Browsing by Subject "clinical trial"

Now showing 1 - 4 of 4

Open Access
Six-minute walk distance after coronary artery bypass grafting compared with medical therapy in ischaemic cardiomyopathy.
(Open heart, 2018-01) Stewart, Ralph AH; Szalewska, Dominika; Stebbins, Amanda; Al-Khalidi, Hussein R; Cleland, John GH; Rynkiewicz, Andrzej; Drazner, Mark H; White, Harvey D; Mark, Daniel B; Roy, Ambuj; Kosevic, Dragana; Rajda, Miroslaw; Jasinski, Marek; Leng, Chua Yeow; Tungsubutra, Wiwun; Desvigne-Nickens, Patrice; Velazquez, Eric J; Petrie, Mark C
In patients with ischaemic left ventricular dysfunction, coronary artery bypass surgery (CABG) may decrease mortality, but it is not known whether CABG improves functional capacity.To determine whether CABG compared with medical therapy alone (MED) increases 6 min walk distance in patients with ischaemic left ventricular dysfunction and coronary artery disease amenable to revascularisation.The Surgical Treatment in Ischemic Heart disease trial randomised 1212 patients with ischaemic left ventricular dysfunction to CABG or MED. A 6 min walk distance test was performed both at baseline and at least one follow-up assessment at 4, 12, 24 and/or 36 months in 409 patients randomised to CABG and 466 to MED. Change in 6 min walk distance between baseline and follow-up were compared by treatment allocation.6 min walk distance at baseline for CABG was mean 340±117 m and for MED 339±118 m. Change in walk distance from baseline was similar for CABG and MED groups at 4 months (mean +38 vs +28 m), 12 months (+47 vs +36 m), 24 months (+31 vs +34 m) and 36 months (-7 vs +7 m), P>0.10 for all. Change in walk distance between CABG and MED groups over all assessments was also similar after adjusting for covariates and imputation for missing values (+8 m, 95% CI -7 to 23 m, P=0.29). Results were consistent for subgroups defined by angina, New York Heart Association class ≥3, left ventricular ejection fraction, baseline walk distance and geographic region.In patients with ischaemic left ventricular dysfunction CABG compared with MED alone is known to reduce mortality but is unlikely to result in a clinically significant improvement in functional capacity.NCT00023595.
Open Access
The impact of lowering the study design significance threshold to 0.005 on sample size in randomized cancer clinical trials.
(Journal of clinical and translational science, 2024-01) Leung, Tiffany H; Ho, James C; Wang, Xiaofei; Lam, Wendy W; Pang, Herbert H
The proposal of improving reproducibility by lowering the significance threshold to 0.005 has been discussed, but the impact on conducting clinical trials has yet to be examined from a study design perspective. The impact on sample size and study duration was investigated using design setups from 125 phase II studies published between 2015 and 2022. The impact was assessed using percent increase in sample size and additional years of accrual with the medians being 110.97% higher and 2.65 years longer respectively. The results indicated that this proposal causes additional financial burdens that reduce the efficiency of conducting clinical trials.
Open Access
The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD.
(Translational journal of the American College of Sports Medicine, 2018-03) Hall, Katherine S; Morey, Miriam C; Beckham, Jean C; Bosworth, Hayden B; Pebole, Michelle M; Pieper, Carl F; Sloane, Richard
Posttraumatic stress disorder (PTSD) affects up to 30% of military veterans. Older veterans, many of whom have lived with PTSD symptoms for several decades, report a number of negative health outcomes. Despite the demonstrated benefits of regular exercise on physical and psychological health, no studies have explored the impact of exercise in older veterans with PTSD. This paper describes the development, design, and implementation of the Warrior Wellness exercise pilot study for older veterans with PTSD. Veterans aged ≥60 with a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of PTSD will be recruited and randomized to (a) Warrior Wellness, a 12-week supervised, facility-based exercise intervention, or (b) usual care for 12 weeks. Warrior Wellness is a theory- and evidence-based behavioral intervention that involves 3 sessions per week of multi-component exercise training that targets strength, endurance, balance, and flexibility. Warrior Wellness focuses on satisfaction with outcomes, self-efficacy, self-monitoring, and autonomy. Factors associated with program adherence, defined as the number of sessions attended during the 12 weeks, will be explored. Primary outcomes include PTSD symptoms and cardiovascular endurance, assessed at baseline and 12 weeks. Compared to those in usual care, it is hypothesized that those in the Warrior Wellness condition will improve on these efficacy outcomes. The Warrior Wellness study will provide evidence on whether a short-term exercise intervention is feasible, acceptable, and effective among older veterans with PTSD, and explore factors associated with program adherence. ClinicalTrials.gov Identifier: NCT02295995.
Open Access
Treatment-Related Adverse Events of Chimeric Antigen Receptor T-Cell (CAR T) in Clinical Trials: A Systematic Review and Meta-Analysis.
(Cancers, 2021-08-03) Lei, Wen; Xie, Mixue; Jiang, Qi; Xu, Nengwen; Li, Ping; Liang, Aibin; Young, Ken H; Qian, Wenbin
Chimeric antigen receptors T (CAR-T) cell therapy of cancer is a rapidly evolving field. It has been shown to be remarkably effective in cases of hematological malignancies, and its approval by the FDA has significantly increased the enthusiasm for wide clinical usage and development of novel CAR-T therapies. However, it has also challenged physicians and investigators to recognize and deal with treatment-associated toxicities. A total of 2592 patients were included from 84 eligible studies that were systematically searched and reviewed from the databases of PubMed, de, the American Society of Hematology and the Cochrane Library. The meta-analysis and subgroup analysis by a Bayesian logistic regression model were used to evaluate the incidences of therapy-related toxicities such as cytokine release syndrome (CRS) and neurological symptoms (NS), and the differences between different targets and cancer types were analyzed. The pooled all-grade CRS rate and grade ≥ 3 CRS rate was 77% and 29%, respectively, with a significantly higher incidence in the hematologic malignancies (all-grade: 81%; grade ≥ 3: 29%) than in solid tumors (all-grade: 37%; grade ≥ 3: 19%). The pooled estimate NS rate from the individual studies were 40% for all-grade and 28% for grade ≥ 3. It was also higher in the hematologic subgroup than in the solid tumors group. The subgroup analysis by cancer type showed that higher incidences of grade ≥ 3 CRS were observed in anti-CD19 CAR-T therapy for ALL and NHL, anti-BCMA CAR-T for MM, and anti-CEA CAR-T for solid tumors, which were between 24-36%, while higher incidences of grade ≥ 3 NS were mainly observed in CD19-ALL/NHL (23-37%) and BCMA-MM (12%). Importantly, subgroup analysis on anti-CD19 CAR-T studies showed that young patients (vs. adult patients), allologous T cell origin (vs. autologous origin), gamma retrovirus vector, and higher doses of CAR-T cells were associated with high-grade CRS. On the other hand, the patients with NHL (vs ALL), administered with higher dose of CAR-T, and adult patients (vs. young patients) had an increased incidence of grade ≥ 3 NS events. This study offers a comprehensive summary of treatment-related toxicity and will guide future clinical trials and therapeutic designs investigating CAR T cell therapy.