Introduction to Centre Randomized

METHODS AND RESULTS We conducted a secondary analysis of a multi-centre randomized trial population of 48 282 consecutive patients attending hospital with suspected acute coronary syndrome.

In this issue of Peritoneal Dialysis International, a multicentre randomized controlled trial from Malaysia found locally made peritoneal dialysis (PD) sets containing polyvinyl chloride (PVC) had similar peritonitis rates, Kt/V, and creatinine clearance to overseas-made sets that were non-PVC.

METHODS Sera from two prospective multicentre randomized controlled trials were analyzed for miRNA levels using the Nanostring nCounter platform and quantitative RT-PCR.

This single-centre randomized, double blind, controlled trial, enrolled 70 patients (35 control and 35 RIPostC).

INTRODUCTION The Indonesian INOVASIA study is an ongoing multicentre randomized, open controlled trial of pravastatin for the prevention of preeclampsia in patients deemed to be high risk.

Using data from a multicentre randomized controlled trial of 2,447 open fracture patients, the primary objective of this secondary analysis is to determine if a relationship exists between timing of wound I&D (within six hours of injury vs beyond six hours) and subsequent reoperation rate for infection or healing complications within one year for patients with open limb fractures requiring surgical treatment.

This trial was a predefined sub-study of a multicentre randomized clinical trial.

Design, Setting, and Participants This randomized clinical trial is a post hoc follow-up study that analyzes the results of the open-label Multicentre Randomized Controlled Phase III Trial, which enrolled patients from 13 different centers in France and was conducted from October 26, 2009, to April 4, 2012.

Methods A total of 106 patients with DSM-5 diagnosis of psychotic disorder and at least moderate level of paranoid ideations will be recruited for this multicentre randomized controlled trial (RCT).

Patients at least 6 months post-CRT implant were recruited in a prospective single-centre randomized single-blind crossover study.

In this single-centre randomized controlled trial, patients are eligible for inclusion when they are ≥18 years of age and cardiac surgery is scheduled at least 8 weeks from informed consent.

In a multicentre Randomized Controlled Trial (RCT), 236 working-age cancer survivors with an employment contract will be randomly allocated to a usual care group or an intervention group receiving a multidisciplinary rehabilitation program, combining occupational therapy facilitating work retention (e.

Method: Patients with RA in 28-joint Disease Activity Score (DAS28) remission (≥ 6 months) and treated with etanercept 50 mg weekly (≥ 1 year) were included in the pragmatic 1 year open-label multicentre randomized controlled TapERA (Tapering Etanercept in Rheumatoid Arthritis) trial.

210 patients of ASA physical status I to III, aged 21 to 80 years old, undergoing general anesthesia requiring tracheal intubation were prospectively recruited into this two-centre randomized controlled trial, from June 2016 to April 2019.

Methods This was a single-centre randomized controlled trial.

METHODS The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study.

Methods and Analysis: This multicentre randomized controlled trial will enroll 132 patients with PHN from 3 hospitals.

We aimed to investigate the combination of home stretching exercises and spinal manipulative therapy in a multicentre randomized controlled clinical trial, carried out in multidiscipline ary primary care clinics.

For further verification, a large sample multicentre randomized controlled study should be performed to explore a treatment scheme for Chinese children with even greater efficacy.

Methods This study is a single-centre randomized controlled superiority trial with 50 colon cancer participants.

Methodology: A prospective, non-blinded multi-centre randomized controlled trial (RCT) was performed to evaluate the incidence of SSI postlaparotomy using incisional NPWT compared to a standard dressing.

Methods: This was a prospective single-centre randomized controlled clinical trial.

We analyzed the factors associated with mortality in a cohort of moderately ill COVID-19 patients enrolled in a multicentre randomized trial on convalescent plasma.

MATERIALS AND METHODS In a multicentre randomized clinical trial, 32 individuals received surgical debridement (CG), and 34 adjunct use of DBBM and NBCM (TG).

Methods: In this feasibility multicentre randomized controlled trial we compared MRI alone versus Mx+US in women at intermediate BC-risk (allocation ratio 1:1).

Myo-inositol is effective in normalizing ovarian function, improving oocyte and embryo quality in PCOS, however further evaluations by large multicentre randomized controlled trials are needed to assess the clinical pregnancy and live birth rates in ART.

Large, high quality, multi-centre randomized trials will help determine which interventions are effective in reducing the incidence of postoperative AKI among patients undergoing elective AAA repair.

In specific, the role of colchicine has been definitely established based on the results of multicentre randomized clinical trials.

Methods This was a secondary analysis of data collected from a multicentre randomized controlled trial assessing the quality of CPR in teams with and without a CPR Coach.

Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospitalacquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial.

This was a post hoc analysis of a multicentre randomized trial comparing fibrinogen concentrate with cryoprecipitate (FIBRES trial) in bleeding cardiac surgical patients.

The multicentre randomized GOLD FORCE trial was conducted to evaluate non-inferiority of safety and efficacy of PVAC Gold PVI compared to ST-CF ablation for paroxysmal AF.

A multicentre randomized control trial is required comparing robotic, open and laparoscopic techniques.

Method This was a subgroup analysis of a multicentre randomized trial that included patients scheduled for elective colectomy.

This multicentre randomized double-blind crossover study evaluates the impact of these amino acids on the gut barrier and microbiota.

Methods: This was a single-centre randomized controlled trial.

Future multi-centre randomized control trials should address the question of technique superiority while minimizing associated complications and capturing patient perspectives.

Further investigation with more well-organized multicentre randomized trial is warranted.

METHODS This was a multi-centre randomized controlled study across four HIV centres.

RESEARCH QUESTION Is an online lifestyle coaching platform more effective at modifying periconceptional behaviours than standard advice offered by the UK National Health Service (NHS)? DESIGN Women with subfertility or recurrent miscarriage were recruited to a two-centre randomized controlled trial.

Six patients were identified in a cohort of patients with relapsed ALL among 564 analyzed patients with relapsed ALL registered in the multicentre randomized trial ALL-REZ BFM 2002.

We analysed serum of 111 patients from a multicentre randomized controlled trial ‘RETRO’.

This prospective single-centre randomized clinical study was conducted at a University Hospital Surgical Intensive Care Unit and included consecutive, postoperative ICU patients fulfilling the inclusion criteria.

Results We included 638 multicentre randomized controlled trials ( n patients = 615,907) that met the eligibility criteria.

METHODS Secondary analysis of a UK multicentre randomized controlled trial (Wound Healing in Surgery for Trauma; WHiST) dataset including adults aged 16 years or over following surgery for lower limb major trauma.

The superiority of coronary artery bypass grafting with a single internal thoracic artery and saphenous vein grafts over percutaneous coronary intervention has been demonstrated in large, multicentre randomized controlled trials, particularly for patients with diabetes and complex coronary disease.

Aims This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder.

Methods In this multi-centre randomized open-labelled prospective study, 200 patients with decompensated cirrhosis were randomly assigned at a ratio of 1:1.

Methods HOLLANT is a Dutch multicentre randomized controlled cross-over trial.

There is a need for prospective multicentre randomized controlled trials (RCTs) on interventions for the treatment of ABCs.

Methods: A decision tree model was created and parameterized using data from a single-centre randomized controlled trial, augmented with institutional cost data.

Therefore, our single-centre randomized controlled trial evaluated the benefits of this approach versus the posterolateral approach.

Methods This was a single-centre randomized controlled trial of adults with high anal fistula comparing FSR with VAAFT.

Aims A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care.

A multicentre randomized controlled trial was performed comparing Glubran 2 to standard of care absorbable tacks, particularly assessing chronic postoperative inguinal pain and its effects.

TRIAL DESIGN Two-arm parallel-group single-centre randomized controlled trial (RCT).

METHODS We analyzed data of patients with a posterior circulation stroke who were included in the Multicentre Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry between March 2014 and December 2018, a prospective, nationwide study, in which data were collected from consecutive patients who underwent endovascular treatment for ischemic stroke in the Netherlands.

We aimed to explore the potential predictors and moderators of outcome in a large multicentre randomized controlled trial comparing TD-GCBT plus treatment as usual (TAU) to TAU alone.

In patients with acute and chronic coronary syndromes, multicentre randomized controlled trials in >11 000 patients followed for up to 5 years demonstrated that colchicine may reduce the risk of CV death, myocardial infarction, ischaemic stroke and ischaemia-driven revascularization by >30% (RR 0.

0123456789();: Nature reviews | Rheumatology The results of R4RA, the first biopsydriven, multicentre randomized controlled trial (RCT) in rheumatoid arthritis (RA), suggest that direct assessment of synovial tissue pathology could be used to guide the choice of treatment for patients with RA.

DESIGN A multi-centre randomized controlled trial will be used.

METHODS This multicentre randomized controlled trial (RCT) will recruit 360 patients within 3 to 6 months after arthroscopic knee surgery with a magnetic resonance imaging (MRI)-confirmed arthrofibrosis to prove non-inferiority of MUA.

This multicentre randomized controlled trial compares clinical and functional outcomes between transurethral resection of the prostate (TURP) and thulium laser vaporesection of the prostate (ThuVARP), with an embedded qualitative and economic evaluation.

26, values from the CORRECT trial, a multi-centre randomized placebo-controlled phase III study for regorafenib in mCRC, were used.

Methods: MASTERPLAN is an investigator-initiated prospective multi-centre randomized phase II trial.

Aims Using tibial shaft fracture participants from a large, multicentre randomized controlled trial, we investigated if patient and surgical factors were associated with health-related quality of life (HRQoL) at one year post-surgery.

Methods: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) was a multicentre randomized clinical trial comparing reamed and nonreamed intramedullary nailing on rates of reoperation to promote fracture union, treat infection or preserve the limb in patients with open and closed fractures of the tibial shaft.

Methods A total of 1404 primary tumour radiomic features were extracted from pre-treatment [ 18 F]fluorodeoxyglucose (FDG)-PET scans of stage IIIA/N2 or IIIB NSCLC patients using a training cohort ( n  = 79; prospective Swiss multi-centre randomized phase III trial SAKK 16/00; 16 centres) and an internal validation cohort ( n  = 31; single centre).

Parallel two-group prospective multicentre randomized trial named “HYD45 — Hydration in CKD 4–5 stages” that enrolled 62 patients with CKD G4–5 was aimed at evaluating of estimated glomerular filtration rate (eGFR) with coaching to increase water intake (CIWI) with the achievement of minimally higher diuresis by 400 mL in 31 patients compared with the CKD G4–5 group without CIWI.

(2) Methods: This is a 13-week unblinded, single-centre randomized feasibility study.

DESIGN Multi-centre randomized controlled trial.

The present study was based on a post hoc analysis of the CIRCUS trial database, a multicentre randomized study which gathered 969 patients with anterior STEMI treated by primary percutaneous intervention (PPCI) within 12 hours of symptoms onset.

We performed an international multicentre randomized controlled trial (NTR: 4487) in patients aged 8-18 years with IBD and anaemia (defined as Hb > 2 standard deviations (SD) below the reference mean according to WHO cut-offs).

METHODS AND RESULTS  Single-centre randomized controlled trial of patients admitted to the emergency department due to ACPO with hypoxemia and dyspnoea on face mask oxygen therapy.

Methods We conducted a prospective, pragmatic multicentre randomized controlled trial in 335 HD patients and randomly (1:1) assigned them to either (i) intradialytic exercise training plus usual care maintenance HD or (ii) usual care maintenance HD.

In this multicentre randomized controlled trial, 134 patients aged 10–17 years with moderate-to-severe psoriasis requiring systemic therapy were randomized 2 : 1 to receive fumaric acid esters (FAE) or placebo for 20 weeks, followed by an open-label FAE phase.