scholarly journals Protocol update and statistical analysis plan for CADENCE-BZ: a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Carmen Lim ◽  
◽  
Andrea Baker ◽  
Sukanta Saha ◽  
Sharon Foley ◽  
...  
2018 ◽  
Vol 14 (5) ◽  
pp. 555-558 ◽  
Author(s):  
Craig S Anderson ◽  
Mark Woodward ◽  
Hisatomi Arima ◽  
Xiaoying Chen ◽  
Richard I Lindley ◽  
...  

Background The ENhanced Control of Hypertension And Thrombolysis strokE study (ENCHANTED) trial was initiated as a 2 × 2 partial-factorial active-comparison, prospective, randomized, open, blinded endpoint clinical trial to evaluate in thrombolysis-eligible acute ischemic stroke (AIS) patients whether: (1) Arm A – low-dose (0.6 mg/kg body weight) intravenous (iv) alteplase has noninferior efficacy and lower risk of symptomatic intracerebral hemorrhage (sICH) compared with standard-dose (0.9 mg/kg body weight) iv alteplase; and (2) Arm B – early intensive blood pressure (BP) lowering (systolic target 130–140 mmHg) has superior efficacy and lower risk of ICH compared with guideline-recommended BP control (systolic target <180 mmHg). Arm A was completed in 2016; Arm B is now concluding. Objective To outline in detail and make public the predetermined statistical analysis plan (SAP) for the ‘BP control’ arm of this study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be outlined, and for each item, statistically relevant descriptive elements will be described. For the trial outcomes, the most appropriate statistical comparisons to be made between groups are planned and described. Results A SAP was developed for the results of the BP control arm of this study that is transparent, available to the public, verifiable, and predetermined before completion of data collection. Conclusions We have developed a predetermined SAP for the ENCHANTED BP control arm to be followed to avoid analysis bias arising from prior knowledge of the study findings. Clinical trial registration ClinicalTrials.gov (NCT01422616); ISRCTN Register (ISRCTN82387104); Australian New Zealand Clinical Trial Registry (ACTRN12611000236998); EU Clinical Trials Register (2011-005545-12); and Clinical Trials Registry – India (REF/2017/05/014334).


2015 ◽  
Vol 09 (03) ◽  
pp. 340-345 ◽  
Author(s):  
Shaam Saeed ◽  
Nada Bshara ◽  
Juliana Trak ◽  
Ghiath Mahmoud

ABSTRACT Objectives: To study the effect of water, halloumi cheese and sugar-free (SF) chewing gum on plaque pH recovery after the intake of sweetened PLAs. Settings and Design: A randomized clinical trial was conducted on 17 children (10 females, 7 males) aged 11–12 years with DFT/dft of more than 3. Materials and Methods: Each volunteer tested paracetamol and ibuprofen suspension alone or followed with water, halloumi cheese or SF gum, as well as 10% sucrose and 10% sorbitol as controls. Plaque pH was measured using the sampling method before and after 5, 10, 15, 20, 30 min of ingestion. Statistical Analysis: Statistical analysis was performed using analysis of variance followed by least significant difference test to assess minimum pH (min pH), maximum pH drop (ΔpH), and the area under baseline pH, and P value was set as 0.05. Results: Both ibuprofen and paracetamol were not significantly different from 10% sucrose in terms of min pH, ΔpH, and area under baseline pH except for min pH of ibuprofen (P = 0.034). Water and halloumi cheese did not have a significant effect on plaque pH recovery after the intake of both analgesics as min pH, ΔpH, and area under baseline pH were similar to 10% sucrose except for min pH of ibuprofen + water (P = 0.048). However, plaque pH variables after chewing SF gum for 20 min were similar to 10% sorbitol. Conclusion: Chewing SF gum immediately after the intake of sweetened PLAs for 20 min restores plaque pH and could be recommended as a complementary aid in caries prevention.


2020 ◽  
Vol 22 (2) ◽  
pp. 133-141
Author(s):  
Alexis P Poole ◽  
◽  
Mark E Finnis ◽  
James Anstey ◽  
Rinaldo Bellomo ◽  
...  

BACKGROUND: Contemporary glucose management of intensive care unit (ICU) patients with type 2 diabetes is based on trial data derived predominantly from patients without type 2 diabetes. This is despite the recognition that patients with type 2 diabetes may be relatively more tolerant of hyperglycaemia and more susceptible to hypoglycaemia. It is uncertain whether glucose targets should be more liberal in patients with type 2 diabetes. OBJECTIVE: To detail the protocol, analysis and reporting plans for a randomised clinical trial — the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial — which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A multicentre, parallel group, open label phase 2B randomised controlled clinical trial of 450 critically ill patients with type 2 diabetes. Patients will be randomised 1:1 to liberal blood glucose (target 10.0–14.0 mmol/L) or usual care (target 6.0–10.0 mmol/L). MAIN OUTCOME MEASURES: The primary endpoint is incident hypoglycaemia (< 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes. RESULTS AND CONCLUSION: The study protocol and statistical analysis plan described will delineate conduct and analysis of the trial, such that analytical and reporting bias are minimised. TRIAL REGISTRATION: This trial has been registered on the Australian New Zealand Clinical Trials Registry (ACTRN No. 12616001135404) and has been endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group.


2008 ◽  
Vol 29 (2) ◽  
pp. 95-101 ◽  
Author(s):  
Valérie Journot ◽  
Sophie Tabuteau ◽  
Fidéline Collin ◽  
Jean-Michel Molina ◽  
Geneviève Chene ◽  
...  

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