National Health Service (NHS) Clinical Trials This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) protocol
DiscussionThe PUrE trial aims to provide robust evidence on health status, quality of life, clinical outcomes and resource use to directly inform choice and National Health Service provision of the three treatment options.Trial registrationISRCTN:ISRCTN98970319. Registered on 11 November 2015. (Source: Trials)
Source: Trials - June 3, 2020 Category: Research Source Type: clinical trials

A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson ’s disease: a study protocol for a randomised controlled trial
DiscussionThe trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD ® provide greater benefit and determine the cost-effectiveness of both interventions.Trial registrationInternational Standard Randomised Controlled Trials Number (ISRCTN) Registry,ID: 12421382. Registered on 18 April 2016. (Source: Trials)
Source: Trials - May 26, 2020 Category: Research Source Type: clinical trials

REDUCE (Reviewing long-term antidepressant use by careful monitoring in everyday practice) internet and telephone support to people coming off long-term antidepressants: protocol for a randomised controlled trial
DiscussionHelping patients reduce and stop antidepressants is often challenging for practitioners and time-consuming for very busy primary care practices. If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups.Trial registrationISRCTN:12417565. Registered on 7 October 2019. (Source: Trials)
Source: Trials - May 23, 2020 Category: Research Source Type: clinical trials

Low-Intensity Guided Help Through Mindfulness (LIGHTMIND): study protocol for a randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help to supported cognitive behavioural therapy self-help for adults experiencing depression
This study seeks to investigate the effectiveness of an alternative to CBT-SH. Mindfulness-based cognitive therapy (MBCT) differs fr om CBT in focus, approach and practice, and may be more effective with a higher number of treatment completions.Methods/designThis is a definitive randomised controlled trial comparing supported MBCT self-help (MBCT-SH) with CBT-SH for adults experiencing mild to moderate depression being treated in IAPT services. We will recruit 410 participants experiencing mild to moderate depression from IAPT services and randomise these to receive either an MBCT-based self-help workbook or a CBT-based se...
Source: Trials - May 3, 2020 Category: Research Source Type: clinical trials

Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)
This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination.Trial registrationThe stu...
Source: Trials - January 14, 2020 Category: Research Source Type: clinical trials

Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine
DiscussionThe clinical effectiveness and cost effectiveness of liposomal bupivacaine have yet to be evaluated in the National Health Service, making this trial appropriate and timely.Trial registrationISRCTN registry,ISRCTN54191675. Registered on 14 November 2017. (Source: Trials)
Source: Trials - December 15, 2019 Category: Research Source Type: clinical trials

TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial
DiscussionIt is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care, therefore, holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic, cluster RCT should provide robust evidence in a primary-care setting to inform future guidelines.Trial registrationISCRTN registry,...
Source: Trials - September 1, 2019 Category: Research Source Type: clinical trials

Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped-wedge cluster-randomised controlled trial
DiscussionARK-Hospital aims to provide a feasible, sustainable and generalisable mechanism for increasing antibiotic stopping in patients who no longer need to receive them at ‘review and revise’.Trial registrationISRCTN Current Controlled Trials,ISRCTN12674243. Registered on 10 April 2017. (Source: Trials)
Source: Trials - July 10, 2019 Category: Research Source Type: clinical trials

Coping with Uncertainty in Everyday Situations (CUES ©) to address intolerance of uncertainty in autistic children: study protocol for an intervention feasibility trial
DiscussionThe present study will provide evidence on the acceptability of the CUES intervention to parents and children, and the feasibility of recruitment and delivery to inform the design and sample size for a full-scale randomised controlled trial. Qualitative data will be obtained to understand how feasible CUES is for families, and the experiences of participants regarding their experiences of the intervention.Trial registrationISRCTN,ISRCTN10139240. Registered on 14 May 2018. (Source: Trials)
Source: Trials - June 26, 2019 Category: Research Source Type: clinical trials

Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma: protocol for a randomised patient-focused pilot trial of delivering the ASICA intervention as a means to earlier detection of recurrent and second primary melanoma
This study will determine if a full-scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed to determine the effectiveness of the intervention. ASICA is a pilot study evaluating the effectiveness of the practice of digitally supported TSSE in those affected by melanoma.Trial registrationClinical Trials.gov,NCT03328247. Registered on 1 November 2017. (Source: Trials)
Source: Trials - June 2, 2019 Category: Research Source Type: clinical trials

Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis
DiscussionIf effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking.Trial registrationClinicalTrials.gov, ID:NCT03231553. Registered on 20 July 2017. (Source: Trials)
Source: Trials - May 21, 2019 Category: Research Source Type: clinical trials

Clarithromycin and endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps: study protocol for the MACRO randomised controlled trial
The objective of this trial is to establish the comparative effectiveness of endoscopic sinus surgery (ESS) or a prolonged course of antibiotics (clarithromycin) in adult patients with CRS in terms of symptomatic improvement and costs to the National Health Service compared with standard medical care (intranasal medication) at 6 months.Methods/designA three-arm parallel-group trial will be conducted with patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care). They will be randomised to receive: (1) intranasal medication plus ESS, (2) intranasal medication plus clar...
Source: Trials - April 28, 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 3, 2019 Category: Research Source Type: clinical trials

Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return
Conditions: Concussion, Brain; Motor Vehicle Accident Interventions: Diagnostic Test: Clinical assessment (SCAT5); Diagnostic Test: ImPACT; Behavioral: CANTAB; Diagnostic Test: I-PAS; Biological: Saliva sample; Other: fMRI Sponsors: University of Cambridge; Global Institute for Motorsport Safety (GIMSS); Neuro Kinetics Incorporated; Cambridge University Hospitals NHS (National Health Service) Foundation Trust; Federation Internacionale de l'Automobile Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 18, 2019 Category: Research Source Type: clinical trials