EvaLuation of early CRRT and beta-blocker InTervention in patients with ECMO (ELITE) trial: study protocol for a 2 × 2 partial factorial randomized controlled trial
DiscussionThis trial will help define the role of early CRRT and beta-blockade in ECMO patients. There have been 89 patients enrolled at 10 hospitals in study A and is ongoing. However, study B was stopped in August 2019 in the absence of any patients being enrolled.Trial registrationClinicalTrials.govNCT03549923. Registered on 8 June 2018. World Health Organization International Clinical Trials Registry Platform (WHO ICTEP) network. The Ethics Committee of Beijing Anzhen Hospital Approval ID is 2018013. (Source: Trials)
Source: Trials - August 19, 2022 Category: Research Source Type: clinical trials

Access to unpublished protocols and statistical analysis plans of randomised trials
ConclusionsMost study investigators did not share their unpublished protocols or SAPs upon direct request. Alternative strategies are needed to increase transparency of randomised trials and ensure access to protocols and SAPs. (Source: Trials)
Source: Trials - August 17, 2022 Category: Research Source Type: clinical trials

Prevention and early treatment of the long-term physical effects of COVID-19 in adults: design of a randomised controlled trial of resistance exercise —CISCO-21
DiscussionEthical approval has been granted by the National Health Service (NHS) West of Scotland Research Ethics Committee (REC) (reference: GN20CA537) and recruitment is ongoing. Trial findings will be disseminated through patient and public forums, scientific conferences and journals.Trial registrationClinicialTrials.govNCT04900961. Prospectively registered on 25 May 2021 (Source: Trials)
Source: Trials - August 15, 2022 Category: Research Source Type: clinical trials

Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial
AbstractBackground and purposePoststroke urinary incontinence (PSI) is prevalent in stroke survivors, and high-quality evidence is required to guide clinical practice. Previous studies have demonstrated the curative effect of repetitive transcranial magnetic stimulation (rTMS) for urinary incontinence in individuals with multiple sclerosis (MS), Parkinson ’s disease (PD), and spinal cord injury (SCI). Here, we describe the protocol for a randomized controlled trial to evaluate the efficacy and safety of low-frequency rTMS on the contralesional primary motor cortex (M1) for the treatment of PSI.Methods and analysisIn this...
Source: Trials - August 13, 2022 Category: Research Source Type: clinical trials

The effects of Rosa foetida extract along with self-care education on primary dysmenorrhea: study protocol for a randomized clinical trial
This study will investigate the effect ofRosa foetida extract, along with self-care behavior education on primary dysmenorrhea among female students of Babol University of medical sciences.Methods/designA randomized clinical trial will be performed on single students, aged 18 to 24 years. The research samples will be divided into three groups. The students will receive self-care behavior education on dysmenorrhea. Following the education, two of the groups will receiveRosa foetida extract capsules and placebo capsules in two consecutive cycles every 8 h for two successive days, respectively. The capsules will have similar ...
Source: Trials - August 9, 2022 Category: Research Source Type: clinical trials

Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study
This study will guide treatment decision-making and clinical practice guidelines regarding the effectiveness of various prophylactic catheter washout policies in men and women living with LTC. This research has received ethical approval from Wales Research Ethics Committee 6 (19/WA/0015).Trial registrationISRCTNISRCTN17116445. Registered prospectively on 06 November 2019 (Source: Trials)
Source: Trials - August 4, 2022 Category: Research Source Type: clinical trials

GeneXpert or chest-X-ray or tuberculin skin testing for household contact assessment (GXT): protocol for a cluster-randomized trial
DiscussionThis randomized trial is meant to provide high-quality evidence to inform WHO recommendations on investigation of household contacts, as currently these are based on very low-quality evidence.Trial registrationClinicalTrials.gov NCT04528823. (Source: Trials)
Source: Trials - August 2, 2022 Category: Research Source Type: clinical trials

Effect of vibration associated with cryotherapy on vaccine-related pain and anxiety levels in adults: study protocol for a randomized clinical trial
This study aims to evaluate the effect of high-frequency vibration associated with cryotherapy on the levels of self-reported pain and anxiety related to administration of the Influenza vaccine intramuscularly in adults.MethodsA two-arm, parallel, randomized clinical trial conducted in a Brazilian Primary Health Care Unit is proposed. A sample of 350 adults will be randomly assigned to participate in the control group, receiving the vaccine intramuscularly according to the standard protocol of the service, or in the intervention group, receiving the vaccine by the same route and using a portable device of high frequency vi...
Source: Trials - August 1, 2022 Category: Research Source Type: clinical trials

Effectiveness of a training intervention to improve the management of vertigo in primary care: a multicentre cluster-randomised trial, VERTAP
DiscussionWith the improvement of the diagnosis and management of vertigo by family doctors after this training, we expect an increase in the proportion of specific diagnoses, a decrease in the prescription of antivertigo agents, a decrease in referrals to ENT or neurology specialists and a reduction in the duration of sick leave due to temporary disability. The blended training will be easily expanded within primary care services, since it is mainly delivered online, with a single face-to-face session to ensure that the manoeuvres have been adequately learned.Trial registrationClinicalTrials.govNCT04929444. Registered Jun...
Source: Trials - July 29, 2022 Category: Research Source Type: clinical trials

A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study
ConclusionsThe adherence to SPIRIT guidelines has improved in the UK from 2012 to 2016 but remains on a modest level, especially for non-industry-sponsored RCTs. (Source: Trials)
Source: Trials - July 27, 2022 Category: Research Source Type: clinical trials

NeuroSAFE PROOF: study protocol for a single-blinded, IDEAL stage 3, multi-centre, randomised controlled trial of NeuroSAFE robotic-assisted radical prostatectomy versus standard robotic-assisted radical prostatectomy in men with localized prostate cancer
DiscussionNeuroSAFE PROOF is the first RCT of intra-operative frozen section during radical prostatectomy in the world. It is properly powered to evaluate a difference in the recovery of EF for men undergoing RARP assessed by patient-reported outcome measures. It will provide evidence to guide the use of the NeuroSAFE technique around the world.Trial registrationNCT03317990 (23 October 2017). Regional Ethics Committee; reference 17/LO/1978. (Source: Trials)
Source: Trials - July 22, 2022 Category: Research Source Type: clinical trials

Incannex Receives Ethics Approval to Commence Phase 1 Clinical Trial of Multi-Use Anti-Inflammatory Drug IHL-675A
MELBOURNE, Australia, July 21, 2022. Incannex Healthcare Limited ( ' Incannex ' or the ' Company ' ) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 21, 2022 Category: Pharmaceuticals Source Type: clinical trials

Evaluating a Clinical Ethics Committee (CEC) Implementation Process
Condition:   Service Evaluation Interventions:   Other: Survey1;   Other: semi-structured interview_1;   Other: semi-structured interview_2;   Other: semi-structured interview_3;   Other: survey_2 Sponsor:   Azienda Unità Sanitaria Locale Reggio Emilia Enrolling by invitation (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 20, 2022 Category: Research Source Type: clinical trials