Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)
ConclusionsThe SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline.Trial registrationEQUATOR Network – Guidelines Under Development (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT). Registered on 25 March 2021. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials

Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10 –17-year-olds presenting at police custody: a randomised controlled trial
DiscussionThis two-arm individually RCT will evaluate the effectiveness of SFBT in reducing offending behaviours in CYP presenting at police custody suites within the area served by LSCFT. Our process evaluation will assess the fidelity of delivery of SFBT, the factors affecting implementation, the acceptability of SFBT in CYP aged 10 –17 years and recruitment and reach. We will also examine systems and structures for future delivery, therefore assessing overall scalability.Trial registrationClinicalTrials.gov  ISRCTN14195235. Registered on June 16, 2023. (Source: Trials)
Source: Trials - March 2, 2024 Category: Research Source Type: clinical trials

Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients
This study protocol describes the methodology, aiming to develop a core outcome set for perioperative exercise intervention trials for lung cancer in clinical practice.MethodsThe project will follow the standard methodology recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, which is divided into four steps. Stage I: Conducting a scoping review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains. Stage II: Conducting semi-structured interviews to obtain important outcomes for patients. Stage III: Choosing the most important outcomes by conduc...
Source: Trials - March 1, 2024 Category: Research Source Type: clinical trials

Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a statistical analysis plan for the ProMPT-2 randomised controlled trial
DiscussionThis manuscript prospectively describes, prior to the completion of data collection and database lock, the analyses to be undertaken for the ProMPT-2 trial to reduce risk of reporting and data-driven analyses.Trial registrationISRCTN ISRCTN15255199. Registered on 26 March 2019. (Source: Trials)
Source: Trials - February 29, 2024 Category: Research Source Type: clinical trials

National Robotics-Assisted Radical Prostatectomy Database
Conditions: Database; Prostate Cancer; Robotic-assisted Radical Prostatectomy; Surgical Outcomes; Oncological Outcomes; Patient Reported Outcome Measures; Learning Curve Sponsors: Melbourne Health; Peter MacCallum Cancer Centre, Australia; Epworth Healthcare; St Vincent ' s Hospital; Austin Health Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 28, 2024 Category: Research Source Type: clinical trials

Facilitating Safe Transition to Home for Preterm Infants - a National Database Study
Conditions: Premature Birth Sponsors: University Hospitals of Derby and Burton NHS Foundation Trust Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 28, 2024 Category: Research Source Type: clinical trials

Evaluation of SkillTalk for Autistic Young Adults
Conditions: Autism Spectrum Disorder Interventions: Other: SkillTalk for Autistic Young Adults; Other: Flyer Library Sponsors: dfusion Inc Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 28, 2024 Category: Research Source Type: clinical trials

Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer
Conditions: Biliary Tract Diseases; Gallbladder Cancer; Gallbladder Neoplasms Interventions: Other: no interventions Sponsors: RenJi Hospital Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 23, 2024 Category: Research Source Type: clinical trials

Chinese Obesity and MEtabolic Surgery Database (COMES Database)
Conditions: Obesity; Metabolic Surgery; Bariatric Surgery; Weight Loss Interventions: Procedure: Metabolic and Bariatric Surgery Sponsors: Jinan University Guangzhou; Chinese Obesity and Metabolic Surgery Collaborative Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 23, 2024 Category: Research Source Type: clinical trials

Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial
ConclusionIn this paper, we describe the detailed statistical analysis plan (SAP) for the TIPS trial, which was prepared prior to database lock. The SAP includes details of planned analyses and unpopulated tables, which will be reported in the publications. We plan to lock the database in July 2023 and publish the results later in the same year.SAP Version 0.1 (dated: 28 April 2023)Protocol version:2.0Trial registrationClinical Trial Registry of India CTRI/2019/02/017464. Registered on 5 February 2019;https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29764&EncHid=&userName=2019/02/017464 (Source: Trials)
Source: Trials - February 22, 2024 Category: Research Source Type: clinical trials

Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database Analysis
Conditions: Heart Failure; Cancer, Therapy-Related Interventions: Drug: Cancer therapy with FDA and/or EMA approval on the 31st March 2022 Sponsors: University Hospital, Caen Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 20, 2024 Category: Research Source Type: clinical trials

Venous Thrombo-Embolism Imaging Database (VTE-ID)
Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism Sponsors: University Hospital, Brest Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 14, 2024 Category: Research Source Type: clinical trials

Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
Conditions: Pertussis (Whooping Cough) Interventions: Other: Not applicable / database analysis Sponsors: Sanofi Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 14, 2024 Category: Research Source Type: clinical trials

Bronx Transthyretin Amyloid Cardiomyopathy Database
Conditions: Transthyretin Cardiac Amyloidosis; Transthyretin Amyloid Cardiomyopathy Interventions: Diagnostic Test: 99mTc-pyrophosphate Single Photon Emission Computed Tomography Sponsors: Montefiore Medical Center Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 14, 2024 Category: Research Source Type: clinical trials

Creation of a Clinical Database of Lumbar Spine MRI
Conditions: Low Back Pain Interventions: Other: Data Collection Sponsors: Caerus Medical; Centre hospitalier de l ' Universit é de Montréal (CHUM) Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 8, 2024 Category: Research Source Type: clinical trials