Investigation on Colchicine for Acute Pericarditis: a multicenter randomized placebo-controlled trial evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of pericarditis; study design amd rationale

Abstract Increased physical activity can have health benefits among inactive individuals. In Sweden, the healthcare system uses physical activity on prescription (PAP) to motivate patients to increase their physical activity level. Mindfulness may further heighten the internal motivation to engage in physical activity. However, previous research has not demonstrated clear evidence of such an association. Aim Examine the feasibility of the study design as a preparation for a full-scale study, and examine the differences, between three interventions, in change over time in physical activity levels and in related variables. Method Comparison between three different interventions in an ordinary primary health care setting: PAP, mindfulness, and a combination of PAP and mindfulness. Physical activity was measured with self-report and ACTi Graph GT1X activity monitor. Statistical analysis was performed with a mixed-effect model to account for repeated observations and estimate differences both within groups and between groups at 3- and 6-months follow-up. Results Between September 2016 and December 2018, a total of 88 participants were randomised into three groups. The total dropout rate was 20.4%, the attendance rate to the mindfulness courses (52% > 6 times) and the web-based mindfulness training (8% > 800 min) was low according to the stated feasibility criteria. Eleven participants were excluded from analysis due to low activity monitor wear time. Neither the activity monitor data nor self-reported physical activity showed any significant differences between the groups. Conclusion The study design needs adjustment for the mindfulness intervention design before a fully scaled study can be conducted. A combination of PAP and mindfulness may increase physical activity and self-rated health more than PAP or mindfulness alone. Trial registration ClinicalTrials.gov, registration number NCT02869854. Regional Ethical Review Board in Lund registration number 2016/404.

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Sitagliptin on carotid intima-media thickness in type 2 diabetes and hyperuricemia patients: a subgroup analysis of the PROLOGUE study

Therapeutic Advances in Chronic Disease ◽

10.1177/20406223211026993 ◽

2021 ◽

Vol 12 ◽

pp. 204062232110269

Author(s):

Yipin Zhao ◽

Huawei Wang ◽

Dazhi Ke ◽

Wei Deng ◽

Yingying Ji ◽

...

Keyword(s):

Type 2 Diabetes ◽

Carotid Artery ◽

Conventional Therapy ◽

Therapy Group ◽

Controlled Trial ◽

Intima Media Thickness ◽

Carotid Intima Media Thickness ◽

Media Thickness ◽

Significant Difference

Background and Aims: Studies have shown that dipeptidyl peptidase-4 (DDP-4) inhibitors have anti-atherosclerotic effects. However, in the PROLOGUE study, sitagliptin failed to slow the progression of carotid intima-media thickness (CIMT) relative to conventional therapy. We conducted a post hoc analysis of the PROLOGUE study and compared the effects of sitagliptin and conventional therapy on changes in CIMT in subgroups with or without hyperuricemia. Methods: The PROLOGUE study was a randomized controlled trial of 442 patients with type 2 diabetes mellitus (T2DM). Patients were randomized to receive sitagliptin added therapy or conventional therapy. Based on the serum uric acid levels of all study populations in the PROLOGUE study, we divided them into hyperuricemia subgroup ( n = 104) and non-hyperuricemia subgroup ( n = 331). The primary outcome was changed in carotid intima-media thickness (CIMT) parameters compared with baseline during the 24 months treatment period. Results: In the hyperuricemia subgroup, compared with the conventional therapy group, the changes in the mean internal carotid artery (ICA)-IMT and max ICA-IMT at 24 months were significantly lower in the sitagliptin group [−0.233 mm, 95% confidence interval (CI) (−0.419 to 0.046), p = 0.015 and −0.325 mm, 95% CI (−0.583 to −0.068), p = 0.014], although there was no significant difference in the common carotid artery CIMT. Conclusion: The results of our analysis indicated that sitagliptin attenuated the progression of CIMT than conventional therapy in T2DM and hyperuricemia patients.

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Efficacy and Safety of Divaza for the Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial

Cerebrovascular Diseases ◽

10.1159/000515233 ◽

2021 ◽

pp. 1-11

Author(s):

Nataliia U. Lashch ◽

Pavel R. Kamchatnov ◽

Tatiana N. Fedorova ◽

Olga A. Muzychuk ◽

Kristina K. Khacheva ◽

...

Keyword(s):

Cognitive Impairment ◽

Placebo Group ◽

Study Design ◽

Therapeutic Option ◽

Controlled Trial ◽

Prospective Trial ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Cerebral Atherosclerosis ◽

Endogenous Antioxidant

Objective: The objective of this study was to determine if Divaza, a drug with nootropic and antioxidant effects, was safe and effective for the correction of oxidative disturbances and to stabilize cognitive impairment in patients with cerebral atherosclerosis. Study Design: The study design consisted of a 12-week multicenter, randomized, double-blind, placebo-controlled, prospective trial in parallel groups. Setting: The setting in which the study was conducted comprised 10 clinical centers across the Russian Federation. Interventions: Patients were randomized into 2 groups and instructed to take either 2 tablets of the study drug or a placebo 3 times per day in conjunction with basic therapy. Outcomes: The primary outcome was a change in the average endogenous antioxidant potential after the completion of the study. The blood indicators of the oxidative stress (OS) were analyzed at the baseline and then after 12 weeks of therapy using iron-induced chemiluminescence analysis. The Montreal cognitive assessment test was used as a secondary outcome measure to evaluate cognitive impairment at the end of the study. Results: 124 outpatients with a mean age of 60.7 ± 7.6 years were enrolled and randomly assigned to receive Divaza (n = 65) or a placebo (n = 59). An improvement of cognitive function was observed in all patients of the Divaza group at the end of the treatment; this was significantly better than the placebo group (100 [100] vs. 89.5 [89.1]%, respectively, p = 0.0272 [p = 0.0128]). The administration of Divaza restored the activity of the endogenous antioxidant system. The change in the average level of lipoprotein resistance to oxidation after 12 weeks of therapy, compared to the baseline, was significantly higher in the Divaza group (14.8 ± 14.7 [14.8 ± 14.7] seconds latent period vs. 6.4 ± 16.9 [6.9 ± 16.7] seconds in the placebo group (p = 0.007 [p = 0.0107]). Conclusions: Divaza is a safe and effective therapeutic option for attenuating OS and recovery of cognitive impairment in patients with cerebral atherosclerosis.

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Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

Trials ◽

10.1186/1745-6215-12-111 ◽

2011 ◽

Vol 12 (1) ◽

Cited By ~ 32

Author(s):

Sabrine NT Hemmes ◽

Paolo Severgnini ◽

Samir Jaber ◽

Jaume Canet ◽

Hermann Wrigge ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Abdominal Surgery ◽

General Anesthesia ◽

Study Design ◽

Controlled Trial ◽

Protective Ventilation ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Open Abdominal Surgery

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Documenting Patients’ and Providers’ Preferences When Proposing a Randomized Controlled Trial: A Qualitative Exploration

10.21203/rs.3.rs-294467/v1 ◽

2021 ◽

Author(s):

Devesh Oberoi ◽

Cynthia Kwok ◽

Yong Li ◽

Cindy Railton ◽

Susan Horsman ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Study Design ◽

Controlled Trial ◽

Primary Care Providers ◽

Referral Letter ◽

Care Providers ◽

Randomized Controlled ◽

Number Of Patients ◽

Follow Up Care

Abstract Background With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we sought to explore patients’ and OPs’ reactions to our proposed recruitment methods. Methods We used a qualitative study design with content analysis, and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial. Results OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers. Conclusion OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials.

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