Contemporary Clinical Trials Communications最新文献

{"title":"Sevoflurane multiple Wash In/Wash Out at the end of anesthesia to reduce agitation: A multicenter double-blind randomized controlled trial","authors":"Giovanni Landoni ,&nbsp;Valery V. Likhvantsev ,&nbsp;Levan B. Berikashvili ,&nbsp;Andrey G. Yavorovsky ,&nbsp;Pavel S. Bagdasarov ,&nbsp;Anastasia V. Smirnova ,&nbsp;Tatiana S. Serkova ,&nbsp;Valery V. Subbotin ,&nbsp;Kristina K. Kadantseva ,&nbsp;Alexey M. Ovezov ,&nbsp;Mikhail Ya Yadgarov ,&nbsp;Alexey A. Yakovlev ,&nbsp;Andrea Lamacchia ,&nbsp;Lorenzo Gallo ,&nbsp;Nadezhda D. Gracheva ,&nbsp;Pavel V. Ryzhkov ,&nbsp;Rachele Zilocchi ,&nbsp;Jessica De Vecchi ,&nbsp;Maksim A. Aleinikov ,&nbsp;Pavel S. Mayuk ,&nbsp;Maria M. Shemetova","doi":"10.1016/j.conctc.2024.101316","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101316","url":null,"abstract":"<div><h3>Background</h3><p>Postoperative agitation is common after non-cardiac surgery. It is associated with postoperative delirium and cognitive dysfunction, leading to prolonged hospital stay and delayed social readjustment. Prevention and treatment strategies are lacking. We assessed the efficacy of a novel approach, the Wash In/Wash Out procedure, in reducing post-anesthetic agitation.</p></div><div><h3>Methods</h3><p>This multicenter, parallel-group, double-blind randomized controlled trial is enrolling 200 patients undergoing open abdominal surgery. Participants are randomly assigned to either a control group receiving standard recovery methods or an investigational group undergoing the Wash In/Wash Out procedure. In the Wash In/Wash Out procedure group, sevoflurane is stopped and then promptly restarted when the patient shows the first signs of awakening to achieve an end-tidal concentration of 1 minimum alveolar concentration (MAC) for 5 min. This stop-and-restart cycle is performed three times. The trial's primary outcome is the rate of postoperative agitation. Secondary outcomes include rate of postoperative delirium and cognitive dysfunction, postoperative nausea and vomiting, and length of intensive care and hospital stay.</p></div><div><h3>Discussion</h3><p>The OPERA trial investigates the effect of the Wash In/Wash Out procedure to reduce post-anesthetic agitation in non-cardiac surgery. This study could offer a significant contribution to improving patient outcomes and optimizing recovery protocols in surgical settings.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000632/pdfft?md5=e6edf3c960e2f8f6c8502ee65605d40e&pid=1-s2.0-S2451865424000632-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141242614","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}

{"title":"The IRIS clinic: A Protocol for a mixed-methods study evaluating the management of Hyperemesis Gravidarum","authors":"Eileen C. O'Brien ,&nbsp;Jean Doherty ,&nbsp;Sarah Louise Killeen ,&nbsp;Melanie Bennett ,&nbsp;Lillian Murtagh ,&nbsp;Sinead Curran ,&nbsp;Suzanne Murphy ,&nbsp;Helen McHale ,&nbsp;Lucille Sheehy","doi":"10.1016/j.conctc.2023.101227","DOIUrl":"10.1016/j.conctc.2023.101227","url":null,"abstract":"<div><h3>Background</h3><p>Hyperemesis Gravidarum (HG) is a severe form of nausea and vomiting in pregnancy that affects 0.3–3% of women and has profound nutritional, physical and psychological consequences. Research is lacking regarding the most effective management of the condition. In response to patient feedback, a multidisciplinary HG day-case service (IRIS Clinic) was launched in 2020 at The National Maternity Hospital, Ireland. The clinic provides routine, day-case care in a comfortable space with pre-booked appointments. The MDT involves midwives, dietitians, perinatal mental health, obstetrics and pharmacy, and the nature of the clinic enables peer-to-peer support. As this clinic is the first of its kind in Ireland, we aim to assess its effectiveness and feasibility, and suggest recommendations for improvement.</p></div><div><h3>Methods</h3><p>This is a sequential, mixed-methods study that commenced in August 2021. The prospective arm of the study is ongoing and involves enrolling women (n = 50) who are attending the IRIS clinic. Data are collected on first admission (pre-intervention) and approximately 8 weeks' later (post-intervention) relating to symptoms of HG, well-being, food tolerances, quality of life and nutritional intake. Qualitative, semi-structured interviews will be conducted to evaluate women's experiences of attending the clinic. The retrospective arm of the study will be a chart review (n = 200) of women diagnosed with HG to describe assessments, treatments and pregnancy and birth outcomes.</p></div><div><h3>Conclusion</h3><p>The IRIS clinic has the potential to improve pregnancy outcomes and nutritional status among women with HG. If found to be effective and feasible, the model for this clinic could be replicated elsewhere.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865423001734/pdfft?md5=c01f5bf612dc3e7a6524833598a4e915&pid=1-s2.0-S2451865423001734-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135566920","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}

{"title":"A multidisciplinary approach on music induced-analgesia differentiated by socio-cultural background in healthy volunteers (MOSART): A cross-over randomized controlled trial protocol","authors":"Antonia S. Becker ,&nbsp;Emy S. van der Valk Bouman ,&nbsp;Julian Schaap ,&nbsp;Cecile C. de Vos ,&nbsp;Koen van Eijck ,&nbsp;Hans Jeekel ,&nbsp;Markus Klimek","doi":"10.1016/j.conctc.2024.101313","DOIUrl":"10.1016/j.conctc.2024.101313","url":null,"abstract":"<div><h3>Background</h3><p>Integrating music into pain treatment demonstrates significant benefits, effectively reducing subjective pain levels and perioperative opioid requirements. Currently, the relationship between the impact of specific types of music and listeners’ socio-cultural background is still unclear. This is especially relevant given that sociological research indicates that these factors can have a notable influence on music preference and perception. Current evidence suggests that individuals who choose their own music may experience greater benefits. However, additional research is needed to comprehensively grasp whether the effect of (preferred) music on pain endurance remains consistent across different socio-cultural backgrounds.</p></div><div><h3>Methods</h3><p>In this study, a collaborative effort between medical and sociological researchers aims to investigate music-induced analgesia differentiated by socio-cultural background in healthy volunteers. Participants (n = 84) will listen to self-, and researcher-chosen music and a podcast as a control condition in a cross-over study design. The primary outcome of this study is pain endurance measured by electric stimuli of increasing intensity. Detailed sociological validated questionnaires will be utilized. Considering the notable influence of educational level on music taste formation found in previous research and its crucial role as a source of socio-cultural differentiation, participants will be stratified based on their level of education.</p></div><div><h3>Discussion</h3><p>This experimental study represents one of the first efforts to gain a socio-culturally differentiated understanding of the therapeutic potential of music. Consequently, this could pave the way to purposefully and inclusively implement personalized music in healthcare settings.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000607/pdfft?md5=04cd782c585f91e29a4d57b4052689ba&pid=1-s2.0-S2451865424000607-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141139199","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}

{"title":"Corrigendum to “Design of a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of prucalopride in pediatric patients with functional constipation” [Contemp. Clin. Trials Commun. 33 (2023) 101144]","authors":"Carmen Cuffari ,&nbsp;William Spalding ,&nbsp;Heinrich Achenbach ,&nbsp;Manoj Thakur ,&nbsp;André Gabriel","doi":"10.1016/j.conctc.2024.101302","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101302","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000498/pdfft?md5=4137f10c22df2a6c934a8909a4b6104d&pid=1-s2.0-S2451865424000498-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141314156","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}

{"title":"Implementing regular physical activity for older individuals in the family strategy program using the RE-AIM framework to ensure feasibility and sustainability: EISI study protocol","authors":"Saulo Vasconcelos Rocha ,&nbsp;Clarice Alves dos Santos ,&nbsp;Ariani França Conceição ,&nbsp;Bruna Maria Palotino-Ferreira ,&nbsp;Danilo Barbosa Morais ,&nbsp;Félix Salvador Chavane ,&nbsp;Carolina Rego Chaves Dias ,&nbsp;André Luís Lacerda Bachi ,&nbsp;Rui Mendes ,&nbsp;Sónia Brito-Costa ,&nbsp;Sofia Silva ,&nbsp;Guilherme Eustáquio Furtado","doi":"10.1016/j.conctc.2024.101311","DOIUrl":"10.1016/j.conctc.2024.101311","url":null,"abstract":"<div><p>The EISI study protocol aims to address the low participation rate in physical exercise programs among older individuals, emphasizing its significance as a non-pharmacological therapeutic approach for overall health and increased physical activity. The objectives include implementing physical activity (PA) and educational health programs in Jequié, Bahia, Brazil, targeting the Family Health Strategy population to enhance local physical activity levels among older individuals. The study also seeks to evaluate the program's feasibility, safety, and sustainability for large-scale implementation, along with assessing its impact on immune and inflammatory response biomarkers to the SARS-CoV virus, as well as physical-functional and brain health. Participants, aged 60 or above, will be divided into two groups: multicomponent exercise (MCE) and behavioral change interventions (BCI). The study employs a mixed-method approach, utilizing a non-randomized controlled short-term pathway model for a 4–8 weeks of pilot study and 16-week intervention impact assessment. Data collection encompasses various aspects such as sociodemographic information, mental health, physical fitness, fall risk, functional capacity, anthropometric measurements, hemodynamic assessment, habitual physical activity, and health-related quality of life. Blood and saliva samples are collected for cytokine and antibody biomarker analysis related to SARS-CoV immunity. Pre- and post-intervention evaluations for both groups will be conducted, with the hypothesis that MCE will yield more favorable responses compared to BCI. The study's holistic approach, including the assessment of feasibility, safety, and sustainability, aims to contribute to achieving Sustainable Development Goals (SDG) 3 and SDG 9 b y promoting accessible and sustainable healthcare initiatives for older individuals. This research aligns with global efforts to enhance health and well-being, emphasizing the importance of regular exercise in the aging population.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000589/pdfft?md5=c660e05ba5e11776c7d74c38a8dd6795&pid=1-s2.0-S2451865424000589-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141142351","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}

{"title":"The mechanism of Sangdantongluo granule in treating post-stroke spasticity based on multimodal fMRI combined with TMS: Study protocol","authors":"Jie Tang ,&nbsp;Yao Xie ,&nbsp;Rui Fang ,&nbsp;Huizhong Tan ,&nbsp;Shanshan Zeng ,&nbsp;Zan Wen ,&nbsp;Xiongxing Sun ,&nbsp;Ting Yao ,&nbsp;Shiliang Wang ,&nbsp;Le Xie ,&nbsp;Dahua Wu","doi":"10.1016/j.conctc.2024.101317","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101317","url":null,"abstract":"<div><h3>Introduction</h3><p>Post-stroke spasticity (PSS) is among the prevalent complications of stroke, greatly affecting motor function recovery and reducing patients' quality of life without timely treatment. Sangdantongluo granule, a modern traditional Chinese patent medicine, has significant clinical efficacy in treating PSS. However, the mechanism of Sangdantongluo granule in treating PSS is still unknown. We designed this study to explore the mechanism of Sangdantongluo granule in treating PSS through multimodal functional magnetic resonance imaging (fMRI) combined with transcranial magnetic stimulation (TMS).</p></div><div><h3>Methods and analysis</h3><p>In a single-center, randomized, double-blind, parallel placebo-controlled study, 60 PSS patients will be recruited in China and randomly assigned to either the experimental or control groups at a ratio of 1:1. For eight weeks, Sangdantongluo granule or placebo will be utilized for intervention. The main outcome is the Modified Ashworth Scale (MAS), the secondary outcome includes the Fugl-Meyer Assessment Scale-upper Extremity (FMA-UE), National Institute of Health Stroke Scale (NIHSS), and Modified Rankin Scale (mRS), the mechanism measure is the changes in cortical excitability and multimodal fMRI at baseline and after eight weeks.</p></div><div><h3>Ethics and dissemination</h3><p>This study was approved by the Ethics Committee of the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine (approval number: [202364]).</p></div><div><h3>Clinical trial registration</h3><p>Chinese Clinical Trial Registry, identifier: ChiCTR2300074793. Registered on 16 August 2023.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000644/pdfft?md5=1e9e021fab917dfcc2f4fd055b1555a4&pid=1-s2.0-S2451865424000644-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141249726","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}

{"title":"Redefining feasibility in clinical trials: Collaborative approaches for improved site selection","authors":"Beau Bruneau ,&nbsp;Kristin Surdam ,&nbsp;Amy Bland ,&nbsp;Amy Krueger ,&nbsp;Andrew Wise ,&nbsp;Ani Cotarlan ,&nbsp;Asher Leviton ,&nbsp;Elena Jouravleva ,&nbsp;Grace Fitzgerald ,&nbsp;Heather N. Frost ,&nbsp;Honora F. Cutler ,&nbsp;Joshua Buddle ,&nbsp;Luis G. Diaz ,&nbsp;Michele Cohen ,&nbsp;Nancy A. Sacco ,&nbsp;Ryan Washington ,&nbsp;Susan Mauermann ,&nbsp;Victor Chen ,&nbsp;Andrea Bastek","doi":"10.1016/j.conctc.2024.101291","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101291","url":null,"abstract":"<div><h3>Background</h3><p>This Site Feasibility Task Force convened to assess the complex and burdensome process of site feasibility in clinical trials. The objective was to create mutual understanding of challenges and provide suggestions for improving collaboration among sponsors, contract research organizations (CROs), and sites.</p></div><div><h3>Methods</h3><p>The task force was composed of representatives from sponsors, CROs and sites (43 % Sites, 20 % Site Networks, 10 % Small/mid-size sponsors, 10 % Small/mid-size CROs, 10 % Large sponsors, 7 % Large CROs). The group collaborated to define the scope of the problem, identify challenges in the current process, and provide suggestions for improving the process.</p></div><div><h3>Results</h3><p>The group found there is a need for better differentiation between the three main stages of feasibility, and the four sub-phases of Site Feasibility. The discussion brought to light emerging trends like early initiation of Site Feasibility and premature engagement of sites by CROs. To fully explain these challenges, the group analyzed the current practices and documented their downstream impact on clinical trial execution for all stakeholders. A list of best practices emerged naturally from this analysis. These findings are aggregated into short and actionable best practice guides.</p></div><div><h3>Conclusion</h3><p>The task force suggests practical changes for the feasibility process and raises awareness of emerging trends and their associated risks. This awareness can begin to drive change in the site feasibility process, although industry-wide transformation will require new levels of collaboration, data standardization and automation tools. The potential benefits of evolving this process are significant and meaningful for more efficient and successful clinical trials.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000383/pdfft?md5=1a790ad586aa6b1ed7ed1bb2d0816420&pid=1-s2.0-S2451865424000383-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141607967","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}

{"title":"Group sequential design for time-to-event outcome with non-proportional hazards using the concept of relative time utilizing two different Weibull distributions","authors":"Milind A. Phadnis,&nbsp;Nadeesha Thewarapperuma,&nbsp;Matthew S. Mayo","doi":"10.1016/j.conctc.2024.101315","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101315","url":null,"abstract":"<div><p>A group sequential design allows investigators to sequentially monitor efficacy and safety as part of interim testing in phase III trials. Literature is well developed in the case of continuous and binary outcomes, however, in case of trials with a time-to-event outcome, popular methods of sample size calculation often assume proportional hazards. In situations where the proportional hazards assumption is inappropriate as indicated by historical data, these popular methods are very restrictive. In this paper, a novel simulation-based group sequential design is proposed for a two-arm randomized phase III clinical trial with a survival endpoint for the non-proportional hazards scenario. By assuming that the survival times for each treatment arm follow two different Weibull distributions, the proposed method utilizes the concept of Relative Time to calculate the efficacy and safety boundaries at selected interim testing points. The test statistic used to generate these boundaries is asymptotically normal, allowing p-value calculation at each boundary. Many design features specific to time-to-event data can be incorporated with ease. Additionally, the proposed method allows the flexibility of having the accelerated failure time model and the proportional hazards model as constrained special cases. Real life applications are discussed demonstrating the practicality of the proposed method.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000620/pdfft?md5=8516d54cdf93e8647fb83e3297f9f4b8&pid=1-s2.0-S2451865424000620-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141486765","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}

{"title":"MDMA-assisted brief cognitive behavioral conjoint therapy for PTSD: Study protocol for a pilot study","authors":"L.A. Morland ,&nbsp;D. Perivoliotis ,&nbsp;T.R. Wachsman ,&nbsp;A. Alam ,&nbsp;K. Knopp ,&nbsp;C. Khalifian ,&nbsp;D. Ramanathan ,&nbsp;B.E. Chargin ,&nbsp;A.W. Bismark ,&nbsp;S. Glynn ,&nbsp;C. Stauffer ,&nbsp;A.C. Wagner","doi":"10.1016/j.conctc.2024.101314","DOIUrl":"10.1016/j.conctc.2024.101314","url":null,"abstract":"<div><h3>Background</h3><p>Posttraumatic Stress Disorder (PTSD) impacts both individual and relational functioning. Veteran couples are at increased risk of relationship distress due to military stressors such as deployment, family reintegration, and traumatic stress. Although both Cognitive-Behavioral Conjoint Therapy (CBCT) and its brief version (bCBCT) consistently have large effects on reducing PTSD symptoms, these treatments have more variable effects on relational outcomes. Given the impact of relationship functioning on the overall health of veterans, improving the effect of PTSD treatments on relationship functioning is an essential area of research. One promising path is the role of MDMA (3,4-methylenedioxymethamphetamine)-assisted therapy in augmenting the relational impact of established therapeutic interventions such as bCBCT.</p></div><div><h3>Method/Design</h3><p>This is a single site, open-label study assessing the preliminary efficacy, safety, and acceptability of MDMA-assisted therapy in combination with bCBCT in 8 veterans with PTSD and their intimate partners (<em>N</em> = 16). Therapy teams trained in bCBCT and MDMA-assisted therapy will deliver bCBCT combined with two MDMA sessions and two couple emotion focused integration sessions. PTSD symptom severity and relationship functioning outcomes will be evaluated.</p></div><div><h3>Conclusion</h3><p>This is the first study to examine the efficacy of MDMA-assisted bCBCT for improving PTSD and relationship functioning among a sample of U.S. military veterans and their partners. This project could provide an opportunity to pilot a scalable model of treating PTSD within the Veterans Affairs healthcare system and leverage the benefits of MDMA for veterans with PTSD, as well as the downstream benefits to their partner on both individual and relationship functioning. <span>ClinicalTrials.gov</span><svg><path></path></svg> Identifier: NCT05979844.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000619/pdfft?md5=c448cefa2a9e9925a98d47ae3d04c084&pid=1-s2.0-S2451865424000619-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141138347","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}

{"title":"Validating nasogastric tube placement with pH testing: A randomized controlled trial protocol","authors":"Stefano Mancin ,&nbsp;Pietro Stallone ,&nbsp;Valeria Siro ,&nbsp;Manuela Pastore ,&nbsp;Daniela Cattani ,&nbsp;Diego Lopane ,&nbsp;Alessandra Dacomi ,&nbsp;Francesco Carlo Tartaglia ,&nbsp;Alessandro Bellone ,&nbsp;Francesca Serazzi ,&nbsp;Georges Laffoucriere ,&nbsp;Chiara Coldani ,&nbsp;Giuseppina Tomaiuolo ,&nbsp;Beatrice Mazzoleni","doi":"10.1016/j.conctc.2024.101312","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101312","url":null,"abstract":"<div><h3>Background</h3><p>Enteral nutrition (EN) is preferred when oral feeding is not possible. The use of the Nasogastric Tube (NGT) ensures rapid and low-risk nutrient administration. However, confirming the placement through chest radiography, besides delaying the initiation of nutritional therapy, exposes patients to radiation. The pH test of gastric aspirate provides a quicker check for NGT placement, but its reliability is compromised by challenges related to aspirating gastric secretions.</p></div><div><h3>Study objective</h3><p>The main objective of this study is to assess the high-performance placement of NGTs for nutritional purposes, optimizing the evaluation of correct insertion through pH testing using an electronic pH meter. Additionally, the study aims to evaluate patient tolerance to the intervention.</p></div><div><h3>Materials and methods</h3><p>This single-center RCT will include 150 EN candidate patients divided into three groups. Each group will use distinct NGTs, evaluating placement through pH testing and chest radiography for safety. Tolerance, complications related to NGT placement, and costs will be assessed, with data collected anonymously through a secure electronic database.</p></div><div><h3>Ethical considerations</h3><p>authorization no. 3624, Territorial Ethical Committee Lombardy 5, October 20, 2023.</p></div><div><h3>Implications and perspectives</h3><p>This protocol introduces innovative technologies, such as advanced NGTs and an electronic pH meter, aiming to optimize enteral nutrition management. This RCT focuses on replacing X-rays as the primary method for verifying NGT placement, thereby reducing costs, time, and patient exposure to radiation. Data analysis may provide insights into managing patients on pH-altering medication. Implementing innovative technologies has the potential to reduce errors and improve economic efficiency and process sustainability.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000590/pdfft?md5=2ec2ac4371f7fe5730bff70a37825821&pid=1-s2.0-S2451865424000590-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141095985","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}