journal
https://read.qxmd.com/read/38532503/the-repair-study-oral-antibiotics-to-prevent-infection-and-wound-dehiscence-after-obstetric-perineal-tear-a-double-blinded-placebo-controlled-randomized-trial
#1
JOURNAL ARTICLE
Kathrine Perslev, Niels Klarskov, Thomas Bergholt, Hanna Jangö
BACKGROUND: Approximately 85% of women experience an obstetric tear at delivery and up to 25% subsequently experience wound dehiscence and/or infection. Previous publications suggest that intravenous antibiotics administrated during delivery reduces this risk. We do not know if oral antibiotics given after delivery can reduce the risk of wound dehiscence or infection. Our aim is to investigate whether three doses of oral antibiotics (amoxicillin 500 mg/clavulanic acid 125 mg) given after delivery can reduce the risk of wound dehiscence and infection in patients with a second-degree obstetric tear or episiotomy...
March 27, 2024: Trials
https://read.qxmd.com/read/38532422/cost-effectiveness-and-cost-utility-of-the-ball-and-socket-trapeziometacarpal-prosthesis-compared-to-trapeziectomy-and-ligament-reconstruction-study-protocol-for-a-randomized-controlled-clinical-trial
#2
JOURNAL ARTICLE
Serafín Lirola-Palmero, Guillem Salva-Coll, Aina María Yáñez-Juan, Eduardo Sánchez-Iriso
BACKGROUND: Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The treatment is associated with costs and the recovery may take up to 1 year after surgery depending on the procedure. No randomized controlled trials have been conducted comparing ball and socket TMC prosthesis to trapeziectomy with ligament reconstruction. METHODS: A randomized, blinded, parallel-group superiority clinical trial comparing trapeziectomy with abductor pollicis longus (APL) arthroplasty and prosthetic replacement with Maïa® prosthesis...
March 27, 2024: Trials
https://read.qxmd.com/read/38532488/clinical-statistical-analysis-plan-for-the-accure-trial-the-effect-of-appendectomy-on-the-clinical-course-of-ulcerative-colitis-a-randomised-international-multicentre-trial
#3
RANDOMIZED CONTROLLED TRIAL
Eva Visser, Lianne Heuthorst, Shri Pathmakanthan, Willem A Bemelman, Geert R D'Haens, Kelly Handley, Apostolos Fakis, Thomas D Pinkney, Christianne J Buskens, Marcel G W Dijkgraaf
BACKGROUND: The primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the clinical course of UC, decreasing the incidence of relapses and reducing need for medication. The objective of the ACCURE trial is to assess the efficacy of laparoscopic appendectomy in addition to standard medical treatment in maintaining remission in UC patients. This article presents the statistical analysis plan to evaluate the outcomes of the ACCURE trial...
March 26, 2024: Trials
https://read.qxmd.com/read/38532475/pneumococcal-conjugate-vaccination-schedules-in-infants-acquisition-immunogenicity-and-pneumococcal-conjugate-and-yellow-fever-vaccine-co-administration-study-statistical-analysis-plan
#4
JOURNAL ARTICLE
Grant A Mackenzie, Isaac Osei, Rasheed Salaudeen, Paul V Licciardi, Brian Greenwood, Kim Mulholland, Cattram Nguyen
RATIONALE: The effectiveness of immunisation with pneumococcal conjugate vaccine (PCV) has been demonstrated in many countries. However, the global impact of PCV is limited by its cost, which has prevented its introduction in some countries. Reducing the cost of PCV programmes will facilitate further vaccine introductions and improve the sustainability of PCV in low-income countries when they transition from subsidised vaccine supply. We are conducting a large, population-level, cluster-randomised field trial (PVS) of an alternative reduced-dose schedule of PCV compared to the standard schedule...
March 26, 2024: Trials
https://read.qxmd.com/read/38532434/optimization-of-cardiopulmonary-bypass-prime-fluid-to-preserve-microcirculatory-perfusion-during-on-pump-coronary-artery-bypass-graft-surgery-prime-study-protocol-for-a-double-blind-randomized-trial
#5
JOURNAL ARTICLE
Anne M Beukers, Carolien S E Bulte, Ruben J Bosch, Susanne Eberl, Charissa E van den Brom, Stephan A Loer, Alexander B A Vonk
BACKGROUND: Acute microcirculatory perfusion disturbances and organ edema are important factors leading to organ dysfunction during cardiac surgery with cardiopulmonary bypass (CPB). Priming of the CPB system with crystalloid or colloid fluids, which inevitably leads to hemodilution, could contribute to this effect. However, there is yet no optimal evidence-based strategy for this type of priming. Hence, we will investigate different priming strategies to reduce hemodilution and preserve microcirculatory perfusion...
March 26, 2024: Trials
https://read.qxmd.com/read/38532432/implementing-and-evaluating-group-interpersonal-therapy-for-postnatal-depression-in-lebanon-and-kenya-individually-randomised-superiority-trial
#6
JOURNAL ARTICLE
Peter Fonagy, Rabih El Chammay, Carol Ngunu, Manasi Kumar, Lena Verdeli, Elizabeth Allison, Ghida Anani, Pasco Fearon, Fouad Fouad, Zoe Hoare, Lucina Koyio, Henrietta Moore, Andrew Nyandigisi, Stephen Pilling, Hannah Sender, Jolene Skordis, Rachel Evans, Gerard Joseph Abou Jaoude, Beatrice Madeghe, Sandra Pardi Arsen Maradian, Ciara O'Donnell, Elizabeth Simes, Alexandra Truscott, Grace Nduku Wambua, Obadia Yator
BACKGROUND: Depression ranks as the foremost mental health concern among childbearing women. Within low- and middle-income countries (LMICs), between 20 and 25% of women encounter depression during pregnancy or soon after delivery. This condition impacts not only the mothers but also their offspring. Offspring of women suffering from postnatal depression (PND) exhibit suboptimal cognitive development and increased emotional and behavioural issues throughout their growth. This scenario becomes more pronounced in LMICs, where numerous adversities further jeopardise children's developmental progress...
March 26, 2024: Trials
https://read.qxmd.com/read/38528619/the-aria-trial-protocol-a-randomised-controlled-trial-to-assess-the-clinical-technical-and-cost-effectiveness-of-a-cloud-based-artificially-intelligent-image-fusion-system-in-comparison-to-standard-treatment-to-guide-endovascular-aortic-aneurysm-repair
#7
JOURNAL ARTICLE
James Budge, Tom Carrell, Medeah Yaqub, Hatem Wafa, Matt Waltham, Izabela Pilecka, Joanna Kelly, Caroline Murphy, Stephen Palmer, Yanzhong Wang, Rachel E Clough
BACKGROUND: Endovascular repair of aortic aneurysmal disease is established due to perceived advantages in patient survival, reduced postoperative complications, and shorter hospital lengths of stay. High spatial and contrast resolution 3D CT angiography images are used to plan the procedures and inform device selection and manufacture, but in standard care, the surgery is performed using image-guidance from 2D X-ray fluoroscopy with injection of nephrotoxic contrast material to visualise the blood vessels...
March 25, 2024: Trials
https://read.qxmd.com/read/38528558/navigating-uncharted-territory-with-a-borrowed-map-lessons-from-setting-up-the-bath-out-2-randomised-controlled-trial-in-adult-social-care-and-housing-services-in-english-local-authorities
#8
LETTER
Jennifer McAnuff, Tim Rapley, Leigh Rooney, Phillip Whitehead
Populations around the world are rapidly ageing and more people are living with multiple long-term conditions. There is an urgent need for evidence about high quality, cost-effective, and integrated systems of health and social care. Health research funders are now also prioritising research in adult social care and wider local authority settings, e.g. housing services.Developing the evidence base for adult social care should include implementing randomised controlled trials, where appropriate. Within the UK, the clinical trial is the established road map for evaluating interventions in the National Health Service (NHS)...
March 25, 2024: Trials
https://read.qxmd.com/read/38520030/peers-plus-mobile-app-for-treatment-in-hiv-path-protocol-for-a-randomized-controlled-trial-to-test-a-community-based-integrated-peer-support-and-mhealth-intervention-to-improve-viral-suppression-among-hispanic-and-black-people-living-with-hiv
#9
JOURNAL ARTICLE
Eileen V Pitpitan, Keith J Horvath, Jeannette Aldous, Jamila K Stockman, Thomas L Patterson, Megan Liang, Constantino Barrozo, Veronica Moore, Katherine Penninga, Laramie R Smith
BACKGROUND: Significant disparities continue to exist in the HIV care continuum, whereby Hispanic and Black people living with HIV (PLWH) are less likely to achieve viral suppression compared to their White counterparts. Studies have shown that intervention approaches that involve peer navigation may play an important role in supporting patients to stay engaged in HIV care. However, implementation may be challenging in real-world settings where there are limited resources to support peer navigators...
March 22, 2024: Trials
https://read.qxmd.com/read/38519988/tocilizumab-in-chronic-active-antibody-mediated-rejection-rationale-and-protocol-of-an-in-progress-randomized-controlled-open-label-multi-center-trial-intercept-study
#10
JOURNAL ARTICLE
Lillian Streichart, Marie Felldin, Jana Ekberg, Lars Mjörnstedt, Per Lindnér, Annette Lennerling, Verena Bröcker, Johan Mölne, Jan Holgersson, Kristien Daenen, Lars Wennberg, Tomas Lorant, Seema Baid-Agrawal
BACKGROUND: Chronic active antibody-mediated rejection (caAMR) in kidney transplants is associated with irreversible tissue damage and a leading cause of graft loss in the long-term. However, the treatment for caAMR remains a challenge to date. Recently, tocilizumab, a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor, has shown promise in the treatment of caAMR. However, it has not been systematically investigated so far underscoring the need for randomized controlled studies in this area...
March 22, 2024: Trials
https://read.qxmd.com/read/38519961/the-effects-of-phoniatric-prehabilitation-in-head-and-neck-cancer-patients-on-aspiration-and-preservation-of-swallowing-prehaps-study-protocol-of-a-monocentric-prospective-randomized-interventional-outcome-blinded-trial
#11
JOURNAL ARTICLE
Julian Kuenzel, Stephan Duerr, Sarah Vester, Florian Zeman, Gunnar Huppertz, Michael Koller, Gerda Pfleger, Annika Woertgen, Hazem Salloum, Monika Klinkhammer-Schalke, Tobias Pukrop, Peter Kummer
BACKGROUND: Dysphagia, with its negative impact on life expectancy and quality of life, is a major side effect of head and neck squamous cell carcinoma (HNSCC). In a typical Head and Neck Cancer Center, more than half of patients are affected. Improving treatment, and ideally prevention respectively prehabilitation, therefore seems more than desirable. METHODS: The study is planned as a monocentric, prospective, outcome-blinded, randomized interventional study comparing an advanced phoniatric-logopedic prehabilitation with a control (standard of care)...
March 22, 2024: Trials
https://read.qxmd.com/read/38515207/the-effect-of-selenium-supplementation-on-oxidative-stress-clinical-symptoms-and-mental-health-status-in-patients-with-migraine-a-study-protocol-for-a-double-blinded-randomized-clinical-trial
#12
JOURNAL ARTICLE
Arghavan Balali, Omid Sadeghi, Javad Anjom-Shoae, Mohammad Hossein Rouhani, Fariborz Khorvash, Gholamreza Askari
BACKGROUND: Despite a number of recommended strategies, effective treatment of migraine remains elusive. Given the role of oxidative stress in the pathogenesis of migraine, selenium, as an antioxidant nutrient, may have a beneficial effect on migraine outcomes. However, no study has explored the effects of selenium supplementation on migraine symptoms, oxidative stress biomarkers, and mental health. Therefore, this randomized, double-blinded, placebo-controlled clinical trial aims to examine the effects of selenium supplementation among migraine patients...
March 22, 2024: Trials
https://read.qxmd.com/read/38515199/sacral-neuromodulation-for-constipation-and-fecal-incontinence-in-children-and-adolescents-study-protocol-of-a-prospective-randomized-trial-on-the-application-of-invasive-vs-non-invasive-technique
#13
JOURNAL ARTICLE
Manuel Besendörfer, Annemarie Kirchgatter, Roman Carbon, Christel Weiss, Hanna Müller, Klaus E Matzel, Sonja Diez
BACKGROUND: A therapeutic effect of sacral neuromodulation (SNM) on fecal incontinence (FI) and quality of life has been proven in adults. SNM is, however, rarely used in pediatric cases. The aim of the study is to investigate effects of SNM in pediatric constipation in a prospective parallel-group trial. METHODS: A monocentric, randomized, unblinded, parallel-group trial is conducted. SNM is conducted in the invasive variant and in an innovative, external approach with adhesive electrodes (enteral neuromodulation, ENM)...
March 22, 2024: Trials
https://read.qxmd.com/read/38515201/interactive-virtual-assistance-for-mental-health-promotion-and-self-care-management-in-elderly-with-type-2-diabetes-ivam-ed-study-protocol-and-statistical-analysis-plan-for-a-randomized-controlled-trial
#14
JOURNAL ARTICLE
Frederico Ludwig da Costa, Lucas Strassburger Matzenbacher, Vicenzo Gheno, Maria Antônia Bertuzzo Brum, Laura Gomes Boabaid de Barros, Isabela Semmelmann Maia, Luiza Machado Blank, Lucas Friedrich Fontoura, Janine Alessi, Gabriela Heiden Telo
BACKGROUND: With one in five individuals aged 65 or older living with type 2 diabetes worldwide, it is crucial to acknowledge and address the challenges faced by this population. In this context, our study aims to evaluate the efficacy of a behavioral intervention model delivered through a smart speaker on mental health and diabetes self-care in the elderly with diabetes. METHODS: This is a single-center, pragmatic, parallel two-arm open randomized clinical trial involving elderly patients with type 2 diabetes...
March 21, 2024: Trials
https://read.qxmd.com/read/38515150/evaluation-of-a-disability-inclusive-ultra-poor-graduation-programme-in-uganda-study-protocol-for-a-cluster-randomised-controlled-trial-with-process-evaluation
#15
JOURNAL ARTICLE
Elijah Kipchumba, Calum Davey, Sarah Marks, Anthony Mugeere, Shanquan Chen, Lena Morgon Banks, Kazi Eliza Islam, Tom Shakespeare, Hannah Kuper, Munshi Sulaiman
BACKGROUND: There is little evidence on how to support ultra-poor people with disabilities to adopt sustainable livelihoods. The Disability-Inclusive Graduation (DIG) programme targets ultra-poor people with disabilities and/or women living in rural Uganda. The programme is an adaptation of an ultra-poor graduation model that has been shown to be effective in many contexts but not evaluated for people with disabilities. METHODS: The DIG programme works with project participants over a period of 18 months...
March 21, 2024: Trials
https://read.qxmd.com/read/38515146/effect-of-an-entry-to-care-intervention-on-diabetes-distress-in-individuals-with-newly-diagnosed-type-2-diabetes-a-study-protocol-for-a-cluster-randomized-trial
#16
JOURNAL ARTICLE
Steffan Holst Hansen, Troels Mygind Jensen, Gitte Stentebjerg Petersen, Francois Pouwer, Anders L Sønderlund, Jens Søndergaard
BACKGROUND: Diabetes distress (DD) affects at least 36% of T2DM patients and is often associated with insufficient support and care. This study examines an intervention that targets DD through enhanced cross-sectoral collaboration and treatment during the first 3 months following diagnosis. The intervention aims to improve care and self-management and to reduce DD. METHODS AND INTERVENTION: The study is designed as a cluster-randomized trial with the intervention focusing on four key elements of diabetes care: effective cross-sectoral communication and information sharing, systematic care, a "one-stop-shop" health screening and start-up conversation at the municipality, and improving patient insights into own care...
March 21, 2024: Trials
https://read.qxmd.com/read/38515145/correction-effectiveness-and-cost-effectiveness-of-a-transdiagnostic-intervention-for-alcohol-misuse-and-psychological-distress-in-humanitarian-settings-study-protocol-for-a-randomised-controlled-trial-in-uganda
#17
Catharina F van der Boor, Dalili Taban, Wietse A Tol, Josephine Akellot, Melissa Neuman, Helen A Weiss, Giulia Greco, Anna Vassall, Carl May, Abhijit Nadkarni, Eugene Kinyanda, Bayard Roberts, Daniela C Fuhr
No abstract text is available yet for this article.
March 21, 2024: Trials
https://read.qxmd.com/read/38515103/developing-generic-templates-to-shape-the-future-for-conducting-integrated-research-platform-trials
#18
JOURNAL ARTICLE
Madhavi Gidh-Jain, Tom Parke, Franz König, Cecile Spiertz, Peter Mesenbrink
BACKGROUND: Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Practice-scientific guideline, first published in 2002 and last updated in 2016. This document provides an international ethical and scientific quality standard for designing and conducting trials that involve the participation of human subjects. Recently, there has been heightened awareness of the importance of integrated research platform trials (IRPs) designed to evaluate multiple therapies simultaneously...
March 21, 2024: Trials
https://read.qxmd.com/read/38509517/investigating-the-use-of-finerenone-in-children-with-chronic-kidney-disease-and-proteinuria-design-of-the-fiona-and-open-label-extension-studies
#19
RANDOMIZED CONTROLLED TRIAL
Franz Schaefer, Giovanni Montini, Hee Gyung Kang, Johan Vande Walle, Joshua Zaritsky, Michiel F Schreuder, Mieczyslaw Litwin, Andrea Scalise, Helen Scott, James Potts, Pablo Iveli, Stefanie Breitenstein, Bradley A Warady
INTRODUCTION: Proteinuria is a modifiable risk factor for chronic kidney disease (CKD) progression in children. Finerenone, a selective, non-steroidal, mineralocorticoid receptor antagonist (MRA) has been approved to treat adults with CKD associated with type 2 diabetes mellitus (T2DM) following results from the phase III clinical trials FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049). In a pre-specified pooled analysis of both studies (N = 13,026), finerenone was shown to have an acceptable safety profile and was efficacious in decreasing the risk of adverse kidney and cardiovascular outcomes and of proteinuria...
March 21, 2024: Trials
https://read.qxmd.com/read/38509614/multicentre-randomised-controlled-trial-of-physiological-based-cord-clamping-versus-immediate-cord-clamping-in-infants-with-a-congenital-diaphragmatic-hernia-pinc-statistical-analysis-plan
#20
RANDOMIZED CONTROLLED TRIAL
Emily J J Horn-Oudshoorn, Marijn J Vermeulen, Ronny Knol, Rebekka Bout-Rebel, Arjan B Te Pas, Stuart B Hooper, Suzan C M Cochius-den Otter, Rene M H Wijnen, Kelly J Crossley, Neysan Rafat, Thomas Schaible, Willem P de Boode, Anne Debeer, Berndt Urlesberger, Calum T Roberts, Florian Kipfmueller, Irma Capolupo, Carmen M Burgos, Bettina E Hansen, Irwin K M Reiss, Philip L J DeKoninck
BACKGROUND: Infants born with congenital diaphragmatic hernia (CDH) are at high risk of respiratory insufficiency and pulmonary hypertension. Routine practice includes immediate clamping of the umbilical cord and endotracheal intubation. Experimental animal studies suggest that clamping the umbilical cord guided by physiological changes and after the lungs have been aerated, named physiological-based cord clamping (PBCC), could enhance the fetal-to-neonatal transition in CDH. We describe the statistical analysis plan for the clinical trial evaluating the effects of PBCC versus immediate cord clamping on pulmonary hypertension in infants with CDH (PinC trial)...
March 20, 2024: Trials
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