| 11. |
- Prescott, Eva, et al.
(författare)
-
Design and rationale of FLAVOUR : A phase IIa efficacy study of the 5-lipoxygenase activating protein antagonist AZD5718 in patients with recent myocardial infarction
- 2020
-
Ingår i: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 19
-
Tidskriftsartikel (refereegranskat)abstract
- Patients with coronary artery disease remain at increased risk of recurrent life-threatening cardiovascular events even after adequate guideline-based treatment of conventional risk factors, including blood lipid levels. Inflammation is a critical pathway in the pathogenesis of atherosclerosis and is independently associated with risk of recurrent cardiovascular events. Leukotrienes are potent pro-inflammatory and vasoactive mediators synthesized by leukocytes in atherosclerotic lesions. AZD5718 is a novel antagonist of 5-lipoxygenase activating protein that suppresses leukotriene biosynthesis. FLAVOUR is a phase IIa efficacy and safety study of AZD5718 in patients with myocardial infarction 1–4 weeks before randomization. Stenosis of the left anterior descending coronary artery after percutaneous intervention must be <50%, and Thrombolysis In Myocardial Infarction flow grade must be ≥ 2. Enrolled participants receive standard care plus oral AZD5718 200 mg, 50 mg, or placebo once daily for up to 12 weeks (extended from 4 weeks by protocol amendment). The planned sample size is 100 participants randomized to 12 weeks’ treatment. Change in urine leukotriene E4 levels is the primary efficacy outcome. FLAVOUR also aims to evaluate whether AZD5718 can improve coronary microvascular function, as measured by transthoracic colour Doppler-assisted coronary flow velocity reserve. Centrally pretrained study sonographers use standardized protocols and equipment. Additional outcomes include assessment of comprehensive echocardiographic parameters (including coronary flow, global strain, early diastolic strain rate and left ventricular ejection fraction), arterial stiffness, biomarkers, health-related quality of life, and safety. Specific anti-inflammatory therapies may represent novel promising treatments to reduce residual risk in patients with coronary artery disease. By combining primary pharmacodynamic and secondary cardiovascular surrogate efficacy outcomes, FLAVOUR aims to investigate the mechanistic basis and potential benefits of AZD5718 treatment in patients with coronary artery disease.
|
|
| 12. |
|
|
| 13. |
- Rezk, Francis, et al.
(författare)
-
Incisional negative pressure wound therapy for the prevention of surgical site infection after open lower limb revascularization – Rationale and design of a multi-center randomized controlled trial
- 2019
-
Ingår i: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 16
-
Tidskriftsartikel (refereegranskat)abstract
- Introduction: Lower limb revascularization with inguinal incisions is a common vascular surgical procedure. Due to risk of injury to lymphatic vessels and a diverse bacterial flora in the groin, surgical site infections (SSI) represent a common and sometimes life-threatening complication. While transverse incisions in endovascular aneurysm repair has a low SSI rate, vertical incisions in thrombendarterectomy (TEA) has a higher risk and bypass the highest risk. This randomized controlled trial (RCT) will investigate the protective role of negative pressure wound therapy (NPWT) on closed inguinal incisions in elective vascular surgery undergoing TEA and bypass procedures, respectively, to prevent SSI. Methods: This RCT registered at ClinicalTrials.gov (Identifier: NCT01913132) compares the effects of a NPWT dressing (PICO™, Smith & Nephew, UK) to standard wound dressing on postoperative SSI. The multi-center study includes two distinct vascular procedures with different SSI risk profiles: TEA and lower limb bypass. Three hundred and fifty-eight groin incisions are anticipated to be included in the TEA group and 133 inguinal incisions in the bypass group. Bilateral inguinal incisions will be randomized to NPWT in one groin and control dressing in the contralateral groin, and this dependency was accounted for in sample size calculation and will be addressed in data analysis. Discussion: This RCT attempts to evaluate the potential benefit of NPWT on closed inguinal incisions after two distinct vascular procedures at high risk of SSI. Outcome of this trial could have implications on postoperative wound care in both vascular and non-vascular surgical patients.
|
|
| 14. |
|
|
| 15. |
- Singh, Laura, et al.
(författare)
-
A first remotely-delivered guided brief intervention to reduce intrusive memories of psychological trauma for healthcare staff working during the ongoing COVID-19 pandemic : Study protocol for a randomised controlled trial
- 2022
-
Ingår i: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 26
-
Tidskriftsartikel (refereegranskat)abstract
- Addressing the mental health needs of healthcare staff exposed to psychologically traumatic events at work during the COVID-19 pandemic is a pressing global priority. We need to swiftly develop interventions to target the psychological consequences (e.g., persistent intrusive memories of trauma). Interventions for healthcare staff must be brief, flexible, fitted around the reality and demands of working life under the pandemic, and repeatable during ongoing/further trauma exposure. Intervention delivery during the pandemic should be remote to mitigate risk of infection; e.g., here using a blend of digitalized self-administered materials (e.g., video instructions) and guided (remote) support from a researcher. This parallel groups, two-arm, randomised controlled trial (RCT) with healthcare staff working during the COVID-19 pandemic is the first evaluation of whether a digitalized form of a brief cognitive task intervention, which is remotely-delivered (guided), reduces intrusive memories. Healthcare staff who experience intrusive memories of work-related traumatic event(s) during the COVID-19 pandemic (≥2 in the week before inclusion) will be randomly allocated (1:1) to receive either the cognitive task intervention or an active (attention placebo) control, and followed up at 1-week, 1-month, 3-months, and 6-months post-intervention. The primary outcome will be the number of intrusive memories reported during Week 5; secondary and other outcomes include the number of intrusive memories reported during Week 1, and other intrusive symptoms. Findings will inform further development and dissemination of a brief cognitive task intervention to target intrusive memories.
|
|
| 16. |
- Söderström, Hanna, et al.
(författare)
-
Does a gluten-free diet lead to better glycemic control in children with type 1 diabetes? : Results from a feasibility study and recommendations for future trials
- 2022
-
Ingår i: Contemporary Clinical Trials Communications. - : Elsevier. - 2451-8654. ; 26
-
Tidskriftsartikel (refereegranskat)abstract
- Background: Increasing evidence suggests a link between type 1 diabetes (T1D) and intake of gluten, but no controlled trials have examined whether a gluten-free diet (GFD) has positive effects on glycemic control in children with T1D. Methods: We conducted a non-randomized feasibility study. Twenty-three children with newly diagnosed T1D were included and either followed a GFD (n = 14) or a normal diet (n = 9) for 12 months. Effects of diet on glycemic control were examined by measuring insulin production (c-peptide), hemoglobine A1c (HbA1c) and insulin dose adjusted A1c (IDAA1c). Degree of adherence to the GFD and effects on quality of life were also examined. Results: Children on a GFD showed a statistically significantly lower HbA1c at six months (P = 0.042) compared with children on a normal diet and point estimate differences indicated better glycemic control in the GFD group at 6 and 12 months. Adherence to a GFD varied but was satisfactory for a majority of children. The GFD group reported poorer quality of life at inclusion and there was a non-significant difference for quality of life between groups throughout the study. Conclusions: A strict GFD can be maintained by children with newly diagnosed T1D and may have positive effects on glycemic control. Our findings should be interpreted carefully because of small samples and possible confounding. We provide recommendations for future trials and suggest using a randomized-controlled design with 30–40 participants in each arm.
|
|
| 17. |
- Taule, T., et al.
(författare)
-
Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen (ECAS) in Norway: Protocol for validation and a prospective cohort study
- 2019
-
Ingår i: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 14
-
Tidskriftsartikel (refereegranskat)abstract
- In amyotrophic lateral sclerosis (ALS) cognitive impairment may occur. This could detrimentally influence communication between patient and health-care professionals and make clinical assessment difficult. Given the short life expectancy after diagnosis, it is crucial to accurately identify ALS patients early. Although suitable cognitive screening tools for patients with ALS are available, they have not been evaluated in a Norwegian population. Interpretation of scores for available tests and practical application of scoring is also not well established. The protocol described here involves two related studies that aim to improve the quality of ALS clinical testing instruments used in the Norwegian population. The first is a validation study that evaluates the psychometric properties of the ECAS-Norwegian. The second is a prospective cohort study that evaluates the ECAS-Norwegian as a tool to predict early changes in ability to work, drive a car and the need for advanced therapy. Study 1 is a multicenter study using international quality criteria. Patients with ALS, healthy control subjects, and control subjects with dementia will be included. Primary outcome is ECAS-Norwegian scores. In study 2, patients with ALS will be included. ECAS-Norwegian compared to Clinical Dementia Rating score and Montreal Cognitive Assessment scores will be used as a prognostic tool for working, driving, and initiating advanced life-prolonging therapy. Before clinical implementation, the ECAS-Norwegian needs to be evaluated and validated. Successful validation and implementation of the ECAS-Norwegian may provide early identification of cognitive impairment in ALS, leading to more proactive, individualized treatment.
|
|
| 18. |
- Torres, Roxana, et al.
(författare)
-
Lifestyle modification intervention for overweight and obese Hispanic pregnant women : Development, implementation, lessons learned and future applications
- 2016
-
Ingår i: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 3, s. 111-116
-
Tidskriftsartikel (refereegranskat)abstract
- Objectives To describe the development, implementation and lessons learned of lifestyle intervention to promote appropriate gestational weight gain among Hispanic pregnant women. Design The intervention was informed by an empowerment oriented theoretical framework, and targeted women in the Pregnancy and Early Life Improvement Study. Methods The nutrition component consisted of recommendations for total calories, food quantity and improving carbohydrate and fat quality. We provided brown rice, omega-3 rich vegetable oil and spread, and water monthly. The physical activity focused on limiting sedentary behavior and promoting regular movement. The intervention was delivered through individual and group sessions and phone calls. Participants set their own goals, which were closely monitored. The intervention was evaluated extracting data from participant's record (attendance, goals, and challenges) and using a questionnaire. Results Participants were from underserved communities with economic, time, cultural and social barriers for engaging in lifestyle interventions. Modifications were done to facilitate participation, such as coordinating sessions with prenatal appointments and reducing group size and duration of sessions. Weekly text messages were added to reinforce the intervention. The main goal chosen by participants was reduction of sweetened beverages. The greatest challenges were replacing white rice with brown rice and improving physical activity. Participants suggested conducting sessions near their community and using social media as a motivation tool. Main outcomes results will be published elsewhere. Conclusion We identified barriers to delivering the lifestyle intervention, mainly related to group session's participation. Sessions should be conducted in the community, using text messages and social media as reinforcement. ClinicalTrials.gov: NCT01771133.
|
|
| 19. |
|
|
| 20. |
- Woodford, Joanne, et al.
(författare)
-
Study within a trial (SWAT) protocol. Investigating the effect of personalised versus non-personalised study invitations on recruitment : An embedded randomised controlled recruitment trial
- 2020
-
Ingår i: Contemporary Clinical Trials Communications. - : Elsevier. - 2451-8654. ; 18
-
Tidskriftsartikel (refereegranskat)abstract
- Introduction: Recruitment into clinical trials is a common challenge experienced by healthcare researchers. Currently, there is little evidence regarding strategies to improve recruitment into clinical trials. However, preliminary research suggests the personalisation of study invitation letters may increase recruitment rates. As such, there is a need to investigate the effectiveness of personalisation strategies on trial recruitment rates. This study within a trial (SWAT) will investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host trial ENGAGE, a feasibility study of an internet-administered, guided, Cognitive-Behavioural Therapy (CBT) based self-help intervention for parents of children previously treated for cancer.Methods: An embedded randomised controlled trial (RCT) will investigate the effectiveness of a personalised study invitation letter including the potential participant's name and address compared with a standard, non-personalised letter without name or address, on participant recruitment rates into the ENGAGE study. The primary outcome is differences in the proportion of participants recruited, examined using logistic regression. Results will be reported as adjusted odds ratios with 95% confidence intervals.Discussion: Even moderate effects of the personalisation of study invitation letters on recruitment rates could be of significant value by shortening study length, saving resources, and providing a faster answer to the clinical question posed by the study. This protocol can be used as a template for other researchers who wish to contribute to the evidence base for trial decision-making, by embedding a similar SWAT into their trial.Trial registration: ISRCTN 57233429; ISRCTN 18404129; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231).
|
|
