Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters
DiscussionResults from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections.Ethics and disseminationSir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023. (Source: Trials)
Source: Trials - April 10, 2024 Category: Research Source Type: clinical trials
A placebo-controlled, crossover trial to investigate the efficacy of tiotropium bromide or placebo added to usual care in stable symptomatic post-hematopoietic stem cell transplantation (HSCT) bronchiolitis obliterans syndrome (BOS)
This study was approved by the Research Ethics Committees of Imam Khomeini Hospital Complex, Tehran University of Medical Science. Recruitment started in September 2022, with 20 patients randomized. The treatment follow-up of participants with tiotropium is currently ongoing and is due to finish in April 2024. The authors will disseminate the findings in peer-reviewed publications, conferences, and seminar presentations.Trial registrationIranian Registry of Clinical Trial (IRCT) IRCT20200415047080N3. Registered on 2022 –07-12, 1401/04/21. (Source: Trials)
Source: Trials - April 6, 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
Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents
Conditions: Adolescent Idiopathic Scoliosis Interventions: Other: Home-based adapted physical activity program supervised by an APA teacher via individual video conference.; Other: First period of the home-based adapted physical activity program with an exercise booklet.; Other: Second period of the home-based adapted physical activity program with an exercise booklet. Sponsors: Association des Paralysees de France (APF); Fondation de France Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 16, 2024 Category: Research Source Type: clinical trials
Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children
DiscussionSPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste.Trial RegistrationThe development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35) and CONSORT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reportin...
Source: Trials - January 30, 2024 Category: Research Source Type: clinical trials
Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)
DiscussionThe statistical analysis for the ALBINO study was defined in detail in the study protocol and implemented in this statistical analysis plan published prior to any data analysis. This is in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines.Trial registrationClinicalTrials.gov NCT03162653. Registered on 22 May 2017. (Source: Trials)
Source: Trials - January 24, 2024 Category: Research Source Type: clinical trials
Efficacy and safety of heparin for sepsis-induced disseminated intravascular coagulation (HepSIC): study protocol for a multicenter randomized controlled trial
DiscussionThe HepSIC trial is to evaluate the efficacy and safety of UFH on sepsis-related DIC across different areas of China. The small dosage of UFH administration would offer a new potential approach for treating sepsis-related coagulation disorders.Ethics and disseminationEthical approval was granted by all the ethics committees of 20 participant centers. Results will be disseminated via peer-reviewed publications and presented at conferences.Trial registrationClinicalTrials.gov NCT02654561. Registered on 13 January 2016. (Source: Trials)
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials
Effect of transvaginal Lactobacillus supplementation on reversing lower genital tract dysbiosis and improving perinatal outcomes in PCOS patients after IVF-FET: a study protocol for a multicenter randomized controlled trial
DiscussionThis is the first large and multicenter randomized controlled trial aimed at assessing the efficacy of transvaginalLactobacillus supplementation on restoring the LGT microbiome and improving perinatal outcomes in PCOS patients after IVF-FET. This pragmatic trial is promising for increasing the rates of clinical pregnancy and live birth in PCOS patients after IVF-FET.Ethics and disseminationEthical review approval was obtained from the Medical Research Ethics Committees of the International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University (15 October 2020, GKLW 2020-29). To maximize disse...
Source: Trials - December 21, 2023 Category: Research Source Type: clinical trials
Comparison of different intervention methods to reduce the incidence of venous thromboembolism: study protocol for a cluster-randomized, crossover trial
This study aims to compare the efficacy of two low molecular weight heparin (LMWH) regimens and additional intermittent pneumatic compression in preventing VTE among orthopedic trauma patients.Methods and analysisThis is a cluster-randomized crossover clinical study conducted in four hospitals in Shanghai from December 2019 to December 2023. The unit of randomization is orthopedic wards, and each ward will define a cluster. All clusters will implement four diverse intervention measures and one control measure in a given random sequence. Perioperative orthopedic trauma patients aged ≥ 18 years with stable vital signs, Cap...
Source: Trials - December 19, 2023 Category: Research Source Type: clinical trials
Improving Uptake of Pediatric Vaccines Through Religious Conferences and Vaccines-in-a-van in Aceh, Indonesia
Conditions: Vaccination Interventions: Behavioral: Religious conferences; Behavioral: Vaccine-in-a-van Sponsors: University of Michigan Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 7, 2023 Category: Research Source Type: clinical trials
A prospective, single-centre, randomized, double-blind controlled study protocol to study whether long-term oral metronidazole can effectively reduce the incidence of postoperative liver metastasis in patients with colorectal cancer
This study is a prospective, single-centre, randomized, double-blind controlled study in which 300 patients will be randomly assigned to the test group or the control group in a 1:1 allocation ratio. The aim of this trial is to demonstrate that long-term oral antibiotics can effectively reduce the incidence of postoperative liver metastasis in patients with colorectal cancer.Ethics and disseminationEthics approval was obtained from the Ethics Committee at the Chinese Ethics Committee of Registering Clinical Trials (ChiECRCT20210229). The results of this study will be disseminated at several research conferences and as publ...
Source: Trials - December 4, 2023 Category: Research Source Type: clinical trials
The effect of switch therapy to tenofovir versus entecavir maintenance on recurrence of hepatocellular carcinoma after surgery (SWITE): study protocol for a randomized controlled trial
AbstractBackgroundAntiviral therapy has been reported to be associated with lower recurrence rate of hepatocellular carcinoma (HCC) for patients with hepatitis B virus (HBV) infection. While entecavir (ETV) and tenofovir disoproxil fumarate (TDF) were both recommended as first-line therapies for HBV patients, recent retrospective studies proposed a lower incidence rate of HCC occurrence or recurrence in those receiving TDF compared ETV. However, the survival benefits of switching to TDF therapy after prolonged ETV treatment before surgery remain uncertain. We delineate the rationale and design of SWITE, a randomized, open-...
Source: Trials - December 2, 2023 Category: Research Source Type: clinical trials
Decreasing consumption of sugar-sweetened beverages and Raising tap water consumption through Interventions based on Nutrition and sustainability for Kids: study protocol of the “DRINK” cluster randomised controlled trial
The objective of this cluster randomised controlled trial is to evaluate the long-term effectiveness of nutrition- and environmental sustainability-based interventions on the reduction in SB intake and on the increase in tap water consumption in 3rd to 6th grade primary school children (8 to 11 years of age).MethodsForty-eight French-speaking Belgian primary schools (equivalent to around 3500 pupils involved in the evaluation) are randomised using a factorial plan: (i) control, (ii) nutrition-based intervention, (iii) sustainability-based intervention, and (iv) both. The interventions (encouragement of water breaks; prov...
Source: Trials - September 26, 2023 Category: Research Source Type: clinical trials
Maternal Mental Health Access - MaMa
Discussion board (DB); Behavioral: Arm 2; Behavioral: On Demand (OD) + Video Conference (VC); Behavioral: Arm 3 Sponsors: University of Utah; National Institute of Nursing Research (NINR) Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 22, 2023 Category: Research Source Type: clinical trials
