journal
https://read.qxmd.com/read/39026376/personality-vulnerabilities-and-adverse-event-reporting-in-phase-1-clinical-studies
#1
LETTER
Joanna Skommer, Krish Gunesh, Thomas M Polasek
BACKGROUND: Phase 1 clinical trials involve rigorous safety monitoring to identify any adverse effects of investigational treatments. There is growing evidence that healthy volunteers recruited in these studies may differ with respect to personality traits from the general population. This, in turn, may have a significant impact on the reporting of adverse events, particularly in trials investigating psychoactive treatments, including the psychedelic substances. MAIN BODY: This analysis stems from our combined experience as investigators in phase 1 clinical trials and conveys an experiential understanding of the impact of psychological heterogeneity on study participation, reporting of adverse events and study outcomes...
July 18, 2024: Trials
https://read.qxmd.com/read/39026369/correction-the-effectiveness-of-multidisciplinary-interventions-based-on-health-belief-model-on-musculoskeletal-pain-in-the-elderly-living-in-nursing-homes-a-study-protocol-for-a-randomized-controlled-trial
#2
Sogand Habibi, Sedigheh Sadat Tavafan, Reza Maghbouli, Ali Montazeri
No abstract text is available yet for this article.
July 18, 2024: Trials
https://read.qxmd.com/read/39020446/bringing-optimised-covid-19-vaccine-schedules-to-immunocompromised-populations-boost-ic-study-protocol-for-an-adaptive-randomised-controlled-clinical-trial
#3
JOURNAL ARTICLE
David W J Griffin, Michael Dymock, Germaine Wong, C Orla Morrissey, Sharon R Lewin, Allen C Cheng, Kirsten Howard, Julie A Marsh, Kanta Subbarao, Michelle Hagenauer, Janine Roney, Anthony Cunningham, Tom Snelling, James H McMahon
BACKGROUND: Immunocompromised hosts (ICH) experience more breakthrough infections and worse clinical outcomes following infection with COVID-19 than immunocompetent people. Prophylactic monoclonal antibody therapies can be challenging to access, and escape variants emerge rapidly. Immunity conferred through vaccination remains a central prevention strategy for COVID-19. COVID-19 vaccines do not elicit optimal immunity in ICH but boosting, through additional doses of vaccine improves humoral and cellular immune responses...
July 17, 2024: Trials
https://read.qxmd.com/read/39020430/reflections-on-the-challenges-of-conducting-an-international-multicentre-randomized-controlled-trial-of-balance-training-in-addition-to-pulmonary-rehabilitation-and-its-impact-on-fall-incidence-in-people-with-copd
#4
MULTICENTER STUDY
Anastasia N L Newman, Marla K Beauchamp, Cindy Ellerton, Roger Goldstein, Jennifer A Alison, Gail Dechman, Kimberley J Haines, Samantha L Harrison, Anne E Holland, Annemarie L Lee, Alda Marques, Lissa Spencer, Michael K Stickland, Elizabeth H Skinner, Pat G Camp, Michelle E Kho, Dina Brooks
BACKGROUND: Pulmonary rehabilitation (PR) is accepted as standard care for individuals with COPD. We conducted an international, multi-centred randomized controlled trial (RCT) to determine if adding balance training to PR would reduce the incidence of falls in people with COPD. While there have been many trials investigating the effectiveness of PR, few have involved international collaboration. Successful execution of rehabilitation trials requires a significant investment of time, staffing, and resources...
July 17, 2024: Trials
https://read.qxmd.com/read/39020408/hope-groups-a-protocol-for-a-cluster-randomized-controlled-trial-of-psychosocial-mental-health-and-parenting-support-groups-for-ukrainian-caregivers-during-war-and-conflict
#5
JOURNAL ARTICLE
Sydney Tucker, Nicole Baldonado, Olha Ruina, Oliver Ratmann, Seth Flaxman, Lyudmyla Bryn, Jamie Lachman, Evgenia Taradaika, G J Melendez-Torres, Inge Vallance, Philip Goldman, Lucie Cluver, Susan Hillis
BACKGROUND: In 2021, more than two-thirds of the world's children lived in a conflict-affected country. In 2022, 13 million Ukrainians were forced to flee their homes after Russia's full-scale invasion. Hope Groups are a 12-session psychosocial, mental health, and parenting support intervention designed to strengthen parents, caregivers, and children affected by war and crisis. The primary objective of this study is to evaluate the effectiveness of Hope Groups among Ukrainians affected by war, compared to a wait-list control group...
July 17, 2024: Trials
https://read.qxmd.com/read/39014498/the-update-trial-uvb-phototherapy-in-dermatology-for-atopic-eczema-study-protocol-for-a-randomized-controlled-trial-of-narrowband-uvb-with-optimal-topical-therapy-versus-optimal-topical-therapy-in-patients-with-atopic-eczema
#6
JOURNAL ARTICLE
Eva Knöps, Phyllis Spuls, Ruben Duijnhoven, Marcel Dijkgraaf, Marit van Barreveld, Bernd Arents, Annefloor van Enst, Floor Garritsen, Maruschka Merkus, Pina Middelkamp-Hup, Annelie Musters, Angela Bosma, Ariënna Hyseni, Jitske Dijkstra, Dirk Jan Hijnen, Louise Gerbens
BACKGROUND: Narrowband ultraviolet B (NB-UVB) phototherapy is commonly prescribed for patients with moderate-to-severe atopic eczema (AE). The efficacy of NB-UVB, however, has not yet properly been established, as current evidence is of low certainty. Our aim is to assess the short-term and long-term (cost-)effectiveness and safety of NB-UVB in adult AE patients by performing a pragmatic, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial. This protocol outlines its methodology...
July 16, 2024: Trials
https://read.qxmd.com/read/39014495/a-randomized-embedded-pragmatic-bayesian-clinical-trial-examining-clinical-decision-support-for-high-flow-nasal-cannula-management-in-children-with-bronchiolitis-design-and-statistical-analysis-plan
#7
JOURNAL ARTICLE
Christopher M Horvat, Srinivasan Suresh, Nathan James, Rajesh K Aneja, Alicia K Au, Scott Berry, Arthur Blumer, Kelly Bricker, Robert S B Clark, Heidilyn Dolinich, Sheila Hahner, Christina Jockel, Jordan Kalivoda, India Loar, Denee Marasco, Adrienne Marcinick, Oscar Marroquin, Jonathan O'brien, Jonathan Pelletier, Sriram Ramgopal, Shekhar Venkataraman, Derek C Angus, Gabriella Butler
BACKGROUND: High flow nasal cannula (HFNC) has been increasingly adopted in the past 2 decades as a mode of respiratory support for children hospitalized with bronchiolitis. The growing use of HFNC despite a paucity of high-quality data regarding the therapy's efficacy has led to concerns about overutilization. We developed an electronic health record (EHR) embedded, quality improvement (QI) oriented clinical trial to determine whether standardized management of HFNC weaning guided by clinical decision support (CDS) results in a reduction in the duration of HFNC compared to usual care for children with bronchiolitis...
July 16, 2024: Trials
https://read.qxmd.com/read/39014430/effect-of-lung-volume-preservation-during-spontaneous-breathing-trial-on-successful-extubation-in-patients-receiving-mechanical-ventilation-protocol-for-a-multicenter-clinical-trial
#8
JOURNAL ARTICLE
Carles Subirà, Gina Rognoni, Herbert Baquerizo, Carolina García, Sara Cabañes, Maria de la Torre, Beatriz Quevedo, Cristina Pedrós, Ana I Tizón, Natalia Murillo, Laura Parro, Fernando Eiras, Gemma Rialp, Susana Altaba, Alejandro González-Castro, Andrés F Pacheco, Pablo Bayoumi, Norma Gómez-Medrano, Imma Vallverdú, Áurea Higón, María D Navarro, Alirio Falcón, Elena Keough, David Arizo, Juan F Martínez, Núria Durán, Raquel Rodríguez, Melinda R Popoviciu-Koborzan, Isabel Guerrero, Pablo Concha, Patricia Barral, Montserrat Batlle, Sílvia Cano, Silvia Garcia-Castrillon, Xavier Andorrà, Yenifher Tua, Anna Arnau, Rafael Fernández
BACKGROUND: In standard weaning from mechanical ventilation, a successful spontaneous breathing test (SBT) consisting of 30 min 8 cmH2 O pressure-support ventilation (PSV8) without positive end-expiratory pressure (PEEP) is followed by extubation with continuous suctioning; however, these practices might promote derecruitment. Evidence supports the feasibility and safety of extubation without suctioning. Ultrasound can assess lung aeration and respiratory muscles. We hypothesize that weaning aiming to preserve lung volume can yield higher rates of successful extubation...
July 16, 2024: Trials
https://read.qxmd.com/read/39014428/statistical-analysis-plan-for-cluster-randomised-trial-to-evaluate-a-community-level-complementary-food-safety-and-hygiene-and-nutrition-intervention-in-mali-the-maaciwara-study
#9
JOURNAL ARTICLE
Laura Quinn, James Martin, Evans Asamane, Semira Manaseki-Holland, Richard J Lilford, Lacina Traore, Jacqueline Thompson, Samuel I Watson, Karla Hemming
BACKGROUND: Diarrheal disease is a significant cause of morbidity and mortality in under-fives in many low- and middle-income countries. Changes in food safety, hygiene practices, and nutrition around the weaning period may reduce the risk of disease and improve infant development. The MaaCiwara study aims to evaluate the effectiveness of a community-based educational intervention designed to improve food safety and hygiene behaviours, as well as child nutrition. This update article describes the statistical analysis plan for the MaaCiwara study in detail...
July 16, 2024: Trials
https://read.qxmd.com/read/39010232/prenatal-affective-cognitive-training-to-reduce-the-risk-of-postpartum-depression-pact-study-protocol-for-a-randomized-controlled-trial
#10
JOURNAL ARTICLE
Anne J Bjertrup, Jeanne Kofoed, Ida Egmose, Katrine Wendelboe, Victoria Southgate, Mette S Væver, Kamilla W Miskowiak
BACKGROUND: Postpartum depression (PPD) affects 30-50% of women with a history of previous depression or bipolar disorder and 8% of women with no history of depression. Negative cognitive biases in the perception of infant cues and difficulties with emotion regulation are replicated risk factors. Current interventions focus on detecting and treating rather than preventing PPD. The aim of this randomized controlled intervention trial is therefore to investigate the potential prophylactic effects of prenatal affective cognitive training for pregnant women at heightened risk of PPD...
July 15, 2024: Trials
https://read.qxmd.com/read/39010208/prompt-closure-versus-gradual-weaning-of-external-ventricular-drain-for-hydrocephalus-following-aneurysmal-subarachnoid-haemorrhage-a-statistical-analysis-plan-for-the-drain-randomised-clinical-trial
#11
JOURNAL ARTICLE
Tenna Capion, Alexander Lilja-Cyron, Marianne Juhler, Kirsten Møller, Angelika Sorteberg, Pål André Rønning, Frantz Rom Poulsen, Joakim Wismann, Anders Emil Schack, Celina Ravlo, Jørgen Isaksen, Jane Lindschou, Christian Gluud, Tiit Mathiesen, Markus Harboe Olsen
BACKGROUND: Insertion of an external ventricular drain (EVD) is a first-line treatment of acute hydrocephalus caused by aneurysmal subarachnoid haemorrhage (aSAH). Once the patient is clinically stable, the EVD is either removed or replaced by a permanent internal shunt. The optimal strategy for cessation of the EVD is unknown. Prompt closure carries a risk of acute hydrocephalus or redundant shunt implantations, whereas gradual weaning may increase the risk of EVD-related infections...
July 15, 2024: Trials
https://read.qxmd.com/read/39010171/study-on-the-preventive-effect-of-dexmedetomidine-on-anesthetic-associated-sleep-disturbance-in-young-to-middle-aged-female-patients-undergoing-hysteroscopy-a-study-protocol-for-a-crossover-randomized-controlled-trial
#12
JOURNAL ARTICLE
Xueru Li, Lijuan Yan, Linhong Wang, Hanshen Chen, Bin Yang
BACKGROUND: Postoperative sleep disturbance has a potentially detrimental effect on postoperative recovery. Perioperative patients are affected by several factors. General anesthesia induces a non-physiological state that does not resemble natural sleep. Exposure to propofol/sevoflurane can lead to desynchronization of the circadian rhythm, which may result in postoperative sleep disturbance characterized by mid-cycle advancement of sleep and daytime sleepiness. Dexmedetomidine is a highly selective α2-adrenoceptor agonist with a unique sedative effect that facilitates the transition from sleep to wakefulness...
July 15, 2024: Trials
https://read.qxmd.com/read/39003481/optimising-a-digitally-delivered-behavioural-weight-loss-programme-study-protocol-for-a-factorial-cluster-randomised-controlled-trial
#13
JOURNAL ARTICLE
Gina M Wren, Dimitrios A Koutoukidis, Jadine Scragg, Grace Preston, Marianne Hennessy, Daisy Estephane, Michael Whitman, Susan A Jebb
BACKGROUND: Digitally delivered weight loss programmes can provide a convenient, potentially cheaper, and scalable treatment option for people who may need to lose weight. However, outcomes are often inferior to in-person interventions in the long-term. This trial will use principles from the Multiphase Optimisation Strategy (MOST) framework to test whether it can enhance the effectiveness of a commercial digital behavioural weight loss programme. This trial aims to identify an optimised combination of four intervention components to enhance weight loss over a 24-week period...
July 13, 2024: Trials
https://read.qxmd.com/read/38997767/development-and-preliminary-evaluation-of-a-suicidal-risk-assessment-protocol-in-a-randomised-controlled-trial-using-the-patient-health-questionnaire-phq-9
#14
RANDOMIZED CONTROLLED TRIAL
Vari Wileman, Serena McGuinness, Louise Sweeney, Christine Norton, Laura Miller, Imogen Stagg, Ronan O'Carroll, Rona Moss-Morris
BACKGROUND: Participants in research trials often disclose severe depression symptoms, including thoughts of self-harm and suicidal ideation, in validated self-administered questionnaires such as the Patient Health Questionnaire (PHQ-9). However, there is no standard protocol for responding to such disclosure, and the opportunity to support people at risk is potentially missed. We developed and evaluated a risk assessment protocol for the IBD-BOOST randomised controlled trial (ISRCTN71618461 09/09/2019)...
July 12, 2024: Trials
https://read.qxmd.com/read/38997765/a-randomized-controlled-trial-to-assess-if-changing-sleep-timing-can-improve-glucose-metabolism-in-people-with-prediabetes-and-type-2-diabetes
#15
RANDOMIZED CONTROLLED TRIAL
Emma J Bouman, Romy Slebe, Dirk Jan Stenvers, Petra J M Elders, Joline W J Beulens, Femke Rutters
BACKGROUND: Social jetlag is a chronic disruption of sleep timing that is characterized by different sleep timing during workdays and free days. Social jetlag has been associated with disturbed glucose metabolism, insulin resistance, and increased risk of metabolic syndrome and type 2 diabetes. In this study, we aim to investigate whether a combination of bright light therapy in the morning, bright light reduction in the evening and sleep advance instructions for 3 weeks reduces social jetlag and if this results in improvement of glycemic and metabolic control, sleep, mood and quality of life after 3 and 12 weeks in people with prediabetes and type 2 diabetes and to assess possible mediators, compared to regular sleep habits...
July 12, 2024: Trials
https://read.qxmd.com/read/38997739/the-effectiveness-of-expressive-art-therapy-on-infertile-women-undergoing-surgery-study-protocol-for-a-randomized-controlled-trial
#16
JOURNAL ARTICLE
Li Liu, Huiyan Yang, Anjiang Lei, Huaxuan You
BACKGROUND: Infertility produces infertility-related stress in both members of infertile couples, especially for infertile women. Some studies verified the negative relationship between infertility-related stress and outcomes of infertility treatments. Effective mental health care during fertility treatment is urgently needed, but there has been a lack of efficient support services. To reduce the infertility-related stress of infertile women, expressive art therapeutic schemes will be organized and implemented by certified international expressive art therapists...
July 12, 2024: Trials
https://read.qxmd.com/read/38992786/the-development-of-a-set-of-key-points-to-aid-clinicians-and-researchers-in-designing-and-conducting-n-of-1-trials
#17
JOURNAL ARTICLE
Robin Chatters, Olivia Hawksworth, Steven Julious, Andrew Cook
INTRODUCTION: n-of-1 trials are undertaken to optimise the evaluation of health technologies in individual patients. They involve a single patient receiving treatments, both interventional and control, consecutively over set periods of time, the order of which is decided at random. Although n-of-1 trials are undertaken in medical research it could be argued they have the utility to be undertaken more frequently. We undertook the National Institute for Health Research (NIHR) commissioned DIAMOND (Development of generalisable methodology for n-of-1 trials delivery for very low volume treatments) project to develop key points to assist clinicians and researchers in designing and conducting n-of-1 trials...
July 11, 2024: Trials
https://read.qxmd.com/read/38992785/correction-effectiveness-of-a-school-based-life-gatekeeper-training-program-on-suicide-prevention-in-china-protocol-for-a-randomized-controlled-trial
#18
Diyang Qu, Xuan Zhang, Dongyu Liu, Bowen Liu, Dongyang Chen, Chengxi Cai, Jing An, Shekhar Saxena, Runsen Chen
No abstract text is available yet for this article.
July 11, 2024: Trials
https://read.qxmd.com/read/38992720/a-phase-iii-randomized-clinical-trial-comparing-laparoscopic-radical-hysterectomy-based-on-open-state-with-abdominal-radical-hysterectomy-in-patients-with-early-stage-cervical-cancer
#19
COMPARATIVE STUDY
Xin Zhao, Yansong Liu, Jumin Niu, Yulin Shi
BACKGROUND: Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women, The standard treatment recommendation for women with early cervical cancer is radical hysterectomy with pelvic lymph node dissection, however, articles published in recent years have concluded that the treatment outcome of laparoscopic surgery for cervical cancer is inferior to that of open surgery. Thus, we choose a surgically new approach; the laparoscopic cervical cancer surgery in the open state is compared with the traditional open cervical cancer surgery, and we hope that patients can still have a good tumor outcome and survival outcome...
July 11, 2024: Trials
https://read.qxmd.com/read/38987846/smartphone-based-intervention-for-postpartum-depressive-symptoms-smart-e-moms-study-protocol-for-a-randomized-controlled-trial
#20
JOURNAL ARTICLE
Daria Daehn, Caroline Meyer, Viola Loew, Jessica Wabiszczewicz, Steffi Pohl, Maria Böttche, Silke Pawils, Babette Renneberg
BACKGROUND: Postpartum depression constitutes a significant public health issue, with prevalence rates ranging between 8 and 19% in high-income nations. Nevertheless, numerous barriers, including time constraints, societal stigmatization, and feelings of shame, contribute to the limited utilization of healthcare services during the postpartum period. Digital interventions offer an opportunity to enhance care for women experiencing postpartum depressive symptoms. METHODS: We will conduct a two-arm randomized controlled trial to assess the effectiveness of a smartphone-based intervention in comparison to a treatment-as-usual control group in Germany...
July 10, 2024: Trials
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