Contemporary Clinical Trials Communications最新文献

Curcumin supplementation combined with high intensity interval training modulates serum irisin and lipid profile in obese women: "A randomized double-blind clinical trial"

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-21 DOI: 10.1016/j.conctc.2025.101464

Bahram Jamali Gharakhanlou , Solmaz Babaei Bonab , Akram Amaghani , Mohammad Reza Shiri-Shahsavar

Background

Curcumin is the most widely known active substance of turmeric extract, which attributed numerous functional properties, including anti-inflammatory and cardioprotective properties. Inactivity and changes in lifestyle and subsequent overweight/obesity are becoming major health risk factors.

Objective

the aim of this study was to determine the effect of curcumin supplementation combined with high intensity interval trainings (HIIT) exercise on serum irisin and lipid profile in obese women.

Methods

40 inactive women (aged 30–35 years, and body mass index 30 and above) allocated in four groups (10 in each) as followed; curcumin (C), exercise plus curcumin (EC), placebo (P), and exercise plus placebo (EP). All subjects completed an eight-week HIIT program. The C and EC groups received one capsule containing 80 mg curcumin nanomicelle daily throughout study. Blood samples were taken in the beginning and after eight weeks to measure changes in the study variables (irisin and lipid profile). The ANCOVA and Bonferroni's post hoc test was used to compare variables between 4 groups and pairwise at a significance level of ≤0.05 using SPSS-22.

Results

The results revealed that mean serum irisin (p = 0.023), cholesterol (p = 0.019), triglyceride (p = 0.022), high-density lipoprotein (p = 0.009) and low-density lipoprotein (p = 0.011) were significantly changed in all intervention groups compared to the placebo group.

Conclusion

Based on these results, it can be concluded that HIIT training with curcumin consumption has a greater significancy on obesity reduction in women; Therefore, curcumin and HIIT exercise can be considered as a therapeutic approach to reduce the negative outcomes of obesity.

Clinical trial registry number

IRCT20141004019397N2, link.

Statement of significance

This study investigated the effects of curcumin supplementation combined with high-intensity interval training (HIIT) on human serum Irisin levels for the first time, in a clinical randomized trial. This suggests that HIIT training alongside curcumin consumption may be a promising therapeutic approach to reduce the negative health consequences of obesity in women.

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引用次数: 0

Investigation of the improvement of swallowing function with low-frequency pulse waves or interference waves delivered via cervical electrical stimulation in patients with Parkinson's disease: A randomized controlled study protocol

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-20 DOI: 10.1016/j.conctc.2025.101463

Masahiro Nakamori , Ryotaro Matsuyama , Megumi Toko , Hidetada Yamada , Yuki Hayashi , Kohei Yoshikawa , Mineka Yoshikawa , Toshikazu Nagasaki , Yoshitaka Shimizu , Hirofumi Maruyama

Parkinson's disease (PD) is associated with a high rate of swallowing dysfunction, which may lead to aspiration pneumonia. This randomized controlled trial aims to investigate the effects of cervical electrical stimulation interventions (interferential current or low-frequency pulse wave stimulation) on swallowing dysfunction in patients with PD. The study will include patients with PD with Hoehn–Yahr stages 2–4 and will assess the swallowing function in a multifaceted manner using tools such as the 1 % citric acid cough test, videofluoroscopic swallowing study (VFSS), Functional Oral Intake Scale score, and Eating Assessment Tool-10 score. The primary endpoint is an improvement in the cough reflex, as measured by the citric acid cough test, whereas the secondary endpoints include changes in the swallowing function, including the VFSS, tongue pressure, and salivary substance P levels. Participants will receive 30 min of cervical stimulation daily for 2 weeks. This study also explores the use of novel instruments such as multichannel surface electromyography and electronic stethoscopes for the detailed assessment of swallowing physiology. By investigating these two electrical stimulation techniques, this study seeks to provide insights into the pathophysiology of swallowing dysfunction in PD and to evaluate the efficacy and safety of these interventions.

Trial registration number

jRCTs062240041; pre-results.

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引用次数: 0

Operating characteristics of unequal allocation ratios in platform trials with the staggered addition of drugs using binary endpoints

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-17 DOI: 10.1016/j.conctc.2025.101450

Yosuke Shimizu , Ryoichi Hanazawa , Hiroyuki Sato , Akihiro Hirakawa

Background

One recommendation for the allocation ratio between multiple drugs and a shared placebo control group in platform trials (PTs) is to use a

\sqrt{k}

:1 allocation ratio for the placebo group relative to the drug group, where

k

is the number of drug groups with ongoing patient enrollment during the trials. However, the practical utility of such unequal allocation ratios in PTs lacks adequate study.

Methods

We compared the performances of equal and unequal allocation ratios through simulations to imitate practical PTs using only concurrent controls and binary endpoints for hospitalized patients with infectious diseases. The operating characteristics, including the type I error rate, power of hypothesis testing, and total sample size, were evaluated.

Results

In PTs, using an unequal allocation ratio (i) results in a considerable augmentation of the total sample size and prolongs the study duration when monthly patient enrollment is low, but (ii) the target power of hypothesis testing is often preserved compared to an equal allocation ratio, even when we incorrectly specify the drug and placebo group mortality rates assumed in the sample size calculation. The average power increase using an unequal allocation ratio relative to the equal allocation ratio per 100-patient increase in the placebo group was approximately 1.9 % in the selected scenarios of our simulation studies.

Conclusion

The results of the current study highlight the quantitative advantages and disadvantages of using unequal allocation ratios in PTs using only concurrent controls under the specific conditions assumed in our simulations and analyses.

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引用次数: 0

Participant recruitment and retention in randomised controlled trials of melanoma surveillance: A scoping review

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-16 DOI: 10.1016/j.conctc.2025.101461

Deonna M. Ackermann , Karen Bracken , Jolyn K. Hersch , Monika Janda , Robin M. Turner , Katy J.L. Bell

Background

This scoping review aims to collate and describe data on recruitment, retention, and strategies used to improve these, in randomised controlled trials of melanoma surveillance.

Methods

We searched MEDLINE, EMBASE, CINAHL and CENTRAL databases from inception until October 23, 2023. Two reviewers screened titles and abstracts, and full-texts, and one reviewer extracted data (convenience sample (n = 5) checked by a second). Eligibility criteria included: (i) RCT design, (ii) clinical setting, (iii) participants at increased risk of melanoma, (iv) interventions for early melanoma detection, and (v) early detection outcomes or surrogates such as improved skin self-examination. We calculated summary statistics and undertook qualitative data synthesis.

Results

From 1746 records, 21 trials (reported in 28 papers) were included. Recruitment sources included dermatology clinics, general practice sites, and hospital databases or registries. Trials reported proportions of those screened who were eligible (mean 75 %, range 24–100 %), proportions of those eligible who were randomised (mean 63 %, range 24–95 %), numbers randomised per month (mean 25 participants, range 2–74), and proportion of those randomised who completed outcome measurements (mean 85 %, range 59–100 %) for self-report questionnaires at primary timepoints). Recruitment strategies included targeted participant identification and flexible consent processes. Retention strategies included setting narrow eligibility criteria, reminders, and financial incentives. Reporting on strategies was limited and there were no reports on effectiveness. Few studies reported recruiter facing initiatives or public and patient involvement.

Discussion

More consistent and detailed reporting of recruitment and retention strategies in RCTs is needed, alongside evaluations of their effectiveness.

{"title":"Participant recruitment and retention in randomised controlled trials of melanoma surveillance: A scoping review","authors":"Deonna M. Ackermann , Karen Bracken , Jolyn K. Hersch , Monika Janda , Robin M. Turner , Katy J.L. Bell","doi":"10.1016/j.conctc.2025.101461","DOIUrl":"10.1016/j.conctc.2025.101461","url":null,"abstract":"<div><h3>Background</h3><div>This scoping review aims to collate and describe data on recruitment, retention, and strategies used to improve these, in randomised controlled trials of melanoma surveillance.</div></div><div><h3>Methods</h3><div>We searched MEDLINE, EMBASE, CINAHL and CENTRAL databases from inception until October 23, 2023. Two reviewers screened titles and abstracts, and full-texts, and one reviewer extracted data (convenience sample (n = 5) checked by a second). Eligibility criteria included: (i) RCT design, (ii) clinical setting, (iii) participants at increased risk of melanoma, (iv) interventions for early melanoma detection, and (v) early detection outcomes or surrogates such as improved skin self-examination. We calculated summary statistics and undertook qualitative data synthesis.</div></div><div><h3>Results</h3><div>From 1746 records, 21 trials (reported in 28 papers) were included. Recruitment sources included dermatology clinics, general practice sites, and hospital databases or registries. Trials reported proportions of those screened who were eligible (mean 75 %, range 24–100 %), proportions of those eligible who were randomised (mean 63 %, range 24–95 %), numbers randomised per month (mean 25 participants, range 2–74), and proportion of those randomised who completed outcome measurements (mean 85 %, range 59–100 %) for self-report questionnaires at primary timepoints). Recruitment strategies included targeted participant identification and flexible consent processes. Retention strategies included setting narrow eligibility criteria, reminders, and financial incentives. Reporting on strategies was limited and there were no reports on effectiveness. Few studies reported recruiter facing initiatives or public and patient involvement.</div></div><div><h3>Discussion</h3><div>More consistent and detailed reporting of recruitment and retention strategies in RCTs is needed, alongside evaluations of their effectiveness.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101461"},"PeriodicalIF":1.4,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143438056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A framework for upskilling the clinical trial site: Learnings from a clinical trial coordinator workforce capability building pilot program

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-15 DOI: 10.1016/j.conctc.2025.101460

Thobekile Mthethwa-Pitt , Prudence Perry , Jhodie Duncan , Felicity Osmond , Anne Woollett

Aim

This paper describes a simple education model for health service organisations engaging in clinical trials. Clinical trial coordinators (CTCs) are essential to operations of the clinical trial workforce; however, there is significant disparity in their skills and knowledge. The TrialHub upskilling pilot program is a novel, multimodal upskilling initiative which aims to develop an innovative clinical trial education framework to build consistent standards across the workforce, irrespective of site location and maturity.

Method

The upskilling pilot program was implemented across 7 health service organisations with varying levels of clinical trial maturity. The program adopted a stepwise engagement approach, and incorporated elements including mentorship, in-house training program strategies, and ongoing professional development initiatives. This approach was guided by consultation at individual CTC level to health service organisation governance levels, enabling education programs driven by CTC needs and oversight strategies for upskilling standards at each site. Site activity engagement sessions were tracked to map the progress of upskilling element implementation, and informed on framework development.

Results

Over a 30-month period (January 2022 to June 2024) site engagement tracking indicated diverse needs at each site, aligned with varying levels of site maturity and evolving upskilling priorities and focus throughout the pilot period. These insights underscore a requirement for tailoring upskilling elements and education initiatives to sites’ specific circumstances and changing maturity during development. Subsequently an upskilling framework, informed by these program learnings, was established to guide future workforce development and growth needs.

Conclusion

Although limited by a small sample size, this pilot program has demonstrated the potential of a tailored multi-modal upskilling approach to provide valuable professional learning experiences in clinical trial coordination, and support clinical trial site capability development. Clinical trial sites adoption of upskilling programs requires harmonisation and structured support through adaptive implementation, as described by the CTC upskilling framework. Upskilling CTCs in parallel with increasing clinical trial site capability is required if sites are to be adequately mature, and be able to meet the growing demands of Australian communities.

{"title":"A framework for upskilling the clinical trial site: Learnings from a clinical trial coordinator workforce capability building pilot program","authors":"Thobekile Mthethwa-Pitt , Prudence Perry , Jhodie Duncan , Felicity Osmond , Anne Woollett","doi":"10.1016/j.conctc.2025.101460","DOIUrl":"10.1016/j.conctc.2025.101460","url":null,"abstract":"<div><h3>Aim</h3><div>This paper describes a simple education model for health service organisations engaging in clinical trials. Clinical trial coordinators (CTCs) are essential to operations of the clinical trial workforce; however, there is significant disparity in their skills and knowledge. The TrialHub upskilling pilot program is a novel, multimodal upskilling initiative which aims to develop an innovative clinical trial education framework to build consistent standards across the workforce, irrespective of site location and maturity.</div></div><div><h3>Method</h3><div>The upskilling pilot program was implemented across 7 health service organisations with varying levels of clinical trial maturity. The program adopted a stepwise engagement approach, and incorporated elements including mentorship, in-house training program strategies, and ongoing professional development initiatives. This approach was guided by consultation at individual CTC level to health service organisation governance levels, enabling education programs driven by CTC needs and oversight strategies for upskilling standards at each site. Site activity engagement sessions were tracked to map the progress of upskilling element implementation, and informed on framework development.</div></div><div><h3>Results</h3><div>Over a 30-month period (January 2022 to June 2024) site engagement tracking indicated diverse needs at each site, aligned with varying levels of site maturity and evolving upskilling priorities and focus throughout the pilot period. These insights underscore a requirement for tailoring upskilling elements and education initiatives to sites’ specific circumstances and changing maturity during development. Subsequently an upskilling framework, informed by these program learnings, was established to guide future workforce development and growth needs.</div></div><div><h3>Conclusion</h3><div>Although limited by a small sample size, this pilot program has demonstrated the potential of a tailored multi-modal upskilling approach to provide valuable professional learning experiences in clinical trial coordination, and support clinical trial site capability development. Clinical trial sites adoption of upskilling programs requires harmonisation and structured support through adaptive implementation, as described by the CTC upskilling framework. Upskilling CTCs in parallel with increasing clinical trial site capability is required if sites are to be adequately mature, and be able to meet the growing demands of Australian communities.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101460"},"PeriodicalIF":1.4,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143474770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Intervention delivery complexity and adaptations for implementation of non-pharmacologic pain interventions

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-15 DOI: 10.1016/j.conctc.2025.101453

Lindsay A. Ballengee , Maggie E. Horn , Trevor A. Lentz , Devon Check , Leah L. Zullig , Steven Z. George

Background

Delivering evidence-based interventions remains challenging, particularly for complex conditions like chronic musculoskeletal pain. Non-pharmacologic treatments are recommended for many pain conditions, but implementing these can be difficult due to their complexity and resource demands. Pragmatic trials, especially embedded designs, provide a method to see how interventions are being implemented and adapted in real-world settings throughout the trial process. This study explored how intervention delivery complexity and adaptations differ between non-pharmacologic pain trials and non-pain trials to provide guidance on future treatment delivery and implementation.

Methods

From July to October 2023, an online survey was distributed to members of three NIH Trial Collaboratories to assess intervention delivery complexity and adaptations during their pragmatic trials. Participants rated their trial's intervention delivery complexity using a 7-item tool and reported any adaptations to intervention delivery throughout the trial process. Data analysis compared complexity and adaptations between the two trial types to explore differences and relationships between intervention delivery complexity and adaptations.

Results

We analyzed 12 pain and 12 non-pain trials and found that intervention delivery complexity was not discernibly different between the two trial types, however, pain trials did have a slightly higher average intervention delivery complexity, overall. Pain trials also had more adaptations in the workflow domain compared to non-pain trials, while adaptations across other domains were similar between the two types. Workflow emerged as the most challenging domain for adaptation among all trials.

Conclusion

Intervention delivery complexity may be higher for pragmatic trials that are investigating non-pharmacologic pain interventions versus non-pain trials, but only in very specific areas.

{"title":"Intervention delivery complexity and adaptations for implementation of non-pharmacologic pain interventions","authors":"Lindsay A. Ballengee , Maggie E. Horn , Trevor A. Lentz , Devon Check , Leah L. Zullig , Steven Z. George","doi":"10.1016/j.conctc.2025.101453","DOIUrl":"10.1016/j.conctc.2025.101453","url":null,"abstract":"<div><h3>Background</h3><div>Delivering evidence-based interventions remains challenging, particularly for complex conditions like chronic musculoskeletal pain. Non-pharmacologic treatments are recommended for many pain conditions, but implementing these can be difficult due to their complexity and resource demands. Pragmatic trials, especially embedded designs, provide a method to see how interventions are being implemented and adapted in real-world settings throughout the trial process. This study explored how intervention delivery complexity and adaptations differ between non-pharmacologic pain trials and non-pain trials to provide guidance on future treatment delivery and implementation.</div></div><div><h3>Methods</h3><div>From July to October 2023, an online survey was distributed to members of three NIH Trial Collaboratories to assess intervention delivery complexity and adaptations during their pragmatic trials. Participants rated their trial's intervention delivery complexity using a 7-item tool and reported any adaptations to intervention delivery throughout the trial process. Data analysis compared complexity and adaptations between the two trial types to explore differences and relationships between intervention delivery complexity and adaptations.</div></div><div><h3>Results</h3><div>We analyzed 12 pain and 12 non-pain trials and found that intervention delivery complexity was not discernibly different between the two trial types, however, pain trials did have a slightly higher average intervention delivery complexity, overall. Pain trials also had more adaptations in the workflow domain compared to non-pain trials, while adaptations across other domains were similar between the two types. Workflow emerged as the most challenging domain for adaptation among all trials.</div></div><div><h3>Conclusion</h3><div>Intervention delivery complexity may be higher for pragmatic trials that are investigating non-pharmacologic pain interventions versus non-pain trials, but only in very specific areas.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101453"},"PeriodicalIF":1.4,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143465005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-15 DOI: 10.1016/j.conctc.2025.101462

Florent Dubois , Emilie Champiot-Bayard , Bogdan Cireașă , Paul Loubet , Jérôme Vallat , Julie Bonnet , Valérie Jacob , Pauline Puyo , Ioana Pînzar , Sarah Théret , Emmanuelle Dubois , Elisabeth Peus , Laurent Giraudon , Clarisse Roux-Marson , Pascale Fabbro-Peray , Géraldine Leguelinel-Blache , Jean-Marie Kinowski

Background

Streptococcus pneumoniae causes infections especially in patients with immunodeficiency or specific comorbidities. Most could be avoided through pneumococcal vaccination (PV), but PV coverage is only 20 % in France. Many studies assess methods on vaccination coverage improvement, but none evaluates pharmacist-physician collaboration in hospital on PV coverage of inpatients at-risk of invasive pneumococcal disease (IPD).

Methods

This study is a multicentric stepped-wedged randomized trial involving 12 units in 9 French hospitals (3 university and 6 local) during 4 periods of 90 days each. Three clusters will be made, each composed randomly of clinical and surgical units from one university hospital and clinical and surgical units of 2 local hospitals. For each period, one unit will have to include 16 non-vaccinated inpatients at risk of IPD. Patients in the control phase will receive usual care. During the interventional phase, the pharmacist will inform the physician on PV necessity, who will report recommendation and prescribe it at discharge. The pharmacist will perform a consultation and send a discharge letter to the patient's community pharmacist. The primary outcome will assess the impact of intervention on PV coverage after 6 months. Secondary outcomes will evaluate vaccines dispensing, uncompleted protocol rate and intervention process. A subgroup analysis between university and local hospitals and clinical and surgical units, respectively will be made.

Discussion

This study will assess the impact of medico-pharmaceutical collaboration in hospital on PV coverage in inpatients at risk of IPD. Hospitalization could be a way to promote vaccination and enhance healthcare system performance.

Trial registration

Clinicaltrials.gov, NCT05060146. Registered on September 16th, 2021.

{"title":"Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study","authors":"Florent Dubois , Emilie Champiot-Bayard , Bogdan Cireașă , Paul Loubet , Jérôme Vallat , Julie Bonnet , Valérie Jacob , Pauline Puyo , Ioana Pînzar , Sarah Théret , Emmanuelle Dubois , Elisabeth Peus , Laurent Giraudon , Clarisse Roux-Marson , Pascale Fabbro-Peray , Géraldine Leguelinel-Blache , Jean-Marie Kinowski","doi":"10.1016/j.conctc.2025.101462","DOIUrl":"10.1016/j.conctc.2025.101462","url":null,"abstract":"<div><h3>Background</h3><div><em>Streptococcus pneumoniae</em> causes infections especially in patients with immunodeficiency or specific comorbidities. Most could be avoided through pneumococcal vaccination (PV), but PV coverage is only 20 % in France. Many studies assess methods on vaccination coverage improvement, but none evaluates pharmacist-physician collaboration in hospital on PV coverage of inpatients at-risk of invasive pneumococcal disease (IPD).</div></div><div><h3>Methods</h3><div>This study is a multicentric stepped-wedged randomized trial involving 12 units in 9 French hospitals (3 university and 6 local) during 4 periods of 90 days each. Three clusters will be made, each composed randomly of clinical and surgical units from one university hospital and clinical and surgical units of 2 local hospitals. For each period, one unit will have to include 16 non-vaccinated inpatients at risk of IPD. Patients in the control phase will receive usual care. During the interventional phase, the pharmacist will inform the physician on PV necessity, who will report recommendation and prescribe it at discharge. The pharmacist will perform a consultation and send a discharge letter to the patient's community pharmacist. The primary outcome will assess the impact of intervention on PV coverage after 6 months. Secondary outcomes will evaluate vaccines dispensing, uncompleted protocol rate and intervention process. A subgroup analysis between university and local hospitals and clinical and surgical units, respectively will be made.</div></div><div><h3>Discussion</h3><div>This study will assess the impact of medico-pharmaceutical collaboration in hospital on PV coverage in inpatients at risk of IPD. Hospitalization could be a way to promote vaccination and enhance healthcare system performance.</div></div><div><h3>Trial registration</h3><div>Clinicaltrials.gov, NCT05060146. Registered on September 16th, 2021.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101462"},"PeriodicalIF":1.4,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143454532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Cardio-metabolic health and sleep quality in adults at risk for Type 2 Diabetes using the Fos Biomedical Non-Transdermal Patch System via photo-biomodulation: A randomized, placebo-controlled crossover trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-15 DOI: 10.1016/j.conctc.2025.101448

Valentine Y. Njike , Rockiy G. Ayettey , Judith A. Treu , Beth Patton Comerford , Maureen Onuigbo

Background

The impact of the Fos Biomedical non-transdermal patch system (NTPS) that stimulates the skin with low light levels to generate photo-biomodulation (PBM) effects on cardio-metabolic health and sleep quality is unclear. We examined the impact of FBPS compared with placebo on cardio-metabolic risk and sleep quality in persons at risk for type 2 diabetes mellitus (T2DM).

Methods

The study was a randomized, controlled, double-blind, crossover trial of 39 adults (mean age 64.4 years; 28 women, 11 men; 38 Caucasians, 1 African American) at risk for T2DM assigned to one of two possible sequence permutations of two treatments (Fos Biomedical NTPS and placebo), with an 8-week washout period. Fos Biomedical NTPSs are designed to stimulate the skin with low light levels to produce PBM effects. Participants were instructed to apply the active or placebo patches above and below the belly button for 12 h each day for 12 weeks. Primary outcome measure was glycated hemoglobin (HbA1c). Secondary outcome measures included insulin sensitivity, lipid profile, blood pressure, body composition, C-reactive protein, endothelial function, and sleep quality.

Results

Compared with the placebo, the Fos Biomedical NTPS did not improve glycemic control: HbA1c (0.1 ± 0.2 % vs. 0.1 ± 0.2 %; p = 0.5154). Compared with placebo, Fos Biomedical NTPS reduced endothelial function (−1.7 ± 12.1 % vs. 3.9 ± 10.0 %; p = 0.0344) while other markers of cardiovascular risk (i.e., body composition, blood pressure, lipid profile, and inflammatory biomarker) and sleep quality were unaffected (p > 0.05).

Conclusions

Photo-biomodulation generated from Fos Biomedical NTPS did not improve biomarkers of cardio-metabolic risk and sleep quality among those at risk for T2DM.

Clinical trial registration number

NCT05628597.

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引用次数: 0

Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-12 DOI: 10.1016/j.conctc.2025.101457

Carrington CJ. Shepherd , Melissa A. Dunham , Lina Gubhaju , Karen E. Lamb , Digsu N. Koye , Phoebe Fitzpatrick , Emily Banks , Kaarin J. Anstey , Melinda Carrington , Daniel McAullay , Ofra Kalter-Leibovici , Grace Joshy , Lesley Nelson , Jason Agostino , Ellie Paige , Kathleen Abu-Saad , Elise Alexander , Rona MacNiven , Kelsey Griffen , Fiona Collins , Sandra Eades

Background

Limited available data indicate that dementia prevalence rates among Aboriginal and Torres Strait Islander (hereafter Aboriginal) peoples are 3–5 times higher than the overall Australian population. Effective, pragmatic and scalable interventions are urgently required to address this disproportionate burden of dementia in Aboriginal populations.

Methods

Kaat Koort is a pragmatic two-arm parallel-group randomized controlled trial which will recruit a sample of 354 participants from two Aboriginal community-controlled health services in the south-west of Western Australia. Eligible participants are aged 35–60 years with risk factors for cardiovascular disease. Participants will be randomized in a 1:1 ratio to receive either a 12-month multifactorial lifestyle intervention (guided by Aboriginal Health Practitioners) that involves cardiovascular risk management, a lifestyle program targeting diet and physical activity, and support for smoking cessation and depression, or usual care (control). The primary endpoints are change in (i) systolic, and (ii) diastolic blood pressure. Secondary endpoints are changes in other cardiovascular risk factors (elevated blood pressure, HDL cholesterol, HbA1c, waist circumference, and absolute cardiovascular risk score), cognitive functioning, and adherence to Australian dietary and physical activity guidelines. Outcomes will be collected at baseline, and 6- and 12-months post-baseline.

Discussion

This trial aims to determine the efficacy of a multifactorial lifestyle intervention in reducing blood pressure among Aboriginal people aged 35–60 years at risk of dementia.

Trial registration number

ACTRN12621001022853; Australian New Zealand Clinical Trial Registry identifier.

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引用次数: 0

Effects and safety of acupuncture versus non-penetrating sham acupuncture for senile pruritus: Rationale and design for a randomized controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-12 DOI: 10.1016/j.conctc.2025.101454

He Chen , Sixing Liu , Shuai Gao , Jiamin Yi , Hangyu Shi , Jiufei Fang , Weiming Wang , Huan Chen , Zhishun Liu

Background

Senile pruritus (SP), characterized by idiopathic itch in individuals aged 60 years and older without primary skin lesions, significantly impacts sleep and quality of life. Effective alternative treatments are needed. Acupuncture has been suggested as a potential intervention to alleviate pruritus; however, its role in managing SP remains uncertain. This study aims to evaluate the efficacy and safety of acupuncture for SP.

Methods

This single-center, parallel, two-arm, randomized, sham-controlled trial will enroll 200 patients diagnosed with SP in a 1:1 ratio to either the acupuncture or sham acupuncture group, receiving acupuncture or sham acupuncture three sessions weekly for six weeks. Participants, outcome assessors, and the statisticians will be blinded. The primary outcome is the change from baseline in the Average Pruritus Numerical Rating Scale (AP-NRS) score at week 6. Secondary outcomes include changes in AP-NRS (at other timepoints), Peak Pruritus Numerical Rating Scale (PP-NRS), number of scratch episodes, itchy area of body surface, overall dry skin score (ODS), the Dermatology Life Quality Index (DLQI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and Patient Global Impression of Change (PGIC). Long-term effects of acupuncture will also be explored. Adverse events and additional treatments will be monitored throughout the study period. The modified intention-to-treat (mITT) population which includes participants who complete baseline assessments and receive at least one treatment session will be analyzed.

Discussion

This trial represents the first rigorously designed, single-center, randomized, sham-controlled study assessing the effects and safety of acupuncture for senile pruritus. We used valid outcome measurements which can provide valuable insights into the patient's symptoms and facilitate tracking symptoms over time and evaluate treatment effectiveness. This study may provide valuable insights into the research topic and inform future research.

Ethics and dissemination

This study has received ethical approval from the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (2024-087-KY).

Trial registration

Registered with ClinicalTrials.gov (NCT06506240) on July 11, 2024.

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引用次数: 0