we will enrol a randomly selected sample of up to 10,500 adults aged ≥ 40 years across our three sites, with the goal to enrol 240 participants with moderate-to-severe COPD in to ...
Source: Trials - October 19, 2018 Category: Research Source Type: clinical trials

The therapeutic potential of attentional bias modification training for insomnia: study protocol for a randomised controlled trial
This study specifically aims to determine whether ABM can reduce (i) the presence of an attentional bias for sleep-related threatening words; (ii) insomnia symptom severity; (iii) sleep onset latency; and (iv) pre-sleep cognitive arousal amongst individuals with insomnia compared to a non-treatment control group of individuals with insomnia.Methods/designWe propose a randomised controlled trial of 90 individuals from the general population who meet the criteria for Insomnia Disorder. Following an initial examination for the presence of a sleep-related attentional bias using the dot-probe paradigm, participants will be rand...
Source: Trials - October 19, 2018 Category: Research Source Type: clinical trials

A protocol for the process evaluation of a multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission
DiscussionThis process evaluation will enable evaluation of implementation processes prior to knowing trial outcomes. We encompass domains of reach, delivery, change, context and response to the intervention by patients, their carers, health professionals and the health system.Trial registrationISRCTN60477865. Registered on 10 March 2014. Trial sponsor: University of Oxford.Version 3.1, registered on 14 June 2016. (Source: Trials)
Source: Trials - October 19, 2018 Category: Research Source Type: clinical trials

Correction to: Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial
Following publication of the original article [1], the authors reported that one of the authors ’ names is spelled incorrectly. In this Correction the incorrect and correct author name are shown. The original publication of this article has been corrected. (Source: Trials)
Source: Trials - October 19, 2018 Category: Research Source Type: clinical trials

ConFIRM trial - conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation: a protocol for a multicentric, prospective randomized trial
To date, there is no consensus on the ideal management strategy of patients with poor ovarian response (POR) to controlled ovarian stimulation (COS) for in vitro fertilization (IVF). Currently, these patients ... (Source: Trials)
Source: Trials - October 17, 2018 Category: General Medicine Authors: L éa Delbos, Elsa Parot-Schinkel, Hady El Hachem, Guillaume Legendre, Philippe Descamps, Lisa Boucret, Véronique Ferré-L’Hotellier, Pauline Jeanneteau, Cécile Dreux, Catherine Morinière, Pascale May-Panloup and Pierre-Emmanuel Bouet Tags: Study protocol Source Type: research

Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol
In the Swedish population aged between 50 and 64 years only 7.1% reach the recommended level of physical activity. Physical activity on prescription (PAP) has been used in Sweden since the beginning of the twe... (Source: Trials)
Source: Trials - October 17, 2018 Category: General Medicine Authors: Peter Nymberg, Eva Ekvall Hansson, Emelie Stenman, Susanna Calling, Kristina Sundquist, Jan Sundquist and Bengt Z öller Tags: Study protocol Source Type: research

Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial
Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., A... (Source: Trials)
Source: Trials - October 17, 2018 Category: General Medicine Authors: Romy Scholz, Johannes Lemcke, Ullrich Meier and Dirk Stengel Tags: Study protocol Source Type: research

Expert versus generalist inserters for peripheral intravenous catheter insertion: a pilot randomised controlled trial
Peripheral intravenous catheters (PVCs) are essential invasive devices, with 2 billion PVCs sold each year. The comparative efficacy of expert versus generalist inserter models for successful PVC insertion and... (Source: Trials)
Source: Trials - October 17, 2018 Category: General Medicine Authors: Nicole Marsh, Joan Webster, Emily Larsen, Jodie Genzel, Marie Cooke, Gabor Mihala, Sue Cadigan and Claire M Rickard Tags: Research Source Type: research

Expert versus generalist inserters for peripheral intravenous catheter insertion: a pilot randomised controlled trial
ConclusionThis pilot trial confirmed the feasibility and need for a large, multicentre RCT to test these PVC insertion models.Trial registrationAustralian New Zealand Clinical Trials Registry,ACTRN12616001675415. Registered on 6 December 2016. (Source: Trials)
Source: Trials - October 17, 2018 Category: Research Source Type: clinical trials

Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial
DiscussionSYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care.Trial registrationInternational Standard Randomised Controlled Trial Number:ISRCTN13838310. Registered on 10 November 2016. (Source: Trials)
Source: Trials - October 17, 2018 Category: Research Source Type: clinical trials

Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol
This study is the first to explore the effect of mindfulness on adherence to PAP and test the feasibility of the study design.Trial registrationClinicalTrials.gov,NCT02869854. Registered on 26 August 2016. (Source: Trials)
Source: Trials - October 17, 2018 Category: Research Source Type: clinical trials

ConFIRM trial - conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation: a protocol for a multicentric, prospective randomized trial
DiscussionThis is the first randomized controlled trial to compare the outcomes of IVF and embryo transfer to conversion to IUI in patients with POR to COS. If our study shows that conversion to IUI is non-inferior to IVF in terms of clinical efficiency and live birth rate, it would confirm IUI as a better alternative for patients, both individually (less invasive and more patient-friendly) and collectively (lower cost).Trials registrationClinicalTrials.gov, ID:NCT03362489. Registered on January 10th, 2018. (Source: Trials)
Source: Trials - October 17, 2018 Category: Research Source Type: clinical trials

Correction to: Evaluating the impact of Marie Stopes International ’s digital family planning counselling application on the uptake of long-acting and permanent methods of contraception in Vietnam and Ethiopia: a study protocol for a multi-country cluster randomised controlled trial
Following publication of the original article [1], the authors requested a correction be made, indicating L. Bates as the first author only. There is no joint first authorship. (Source: Trials)
Source: Trials - October 16, 2018 Category: General Medicine Authors: Laura A. Bates, Joseph P. Hicks, John Walley and Emily Robinson Tags: Correction Source Type: research

Effect of electroacupuncture at homotopic and heterotopic acupoints on abdominal pain in patients with irritable bowel syndrome: study protocol for a randomized controlled trial
Acupuncture has been widely applied in the clinic to treat irritable bowel syndrome (IBS), but the underlying mechanism remains unknown. Diffuse noxious inhibitory control (DNIC) is deficient in patients with ... (Source: Trials)
Source: Trials - October 16, 2018 Category: General Medicine Authors: Yanhui Peng, Hui You, Xiaoman Chen, Yanbing Chen, Yiling Yang, Jianpeng Huang, Nenggui Xu and Jianhua Liu Tags: Study protocol Source Type: research

Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
Large multicentre trials are complex and expensive projects. A key factor for their successful planning and delivery is how well sites meet their targets in recruiting and retaining participants, and in collec... (Source: Trials)
Source: Trials - October 16, 2018 Category: General Medicine Authors: Kate F. Walker, Julie Turzanski, Diane Whitham, Alan Montgomery and Lelia Duley Tags: Research Source Type: research

The clinical and cost effectiveness of adapted dialectical behaviour therapy (DBT) for bipolar mood instability in primary care (ThrIVe-B programme): a feasibility study
In bipolar spectrum disorder, some individuals experience ongoing, frequent fluctuations in mood outside of affective episodes. There are currently no evidence-based psychological interventions designed to add... (Source: Trials)
Source: Trials - October 16, 2018 Category: General Medicine Authors: Kim Wright, Alyson Dodd, Fiona C Warren, Antonieta Medina-Lara, Rod Taylor, Steven Jones, Christabel Owens, Mahmood Javaid, Barney Dunn, Julie E Harvey, Alexandra Newbold and Tom Lynch Tags: Study protocol Source Type: research

Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study
Site performance is key to the success of large multicentre randomised trials. A standardised set of clear and accessible summaries of site performance could facilitate the timely identification and resolution... (Source: Trials)
Source: Trials - October 16, 2018 Category: General Medicine Authors: Diane Whitham, Julie Turzanski, Lucy Bradshaw, Mike Clarke, Lucy Culliford, Lelia Duley, Lisa Shaw, Zoe Skea, Shaun P. Treweek, Kate Walker, Paula R. Williamson and Alan A. Montgomery Tags: Research Source Type: research

Cluster-randomized trial of monthly malaria prophylaxis versus focused screening and treatment: a study protocol to define malaria elimination strategies in Cambodia
DiscussionDespite the apparent urgency, the key operational elements of proposed malaria elimination strategies in Southeast Asian mobile and migrant populations, including the Military, have yet to be rigorously tested in a well-controlled clinical study. Here, we present a protocol for the primary evaluation of two treatment paradigms – monthly malaria prophylaxis and focused screening and treatment – to achieve malaria elimination in a Cambodian military population. We will also assess the feasibility and incremental benefit of outdoor-biting vector intervention – permethrin-treated clothing. In the pr...
Source: Trials - October 16, 2018 Category: Research Source Type: clinical trials

Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial
DiscussionIdentifying medium-term interventions able to improve chronic migraine is relevant to manage this illness. The present randomized trial might represent a step forward for managing chronic migraine by means of psychological interventions.Trial registrationClinicalTrial.gov Identifier:NCT03404336. Registered on 19 January 2018. (Source: Trials)
Source: Trials - October 16, 2018 Category: Research Source Type: clinical trials

Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study
ConclusionsWe have established a core set of metrics for measuring the performance of sites in multicentre randomised trials. These metrics could improve trial conduct by enabling researchers to identify and address problems before trials are adversely affected. Future work could evaluate the effectiveness of using the metrics and reporting tool. (Source: Trials)
Source: Trials - October 16, 2018 Category: Research Source Type: clinical trials

The clinical and cost effectiveness of adapted dialectical behaviour therapy (DBT) for bipolar mood instability in primary care (ThrIVe-B programme): a feasibility study
DiscussionProceeding to a definitive trial will be indicated if the following criteria are met: (1) trial participation does not lead to serious negative consequences for our participants; (2) any serious concerns about the acceptability and feasibility of the trial procedures can be rectified prior to a definitive trial; (3) follow-up data at 9 months are available for at least 60% of participants; (4) at least 60% of patients in the ThrIVe-B arm complete treatment.Trial registrationISRCTN,ISRCTN54234300. Registered on 20 July 2017. (Source: Trials)
Source: Trials - October 16, 2018 Category: Research Source Type: clinical trials

Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
ConclusionsThis review identifies a list of metrics to monitor site performance within multicentre randomised trials. Those that would be easy to collect, and for which monitoring might trigger actions to mitigate problems at site level, merit further evaluation. (Source: Trials)
Source: Trials - October 16, 2018 Category: Research Source Type: clinical trials

Effect of electroacupuncture at homotopic and heterotopic acupoints on abdominal pain in patients with irritable bowel syndrome: study protocol for a randomized controlled trial
This study is a randomized, single-blinded, controlled, four-arm parallel trial. A total of 144  patients will be randomly assigned to four groups: a homotopic noxious stimulation group (group A), a homotopic innocuous stimulation group (group B), a heterotopic noxious stimulation group (group C), and a heterotopic innocuous stimulation group (group D). Each patient will receive 14 sessions o f treatment, twice per week for 7 weeks. The primary outcome will be pain intensity measured with the visual analog scale. The secondary outcomes will include the IBS Symptom Severity Scale, IBS Quality of Life question...
Source: Trials - October 16, 2018 Category: Research Source Type: clinical trials

Correction to: Evaluating the impact of Marie Stopes International ’s digital family planning counselling application on the uptake of long-acting and permanent methods of contraception in Vietnam and Ethiopia: a study protocol for a multi-country cluster randomised controlled trial
Following publication of the original article [1], the authors requested a correction be made, indicating L. Bates as the first author only. There is no joint first authorship. (Source: Trials)
Source: Trials - October 16, 2018 Category: Research Source Type: clinical trials

Prevention of striae gravidarum: study protocol for a pilot randomised controlled trial
Striae gravidarum (stretch marks) are considered the most common connective tissue/skin change in pregnancy. Though not a health issue they can affect women in different ways, for example, cause stress or be a... (Source: Trials)
Source: Trials - October 12, 2018 Category: General Medicine Authors: Miriam Brennan, Mike Clarke, John Newell and Declan Devane Tags: Study protocol Source Type: research

Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial
Recent data suggest that 10 –20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decl... (Source: Trials)
Source: Trials - October 12, 2018 Category: General Medicine Authors: C édric Gil-Jardiné, Samantha Al Joboory, Juliane Tortes Saint Jammes, Guillaume Durand, Régis Ribéreau-Gayon, Michel Galinski, Louis-Rachid Salmi, Philippe Revel, Cyril Alexandre Régis, Guillaume Valdenaire, Emmanuel Poulet, Karim Tazarourte and Emm Tags: Study protocol Source Type: research

Conservative therapy for the treatment of patients with somatic tinnitus attributed to temporomandibular dysfunction: study protocol of a randomised controlled trial
Tinnitus is a highly prevalent symptom affecting 10 –15% of the adult population. It often affects patient quality of life and frequently causes distress. When subjective tinnitus can be elicited by the somatos... (Source: Trials)
Source: Trials - October 12, 2018 Category: General Medicine Authors: Sarah Michiels, Annemarie Christien van der Wal, Evelien Nieste, Paul Van de Heyning, Marc Braem, Corine Visscher, Vedat Topsakal, Annick Gilles, Laure Jacquemin, Marianne Hesters and Willem De Hertogh Tags: Study protocol Source Type: research

Conservative therapy for the treatment of patients with somatic tinnitus attributed to temporomandibular dysfunction: study protocol of a randomised controlled trial
This study is a randomised controlled trial with a delayed treatment design. Patients with a TMD (TMD pain screener ≥ 3 points) or oral parafunctions (such as clenching and bruxism), who are suffering from moderate to severe subjective tinnitus (Tinnitus Functional Index (TFI) between 25 and 90 points), will be recruited from the tertiary tinnitus clinic of the University Hospital of Antwerp, Edegem, Belgium.Patients will be excluded in case of clear otological or neurological causes of the tinnitus, progressive middle ear pathology, intracranial pathology, traumatic cervical spine or temporomandibular injury in ...
Source: Trials - October 12, 2018 Category: Research Source Type: clinical trials

Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial
DiscussionIn 2012, the year of the last national survey in France, 10.6 million people attended the ER, some of whom did so several times since 18 million visits were recorded in the same year. The SOFTER 3 study therefore addresses a major public health challenge.Trial registrationClinical Trials.NCT03400813. Registered 17 January 2018 – retrospectively registered. (Source: Trials)
Source: Trials - October 12, 2018 Category: Research Source Type: clinical trials

Prevention of striae gravidarum: study protocol for a pilot randomised controlled trial
DiscussionThis pilot trial will evaluate the feasibility of conducting the main study to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. It will potentially initiate the generation of high-quality evidence to guide women in their choice of anti-stretch mark product.Trial registrationISRCTN Registry,ISRCTN76992326. Registered on 14 July 2017. (Source: Trials)
Source: Trials - October 12, 2018 Category: Research Source Type: clinical trials

Effect of training community health workers and their interventions on cardiovascular disease risk factors among adults in Morogoro, Tanzania: study protocol for a cluster randomized controlled trial
This study aims at assessing the effect of training CHWs and their CVD-specific interventions for reduction of hypertension and other CVD risk factors among adults in Morogoro, Tanzania.MethodsThis study will use a mixed-methods design with both quantitative and qualitative approaches. A baseline quantitative survey will be conducted to assess knowledge, prevalence, and determinants of CVD risk factors in a random sample of 2950 adults aged 25 –64 years. A cluster randomized controlled design with pre-test will be used to assess the effects of CVD-specific interventions delivered by CHWs on reduction of blood pr...
Source: Trials - October 11, 2018 Category: Research Source Type: clinical trials

“Yellow-dragon Wonderful-seed Formula” for hyperuricemia in gout patients with dampness-heat pouring downward pattern: a pilot randomized controlled trial
ConclusionsYWM, which modified on the basis ofTwo Wonderful Herbs Powder (2WHP), does not show significant hypouricemic effect. There is a possibility that Gypsum Fibrosum may provide additional effects to YWF in decreasing the urine urate levels but cannot add benefits to YWF in other outcome measures.Trial registrationChinese Clinical Trial Registry,ChiCTR-TRC-12001933. Registered on 10 February 2012. (Source: Trials)
Source: Trials - October 11, 2018 Category: Research Source Type: clinical trials

A community-based intervention (Young SMILES) to improve the health-related quality of life of children and young people of parents with serious mental illness: randomised feasibility protocol
DiscussionThis paper details the rationale, design, training and recruitment methods for a feasibility study to inform the design and effective implementation of a larger scale randomised controlled trial of Young SMILES.Trial RegistrationISRCTN36865046, registered 18 December 2015. (Source: Trials)
Source: Trials - October 11, 2018 Category: Research Source Type: clinical trials

Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial
Endoscopic ultrasonography (EUS)-guided drainage has become the first-line therapy for late peri-pancreatic fluid collection (PFC). Double pigtail plastic stents (DPPS) and lumen-apposing metal stents (LAMS) a... (Source: Trials)
Source: Trials - October 11, 2018 Category: General Medicine Authors: Hui-Yun Zhu, Pei Xie, Ying-Xiao Song, Zhao-Shen Li, Zhen-Dong Jin and Yi-Qi Du Tags: Study protocol Source Type: research

Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation
The World Health Organization recommends rapid ( ≤ 7 days) or same-day initiation of antiretroviral treatment (ART) for HIV-positive patients. South Africa adopted this recommendation in 2017, but multiple clin... (Source: Trials)
Source: Trials - October 11, 2018 Category: General Medicine Authors: S Rosen, M Maskew, A T Brennan, M P Fox, L Vezi, P D Ehrenkranz and W D F Venter Tags: Study protocol Source Type: research

Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation
DiscussionSLATE II improves upon the SLATE I study by reducing the number of reasons for delaying ART initiation and allowing more patients with TB symptoms to start ART on the day  of diagnosis. If successful, SLATE II will provide a simple and streamlined approach that can readily be adopted in other settings without investment in additional technology.Trial registrationClinicalTrials.gov,NCT03315013. Registered on 19 October 2017. (Source: Trials)
Source: Trials - October 11, 2018 Category: Research Source Type: clinical trials

Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial
AbstractBackgroundEndoscopic ultrasonography (EUS)-guided drainage has become the first-line therapy for late peri-pancreatic fluid collection (PFC). Double pigtail plastic stents (DPPS) and lumen-apposing metal stents (LAMS) are commonly used for PFC drainage. Recently, a multi-institutional consensus on PFC drainage has recommended that LAMS should be the standard care for patients with walled-off necrosis (WON). However, given the poor quality of evidence, we aim to perform a large-scale randomized controlled trial to determine whether LAMS is superior to DPPS for WON drainage.Methods/designThe study is an open-label, p...
Source: Trials - October 11, 2018 Category: Research Source Type: clinical trials

Psychological Support for Personality (PSP) versus treatment as usual: study protocol for a feasibility randomized controlled trial of a low intensity intervention for people with personality disorder
Previous research has demonstrated the clinical effectiveness of long-term psychological treatment for people with some types of personality disorder. However, the high intensity and cost of these intervention... (Source: Trials)
Source: Trials - October 10, 2018 Category: General Medicine Authors: Mike J Crawford, Lavanya Thana, Jennie Parker, Oliver Turner, Kwek Pei Xing, Mary McMurran, Paul Moran, Timothy Weaver, Barbara Barrett, Amy Claringbold, Paul Bassett and Rahil Sanatinia Tags: Study protocol Source Type: research